Prasterone (Dehydroepiandrosterone) in Treating Postmenopausal Cancer Survivors With Vaginal Symptoms
This study is ongoing, but not recruiting participants.
Sponsor:
North Central Cancer Treatment Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01376349
First received: June 17, 2011
Last updated: February 24, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: Dehydroepiandrosterone (DHEA) may help relieve vaginal symptoms in female cancer survivors.
PURPOSE: This randomized phase III trial studies DHEA to see how well it works compared to placebo in treating postmenopausal cancer survivors with vaginal symptoms.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Drug: prasterone Other: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Supportive Care |
| Official Title: | Vaginal DHEA for Vaginal Symptoms: A Phase III Randomized, Double Blind, Placebo- Controlled Trial |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Prasterone
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Alleviation of the most bothersome vaginal symptom (vaginal dryness or dyspareunia) over 12 weeks [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Impact of vaginal DHEA on maturation index and pH [ Designated as safety issue: No ]
- Impact of vaginal DHEA on sex steroid concentrations (estradiol, free testosterone, estrone, and DHEA-S) and markers of bone turnover (osteocalcin and bone alkaline phosphatase) [ Designated as safety issue: No ]
| Estimated Enrollment: | 456 |
| Study Start Date: | July 2011 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Participants apply a low dose of vaginal prasterone (dehydroepiandrosterone [DHEA]) gel once daily (QD), at bed time, for 12 weeks.
|
Drug: prasterone
Applied vaginally
|
|
Experimental: Arm II
Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks.
|
Drug: prasterone
Applied vaginally
|
|
Placebo Comparator: Arm III
Participants apply a vaginal placebo gel QD, at bed time, for 12 weeks.
|
Other: placebo
Applied vaginally
|
Detailed Description:
OBJECTIVES:
Primary
- To determine the effectiveness of two doses of daily vaginal prasterone (dehydroepiandrosterone [DHEA]) versus placebo for alleviation of the most bothersome vaginal symptom (vaginal dryness or dyspareunia) over 12 weeks.
Secondary
- To evaluate any toxicities arising from DHEA in this patient population. (Exploratory)
- To evaluate the impact of vaginal DHEA on negative sexual thoughts, sexual function and urologic symptoms. (Exploratory)
- To explore the role of psychologic (mood, stress), physical (demographics and treatment variables) and situational factors (partner variables and fatigue) as predictors of vaginal dryness and performance outcomes at baseline and at various endpoints throughout the study. (Exploratory)
- To explore the characteristics of vaginal atrophy and the relationship between vaginal atrophy and quality-of-life questionnaire responses and exposure to hormonal therapy (tamoxifen, exemestane, anastrozole, or letrozole). (Exploratory)
- To examine the effects of the use of open-label vaginal DHEA gel over 8 weeks in women completing the placebo gel arm of the randomized trial. (Exploratory)
- To evaluate the impact of vaginal DHEA on maturation index and pH (select institutions). (Correlative)
- To evaluate the impact of vaginal DHEA on sex steroid concentrations (estradiol, free testosterone, estrone, and DHEA-S) and markers of bone turnover (osteocalcin and bone alkaline phosphatase). (Correlative)
- To bank blood products for future studies. (Correlative)
OUTLINE: This is a multicenter study. Patients are stratified according to current tamoxifen therapy (yes vs no), concurrent aromatase inhibitor (anastrozole/letrozole vs exemestane vs none), hysterectomy (yes vs no), and cigarette smoking (current vs past vs never). Patients are randomized to 1 of 3 treatment arms.
- Arm I: Participants apply a low dose of vaginal prasterone (dehydroepiandrosterone [DHEA]) gel once daily (QD), at bed time, for 12 weeks.
- Arm II: Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks.
Arm III: Participants apply a vaginal placebo gel QD, at bed time, for 12 weeks.
- Optional Continuation Phase (for placebo arm only): Participants apply a high dose of vaginal DHEA gel QD, at bed time, for 12 weeks.
Participants undergo blood sample collection at baseline and during weeks 11-12 for estradiol, free testosterone, estrone, DHEA-sulfate, osteocalcin, and bone alkaline phosphatase analysis. Some participants also undergo vaginal cells collection and vaginal pH tests.
