St. John's Wort in Relieving Hot Flashes in Postmenopausal Women With Non-Metastatic Breast Cancer
This study has been completed.
Sponsor:
Wake Forest Cancer Center CCOP Research Base
Collaborator:
Information provided by (Responsible Party):
Wake Forest Cancer Center CCOP Research Base
ClinicalTrials.gov Identifier:
NCT00110136
First received: May 3, 2005
Last updated: April 1, 2013
Last verified: April 2013
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Purpose
RATIONALE: St. John's wort may help relieve hot flashes in women with breast cancer.
PURPOSE: This phase II trial is studying how well St. John's wort works in relieving hot flashes in women with non-metastatic breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Hot Flashes |
Drug: St. John's Wort |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | A Phase II Study of St. John's Wort for the Treatment of Hot Flashes in Women With a History of Breast Cancer |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
St. John's Wort
U.S. FDA Resources
Further study details as provided by Wake Forest Cancer Center CCOP Research Base:
Primary Outcome Measures:
- Effects of St. John's wort on mild to moderate hot flashes as measured by hot flash diary at baseline to 4 weeks [ Time Frame: One year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Changes in hot flash scores and duration by hot flash diary at baseline and weeks 1-6 [ Time Frame: One year ] [ Designated as safety issue: No ]
- Toxicity at screening, baseline, week 2, week 4, and week 6 [ Time Frame: One year ] [ Designated as safety issue: Yes ]
- Effects of St. John's wort on serum tamoxifen levels at screening, baseline, and weeks 2, 4, and 6 [ Time Frame: One year ] [ Designated as safety issue: No ]
- Quality of life by POMS and SF-12 at 2 and 4 weeks relative to baseline and during 2 week post-treatment phase [ Time Frame: One year ] [ Designated as safety issue: No ]
| Enrollment: | 9 |
| Study Start Date: | March 2006 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: St. John's Wort
Patient given one 300mg St. John's Wort tablet three times per day
|
Drug: St. John's Wort
St. John's Wort 300mg tablet three times per day
Other Name: St. John's Wort
|
Detailed Description:
OBJECTIVES:
Primary
- Determine the efficacy of Hypericum perforatum (St. John's wort) in alleviating hot flashes, in terms of hot flash frequency, score, and duration and disruption of daily activities caused by hot flashes, in postmenopausal women with non-metastatic breast cancer.
- Determine hot flash changes over 4 weeks in patients treated with this drug.
Secondary
- Determine the toxicity of this drug in these patients.
- Determine the effect of Hypericum perforatum (St. John's wort) on serum tamoxifen levels in women receiving tamoxifen therapy.
- Determine the effect of Hypericum perforatum (St. John's wort) on general health-related quality of life and mood at 