Participants may complete the Profile of Mood States (POMS), the Perceived Stress Scale (PSS), the Fatigue: Vitality subscale of the SF-36, the Vaginal Symptom Quality Questionnaire, the DHEA Side Effect Questionnaire, the Female Sexual Function Index (FSFI), the Sexually Related Intrusive Thoughts - ITS, Impact of Treatment Scale, the Urogenital Atrophy Questionnaire, and the Subject Global Impression of Change at baseline and periodically during study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Postmenopausal women with a history of breast or gynecologic cancer (currently no evidence of disease)
Postmenopausal status determined by the following criteria:
- 12 months without a period or bilateral oophorectomy or complete chemical ovarian suppression for the past 12 months with continued suppression planned throughout the course of the study
- FSH and an estradiol value in the postmenopausal range (generally FSH >40 IU/L and estradiol < 10 pg/mL, depending on laboratory) if 9 months without a period OR post hysterectomy with at least one ovary remaining and less than 55 years old
- For age 55 or older, menopausal status does not need to be determined by laboratory exams
- Significant vaginal complaints defined as persistent vaginal dryness and/or pain with intercourse (dyspareunia) of sufficient severity to make a patient desire therapeutic intervention
- Eligibility questionnaire response must be moderate or worse levels of severity on one of the two symptoms, either dryness or dyspareunia
- Vaginal symptoms must have been present ≥ 2 months prior to randomization
PATIENT CHARACTERISTICS:
- Life expectancy > 12 months
- ECOG performance status 0 or 1
- Ability to complete questionnaires by themselves or with assistance
- Willing to return to NCCTG enrolling institution for follow-up
- Willing to provide blood samples for correlative research purposes
- Willing to undergo brief pelvic exam at baseline and week 11-12, if institution participating in that portion of the study
- No current diagnosis of an active vaginal infection; if symptoms of vaginal infection (i.e., foul discharge, fever) present, then infection must be ruled out
No diagnosis of any of the following conditions within the past five years:
- Essential vulvodynia
- Vulvar vestibulitis
- Bartholin cyst/abscess
- History of Bartholin gland surgery
- Lichen sclerosis
- Lichen planus of the vulvovaginal region
- Desquamative vaginitis
No history or current diagnosis of any of the following conditions (ever):
- Vulvar or vaginal dysplasia
- Vaginal prolapse
- No women of childbearing potential or premenopausal women
PRIOR CONCURRENT THERAPY:
- No initiation or discontinuation of tamoxifen or aromatase inhibitors ≤ 2 months prior to randomization or plan to initiate or discontinue any of these medications during the 12-week study
No concurrent chemotherapy
- Long-term adjuvant trastuzumab, lapatinib, and/or bevacizumab is allowed
Not planning to use any vaginal preparations during the study period (including any over-the-counter or herbal preparations)
- Water-based lubricants, such as KY jelly, are allowed during sexual intercourse
No use of any daily non-hormonal vaginal preparations ≤ 1 week prior to study entry
- Patients who stop agent may be enrolled after 1 week
- More then 4 weeks since prior and no concurrent use of any estrogen product or any kind of hormonal vaginal product including bio-identical hormones, estriol, or any androgen product
- No concurrent pharmacologic soy or phytoestrogen preparations (dietary intake of soy [i.e., soy milk] is acceptable)
- Not on a placebo-controlled trial for endocrine therapy
- No prior or concurrent pelvic radiotherapy
No prior radical pelvic surgery, specifically vaginectomy or pelvic exenteration
- Prior total abdominal hysterectomy (TAH) and/or bilateral salpingo-oophorectomy (BSO) allowed
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01376349
Hide Study Locations
Hide Study LocationsLocations
| United States, Arizona | |
| Mayo Clinic Scottsdale | |
| Scottsdale, Arizona, United States, 85259-5499 | |
| United States, Colorado | |
| Aurora Presbyterian Hospital | |
| Aurora, Colorado, United States, 80012 | |
| Boulder Community Hospital | |
| Boulder, Colorado, United States, 80301-9019 | |
| Penrose Cancer Center at Penrose Hospital | |
| Colorado Springs, Colorado, United States, 80933 | |
| St. Anthony Central Hospital | |
| Denver, Colorado, United States, 80204 | |
| Porter Adventist Hospital | |
| Denver, Colorado, United States, 80210 | |
| Presbyterian - St. Luke's Medical Center | |
| Denver, Colorado, United States, 80218 | |
| CCOP - Colorado Cancer Research Program | |
| Denver, Colorado, United States, 80222 | |
| St. Joseph Hospital | |
| Denver, Colorado, United States, 80218 | |
| Rose Medical Center | |
| Denver, Colorado, United States, 80220 | |
| Swedish Medical Center | |
| Englewood, Colorado, United States, 80110 | |
| Poudre Valley Hospital | |
| Fort Collins, Colorado, United States, 80524 | |
| Front Range Cancer Specialists | |
| Fort Collins, Colorado, United States, 80528 | |
| North Colorado Medical Center | |
| Greeley, Colorado, United States, 80631 | |
| Littleton Adventist Hospital | |
| Littleton, Colorado, United States, 80122 | |
| Sky Ridge Medical Center | |
| Lone Tree, Colorado, United States, 80124 | |
| Hope Cancer Care Center at Longmont United Hospital | |
| Longmont, Colorado, United States, 80501 | |
| McKee Medical Center | |
| Loveland, Colorado, United States, 80539 | |
| Parker Adventist Hospital | |
| Parker, Colorado, United States, 80138 | |
| St. Mary - Corwin Regional Medical Center | |
| Pueblo, Colorado, United States, 81004 | |
| North Suburban Medical Center | |
| Thornton, Colorado, United States, 80229 | |
| Exempla Lutheran Medical Center | |
| Wheat Ridge, Colorado, United States, 80033 | |
| United States, Connecticut | |
| Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | |
| Hartford, Connecticut, United States, 06105 | |
| United States, Florida | |
| Herbert D. Kerman Regional Oncology Center - Daytona Beach | |
| Daytona Beach, Florida, United States, 32114 | |
| University of Florida Shands Cancer Center | |
| Gainesville, Florida, United States, 32610-0232 | |
| Mayo Clinic - Jacksonville | |
| Jacksonville, Florida, United States, 32224 | |
| United States, Hawaii | |
| Kapiolani Medical Center at Pali Momi | |
| Aiea, Hawaii, United States, 96701 | |
| Hawaii Medical Center - East | |
| Honolulu, Hawaii, United States, 96817 | |
| Cancer Research Center of Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| Kapiolani Medical Center for Women and Children | |
| Honolulu, Hawaii, United States, 96826 | |
| OnCare Hawaii, Incorporated - Lusitana | |
| Honolulu, Hawaii, United States, 96813 | |
| Queen's Cancer Institute at Queen's Medical Center | |
| Honolulu, Hawaii, United States, 96813 | |
| Straub Clinic and Hospital, Incorporated | |
| Honolulu, Hawaii, United States, 96813 | |
| OnCare Hawaii, Incorporated - Kuakini | |
| Honolulu, Hawaii, United States, 96817 | |
| Castle Medical Center | |
| Kailua, Hawaii, United States, 96734 | |
| Kauai Medical Clinic | |
| Lihue, Hawaii, United States, 96766 | |
| Maui Memorial Medical Center | |
| Wailuku, Hawaii, United States, 96793 | |
| Pacific Cancer Institute - Maui | |
| Wailuku, Hawaii, United States, 96793 | |
| United States, Idaho | |
| Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | |
| Boise, Idaho, United States, 83706 | |
| Idaho Urologic Institute, PA | |
| Meridian, Idaho, United States, 83642 | |
| United States, Illinois | |
| St. Joseph Medical Center | |
| Bloomington, Illinois, United States, 61701 | |
| Illinois CancerCare - Bloomington | |
| Bloomington, Illinois, United States, 61701 | |
| Illinois CancerCare - Canton | |
| Canton, Illinois, United States, 61520 | |
| Illinois CancerCare - Carthage | |
| Carthage, Illinois, United States, 62321 | |
| Illinois CancerCare - Eureka | |
| Eureka, Illinois, United States, 61530 | |
| Eureka Community Hospital | |
| Eureka, Illinois, United States, 61530 | |
| Galesburg Clinic, PC | |
| Galesburg, Illinois, United States, 61401 | |
| Illinois CancerCare - Havana | |
| Havana, Illinois, United States, 62644 | |
| Illinois CancerCare - Kewanee Clinic | |
| Kewanee, Illinois, United States, 61443 | |
| Illinois CancerCare - Macomb | |
| Macomb, Illinois, United States, 61455 | |
| Trinity Cancer Center at Trinity Medical Center - 7th Street Campus | |
| Moline, Illinois, United States, 61265 | |
| Moline, Illinois, United States, 61265 | |
| OSF Holy Family Medical Center | |
| Monmouth, Illinois, United States, 61462 | |
| Illinois CancerCare - Monmouth | |
| Monmouth, Illinois, United States, 61462 | |
| Community Cancer Center | |
| Normal, Illinois, United States, 61761 | |
| Illinois CancerCare - Community Cancer Center | |
| Normal, Illinois, United States, 61761 | |
| BroMenn Regional Medical Center | |
| Normal, Illinois, United States, 61761 | |
| Community Hospital of Ottawa | |
| Ottawa, Illinois, United States, 61350 | |
| Oncology Hematology Associates of Central Illinois, PC - Ottawa | |
| Ottawa, Illinois, United States, 61350 | |
| Cancer Treatment Center at Pekin Hospital | |
| Pekin, Illinois, United States, 61554 | |
| Illinois CancerCare - Pekin | |
| Pekin, Illinois, United States, 61603 | |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | |
| Peoria, Illinois, United States, 61615 | |
| Methodist Medical Center of Illinois | |
| Peoria, Illinois, United States, 61636 | |
| OSF St. Francis Medical Center | |
| Peoria, Illinois, United States, 61637 | |
| Proctor Hospital | |
| Peoria, Illinois, United States, 61614 | |
| CCOP - Illinois Oncology Research Association | |
| Peoria, Illinois, United States, 61615 | |
| Illinois CancerCare - Peru | |
| Peru, Illinois, United States, 61354 | |
| Illinois Valley Community Hospital | |
| Peru, Illinois, United States, 61354 | |
| Illinois CancerCare - Princeton | |
| Princeton, Illinois, United States, 61356 | |
| Illinois CancerCare - Spring Valley | |
| Spring Valley, Illinois, United States, 61362 | |
| CCOP - Carle Cancer Center | |
| Urbana, Illinois, United States, 61801 | |
| United States, Indiana | |
| Elkhart Clinic, LLC | |
| Elkhart, Indiana, United States, 46514-2098 | |
| Michiana Hematology-Oncology, PC - Elkhart | |
| Elkhart, Indiana, United States, 46514 | |
| Elkhart General Hospital | |
| Elkhart, Indiana, United States, 46515 | |
| St. Francis Hospital Cancer Care Services | |
| Indianapolis, Indiana, United States, 46237 | |
| Howard Community Hospital | |
| Kokomo, Indiana, United States, 46904 | |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | |
| La Porte, Indiana, United States, 46350 | |
| Saint Anthony Memorial Health Centers | |
| Michigan City, Indiana, United States, 46360 | |
| Michiana Hematology-Oncology, PC - South Bend | |
| Mishawaka, Indiana, United States, 46545-1470 | |
| Saint Joseph Regional Medical Center | |
| Mishawaka, Indiana, United States, 46545-1470 | |
| Michiana Hematology Oncology PC - Plymouth | |
| Plymouth, Indiana, United States, 46563 | |
| Reid Hospital & Health Care Services | |
| Richmond, Indiana, United States, 47374 | |
| Memorial Hospital of South Bend | |
| South Bend, Indiana, United States, 46601 | |
| CCOP - Northern Indiana CR Consortium | |
| South Bend, Indiana, United States, 46601 | |
| Michiana Hematology Oncology PC - La Porte | |
| Westville, Indiana, United States, 46391 | |
| United States, Iowa | |
| Bettendorf, Iowa, United States, 52722 | |
| Cedar Rapids Oncology Associates | |
| Cedar Rapids, Iowa, United States, 52403 | |
| Mercy Regional Cancer Center at Mercy Medical Center | |
| Cedar Rapids, Iowa, United States, 52403 | |
| Mercy Cancer Center - West Lakes | |
| Clive, Iowa, United States, 50325 | |
| Medical Oncology and Hematology Associates - West Des Moines | |
| Clive, Iowa, United States, 50325 | |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | |
| Des Moines, Iowa, United States, 50309 | |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | |
| Des Moines, Iowa, United States, 50309 | |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | |
| Des Moines, Iowa, United States, 50314 | |
| CCOP - Iowa Oncology Research Association | |
| Des Moines, Iowa, United States, 50309 | |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | |
| Des Moines, Iowa, United States, 50314 | |
| John Stoddard Cancer Center at Iowa Lutheran Hospital | |
| Des Moines, Iowa, United States, 50316 | |
| Mercy Medical Center - Sioux City | |
| Sioux City, Iowa, United States, 51102 | |
| Siouxland Hematology-Oncology Associates, LLP | |
| Sioux City, Iowa, United States, 51101 | |
| St. Luke's Regional Medical Center | |
| Sioux City, Iowa, United States, 51104 | |
| Methodist West Hospital | |
| West Des Moines, Iowa, United States, 50266-7700 | |
| United States, Kansas | |
| Cancer Center of Kansas, PA - Chanute | |
| Chanute, Kansas, United States, 66720 | |
| Cancer Center of Kansas, PA - Dodge City | |
| Dodge City, Kansas, United States, 67801 | |
| Cancer Center of Kansas, PA - El Dorado | |
| El Dorado, Kansas, United States, 67042 | |
| Cancer Center of Kansas - Fort Scott | |
| Fort Scott, Kansas, United States, 66701 | |
| Cancer Center of Kansas-Independence | |
| Independence, Kansas, United States, 67301 | |
| Cancer Center of Kansas, PA - Kingman | |
| Kingman, Kansas, United States, 67068 | |
| Lawrence Memorial Hospital | |
| Lawrence, Kansas, United States, 66044 | |
| Cancer Center of Kansas, PA - Liberal | |
| Liberal, Kansas, United States, 67901 | |
| Cancer Center of Kansas, PA - McPherson | |
| McPherson, Kansas, United States, 67460 | |
| Cancer Center of Kansas, PA - Newton | |
| Newton, Kansas, United States, 67114 | |
| Cancer Center of Kansas, PA - Parsons | |
| Parsons, Kansas, United States, 67357 | |
| Cancer Center of Kansas, PA - Pratt | |
| Pratt, Kansas, United States, 67124 | |
| Cancer Center of Kansas, PA - Salina | |
| Salina, Kansas, United States, 67401 | |
| Cancer Center of Kansas, PA - Wellington | |
| Wellington, Kansas, United States, 67152 | |
| Cancer Center of Kansas, PA - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| Associates in Womens Health, PA - North Review | |
| Wichita, Kansas, United States, 67208 | |
| Cancer Center of Kansas, PA - Medical Arts Tower | |
| Wichita, Kansas, United States, 67208 | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214 | |
| Via Christi Cancer Center at Via Christi Regional Medical Center | |
| Wichita, Kansas, United States, 67214 | |
| Cancer Center of Kansas, PA - Winfield | |
| Winfield, Kansas, United States, 67156 | |
| United States, Michigan | |
| Hickman Cancer Center at Bixby Medical Center | |
| Adrian, Michigan, United States, 49221 | |
| CCOP - Michigan Cancer Research Consortium | |
| Ann Arbor, Michigan, United States, 48106 | |
| Saint Joseph Mercy Cancer Center | |
| Ann Arbor, Michigan, United States, 48106-0995 | |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | |
| Dearborn, Michigan, United States, 48123-2500 | |
| Green Bay Oncology, Limited - Escanaba | |
| Escanaba, Michigan, United States, 49431 | |
| Genesys Hurley Cancer Institute | |
| Flint, Michigan, United States, 48503 | |
| Hurley Medical Center | |
| Flint, Michigan, United States, 48503 | |
| Genesys Regional Medical Center | |
| Grand Blanc, Michigan, United States, 48439 | |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | |
| Grosse Pointe Woods, Michigan, United States, 48236 | |
| Dickinson County Healthcare System | |
| Iron Mountain, Michigan, United States, 49801 | |
| Foote Memorial Hospital | |
| Jackson, Michigan, United States, 49201 | |
| Sparrow Regional Cancer Center | |
| Lansing, Michigan, United States, 48912-1811 | |
| St. Mary Mercy Hospital | |
| Livonia, Michigan, United States, 48154 | |
| Community Cancer Center of Monroe | |
| Monroe, Michigan, United States, 48162 | |
| Mercy Memorial Hospital - Monroe | |
| Monroe, Michigan, United States, 48162 | |
| St. Joseph Mercy Oakland | |
| Pontiac, Michigan, United States, 48341-2985 | |
| Mercy Regional Cancer Center at Mercy Hospital | |
| Port Huron, Michigan, United States, 48060 | |
| Seton Cancer Institute at Saint Mary's - Saginaw | |
| Saginaw, Michigan, United States, 48601 | |
| Lakeside Cancer Specialists, PLLC | |
| Saint Joseph, Michigan, United States, 49085 | |
| Lakeland Regional Cancer Care Center - St. Joseph | |
| Saint Joseph, Michigan, United States, 49085 | |
| St. John Macomb Hospital | |
| Warren, Michigan, United States, 48093 | |
| United States, Minnesota | |
| MeritCare Bemidji | |
| Bemidji, Minnesota, United States, 56601 | |
| St. Joseph's Medical Center | |
| Brainerd, Minnesota, United States, 56401 | |
| Fairview Ridges Hospital | |
| Burnsville, Minnesota, United States, 55337 | |
| Mercy and Unity Cancer Center at Mercy Hospital | |
| Coon Rapids, Minnesota, United States, 55433 | |
| CCOP - Duluth | |
| Duluth, Minnesota, United States, 55805 | |
| Essentia Health - Duluth Clinic | |
| Duluth, Minnesota, United States, 55805-1983 | |
| Miller - Dwan Medical Center | |
| Duluth, Minnesota, United States, 55805 | |
| Fairview Southdale Hospital | |
| Edina, Minnesota, United States, 55435 | |
| Mercy and Unity Cancer Center at Unity Hospital | |
| Fridley, Minnesota, United States, 55432 | |
| Hutchinson Area Health Care | |
| Hutchinson, Minnesota, United States, 55350 | |
| Immanuel St. Joseph's | |
| Mankato, Minnesota, United States, 56002 | |
| Minnesota Oncology - Maplewood | |
| Maplewood, Minnesota, United States, 55109 | |
| HealthEast Cancer Care at St. John's Hospital | |
| Maplewood, Minnesota, United States, 55109 | |
| Hennepin County Medical Center - Minneapolis | |
| Minneapolis, Minnesota, United States, 55415 | |
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | |
| Minneapolis, Minnesota, United States, 55407 | |
| New Ulm Medical Center | |
| New Ulm, Minnesota, United States, 56073 | |
| Humphrey Cancer Center at North Memorial Outpatient Center | |
| Robbinsdale, Minnesota, United States, 55422-2900 | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| CentraCare Clinic - River Campus | |
| Saint Cloud, Minnesota, United States, 56303 | |
| Coborn Cancer Center | |
| Saint Cloud, Minnesota, United States, 56303 | |
| CCOP - Metro-Minnesota | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| Park Nicollet Cancer Center | |
| Saint Louis Park, Minnesota, United States, 55416 | |
| United Hospital | |
| Saint Paul, Minnesota, United States, 55102 | |
| St. Francis Cancer Center at St. Francis Medical Center | |
| Shakopee, Minnesota, United States, 55379 | |
| Regions Hospital Cancer Care Center | |
| St. Paul, Minnesota, United States, 55101 | |
| Lakeview Hospital | |
| Stillwater, Minnesota, United States, 55082 | |
| Ridgeview Medical Center | |
| Waconia, Minnesota, United States, 55387 | |
| Willmar Cancer Center at Rice Memorial Hospital | |
| Willmar, Minnesota, United States, 56201 | |
| Minnesota Oncology - Woodbury | |
| Woodbury, Minnesota, United States, 55125 | |
| United States, Missouri | |
| Mercy Clinic Cancer and Hematology - Rolla | |
| Rolla, Missouri, United States, 65401 | |
| Hulston Cancer Center at Cox Medical Center South | |
| Springfield, Missouri, United States, 65807 | |
| St. John's Regional Health Center | |
| Springfield, Missouri, United States, 65804 | |
| CCOP - Cancer Research for the Ozarks | |
| Springfield, Missouri, United States, 65804 | |
| United States, Montana | |
| Billings Clinic - Downtown | |
| Billings, Montana, United States, 59107-7000 | |
| Hematology-Oncology Centers of the Northern Rockies - Billings | |
| Billings, Montana, United States, 59102 | |
| St. Vincent Healthcare Cancer Care Services | |
| Billings, Montana, United States, 59101 | |
| CCOP - Montana Cancer Consortium | |
| Billings, Montana, United States, 59101 | |
| Bozeman Deaconess Cancer Center | |
| Bozeman, Montana, United States, 59715 | |
| St. James Healthcare Cancer Care | |
| Butte, Montana, United States, 59701 | |
| Benefis Sletten Cancer Institute | |
| Great Falls, Montana, United States, 59405 | |
| St. Peter's Hospital | |
| Helena, Montana, United States, 59601 | |
| Kalispell Regional Medical Center | |
| Kalispell, Montana, United States, 59901 | |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | |
| Missoula, Montana, United States, 59807 | |
| Montana Cancer Specialists at Montana Cancer Center | |
| Missoula, Montana, United States, 59807-7877 | |
| United States, Nebraska | |
| Cancer Resource Center - Lincoln | |
| Lincoln, Nebraska, United States, 68510 | |
| Lakeside Hospital | |
| Omaha, Nebraska, United States, 68130 | |
| CCOP - Missouri Valley Cancer Consortium | |
| Omaha, Nebraska, United States, 68106 | |
| Creighton University Medical Center | |
| Omaha, Nebraska, United States, 68131-2197 | |
| Immanuel Medical Center | |
| Omaha, Nebraska, United States, 68122 | |
| Alegant Health Cancer Center at Bergan Mercy Medical Center | |
| Omaha, Nebraska, United States, 68124 | |
| United States, New Mexico | |
| Lovelace Medical Center - Downtown | |
| Albuquerque, New Mexico, United States, 87102 | |
| Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital | |
| Albuquerque, New Mexico, United States, 87110 | |
| University of New Mexico Cancer Center | |
| Albuquerque, New Mexico, United States, 87131-5636 | |
| University of New Mexico Cancer Center - South | |
| Las Cruces, New Mexico, United States, 88011 | |
| United States, North Carolina | |
| Rutherford Hospital | |
| Rutherfordton, North Carolina, United States, 28139 | |
| United States, North Dakota | |
| Dakota Cancer Institute at Dakota Clinic - South University | |
| Fargo, North Dakota, United States, 58103 | |
| CCOP - MeritCare Hospital | |
| Fargo, North Dakota, United States, 58122 | |
| MeritCare Broadway | |
| Fargo, North Dakota, United States, 58102 | |
| Altru Cancer Center at Altru Hospital | |
| Grand Forks, North Dakota, United States, 58201 | |
| United States, Ohio | |
| Wood County Oncology Center | |
| Bowling Green, Ohio, United States, 43402 | |
| Adena Regional Medical Center | |
| Chillicothe, Ohio, United States, 45601 | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43215 | |
| Zangmeister Center | |
| Columbus, Ohio, United States, 43219 | |
| Riverside Methodist Hospital Cancer Care | |
| Columbus, Ohio, United States, 43214-3998 | |
| Doctors Hospital at Ohio Health | |
| Columbus, Ohio, United States, 43228 | |
| Mount Carmel Health - West Hospital | |
| Columbus, Ohio, United States, 43222 | |
| Grant Medical Center Cancer Care | |
| Columbus, Ohio, United States, 43215 | |
| Samaritan North Cancer Care Center | |
| Dayton, Ohio, United States, 45415 | |
| David L. Rike Cancer Center at Miami Valley Hospital | |
| Dayton, Ohio, United States, 45409 | |
| Good Samaritan Hospital | |
| Dayton, Ohio, United States, 45406 | |
| Grandview Hospital | |
| Dayton, Ohio, United States, 45405 | |
| CCOP - Dayton | |
| Dayton, Ohio, United States, 45420 | |
| Grady Memorial Hospital | |
| Delaware, Ohio, United States, 43015 | |
| Hematology Oncology Center | |
| Elyria, Ohio, United States, 44035 | |
| Community Cancer Center | |
| Elyria, Ohio, United States, 44035 | |
| Blanchard Valley Medical Associates | |
| Findlay, Ohio, United States, 45840 | |
| Middletown Regional Hospital | |
| Franklin, Ohio, United States, 45005-1066 | |
| Wayne Hospital | |
| Greenville, Ohio, United States, 45331 | |
| Charles F. Kettering Memorial Hospital | |
| Kettering, Ohio, United States, 45429 | |
| Fairfield Medical Center | |
| Lancaster, Ohio, United States, 43130 | |
| Lima Memorial Hospital | |
| Lima, Ohio, United States, 45804 | |
| Strecker Cancer Center at Marietta Memorial Hospital | |
| Marietta, Ohio, United States, 45750 | |
| Northwest Ohio Oncology Center | |
| Maumee, Ohio, United States, 43537-1839 | |
| Knox Community Hospital | |
| Mount Vernon, Ohio, United States, 43050 | |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | |
| Newark, Ohio, United States, 43055 | |
| St. Charles Mercy Hospital | |
| Oregon, Ohio, United States, 43616 | |
| Toledo Clinic - Oregon | |
| Oregon, Ohio, United States, 43616 | |
| Southern Ohio Medical Center Cancer Center | |
| Portsmouth, Ohio, United States, 45662 | |
| Community Hospital of Springfield and Clark County | |
| Springfield, Ohio, United States, 45505 | |
| Flower Hospital Cancer Center | |
| Sylvania, Ohio, United States, 43560 | |
| Mercy Hospital of Tiffin | |
| Tiffin, Ohio, United States, 44883 | |
| Medical University of Ohio Cancer Center | |
| Toledo, Ohio, United States, 43614 | |
| St. Anne Mercy Hospital | |
| Toledo, Ohio, United States, 43623 | |
| Toledo Clinic, Incorporated - Main Clinic | |
| Toledo, Ohio, United States, 43623 | |
| CCOP - Toledo Community Hospital | |
| Toledo, Ohio, United States, 43617 | |
| Toledo Hospital | |
| Toledo, Ohio, United States, 43606 | |
| St. Vincent Mercy Medical Center | |
| Toledo, Ohio, United States, 43608 | |
| UVMC Cancer Care Center at Upper Valley Medical Center | |
| Troy, Ohio, United States, 45373-1300 | |
| Fulton County Health Center | |
| Wauseon, Ohio, United States, 43567 | |
| Mount Carmel St. Ann's Cancer Center | |
| Westerville, Ohio, United States, 43081 | |
| United States Air Force Medical Center - Wright-Patterson | |
| Wright-Patterson Afb, Ohio, United States, 45433-5529 | |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | |
| Xenia, Ohio, United States, 45385 | |
| Genesis - Good Samaritan Hospital | |
| Zanesville, Ohio, United States, 43701 | |
| United States, Oregon | |
| Clackamas Radiation Oncology Center | |
| Clackamas, Oregon, United States, 97015 | |
| Providence Milwaukie Hospital | |
| Milwaukie, Oregon, United States, 97222 | |
| Providence Newberg Medical Center | |
| Newberg, Oregon, United States, 97132 | |
| Willamette Falls Hospital | |
| Oregon City, Oregon, United States, 97045 | |
| Providence Cancer Center at Providence Portland Medical Center | |
| Portland, Oregon, United States, 97213-2967 | |
| CCOP - Columbia River Oncology Program | |
| Portland, Oregon, United States, 97225 | |
| Providence St. Vincent Medical Center | |
| Portland, Oregon, United States, 97225 | |
| United States, Pennsylvania | |
| Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | |
| Allentown, Pennsylvania, United States, 18105 | |
| Lehigh Valley Hospital - Muhlenberg | |
| Bethlehem, Pennsylvania, United States, 18017 | |
| Geisinger Cancer Institute at Geisinger Health | |
| Danville, Pennsylvania, United States, 17822-0001 | |
| Geisinger Hazleton Cancer Center | |
| Hazleton, Pennsylvania, United States, 18201 | |
| Geisinger Medical Group - Scenery Park | |
| State College, Pennsylvania, United States, 16801 | |
| Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | |
| Wilkes-Barre, Pennsylvania, United States, 18711 | |
| United States, South Carolina | |
| AnMed Cancer Center | |
| Anderson, South Carolina, United States, 29621 | |
| Bon Secours St. Francis Health System | |
| Greenville, South Carolina, United States, 29601 | |
| Carolina Blood and Cancer Care Associates, PA | |
| Lancaster, South Carolina, United States, 29720 | |
| Carolina Blood and Cancer Care | |
| Rock Hill, South Carolina, United States, 29732 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, South Dakota | |
| Avera Cancer Institute | |
| Sioux Falls, South Dakota, United States, 57105 | |
| Sanford Cancer Center at Sanford USD Medical Center | |
| Sioux Falls, South Dakota, United States, 57117-5039 | |
| United States, Virginia | |
| Fredericksburg Oncology, Incorporated | |
| Fredericksburg, Virginia, United States, 22401 | |
| United States, Washington | |
| Northwest Cancer Specialists at Vancouver Cancer Center | |
| Vancouver, Washington, United States, 98684 | |
| Southwest Washington Medical Center Cancer Center | |
| Vancouver, Washington, United States, 98664 | |
| United States, Wisconsin | |
| St. Mary's Hospital Medical Center - Green Bay | |
| Green Bay, Wisconsin, United States, 54303 | |
| Green Bay Oncology, Limited at St. Mary's Hospital | |
| Green Bay, Wisconsin, United States, 54303 | |
| Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | |
| Green Bay, Wisconsin, United States, 54301-3526 | |
| St. Vincent Hospital Regional Cancer Center | |
| Green Bay, Wisconsin, United States, 54307-3508 | |
| Franciscan Skemp Healthcare - La Crosse Campus | |
| La Crosse, Wisconsin, United States, 54601 | |
| Holy Family Memorial Medical Center Cancer Care Center | |
| Manitowoc, Wisconsin, United States, 54221-1450 | |
| Bay Area Cancer Care Center at Bay Area Medical Center | |
| Marinette, Wisconsin, United States, 54143 | |
| Green Bay Oncology, Limited - Oconto Falls | |
| Oconto Falls, Wisconsin, United States, 54154 | |
| St. Nicholas Hospital | |
| Sheboygan, Wisconsin, United States, 53081 | |
| Green Bay Oncology, Limited - Sturgeon Bay | |
| Sturgeon Bay, Wisconsin, United States, 54235 | |
| United States, Wyoming | |
| Rocky Mountain Oncology | |
| Casper, Wyoming, United States, 82609 | |
| Welch Cancer Center at Sheridan Memorial Hospital | |
| Sheridan, Wyoming, United States, 82801 | |
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
| Principal Investigator: | Debra Barton, RN, PhD, AOCN, FAAN | Mayo Clinic |
More Information
Additional Information:
No publications provided
| Responsible Party: | Jan C. Buckner, North Central Cancer Treatment Group |
| ClinicalTrials.gov Identifier: | NCT01376349 History of Changes |
| Other Study ID Numbers: | CDR0000702003, NCCTG-N10C1 |
| Study First Received: | June 17, 2011 |
| Last Updated: | February 24, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Cancer Institute (NCI):
|
depression anxiety disorder cognitive/functional effects sexual dysfunction cancer survivor breast cancer cervical cancer fallopian tube cancer uterine sarcoma |
vaginal cancer vulvar cancer ovarian epithelial cancer ovarian germ cell tumor ovarian sarcoma ovarian stromal cancer primary peritoneal cavity cancer endometrial cancer |
Additional relevant MeSH terms:
|
Dehydroepiandrosterone Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013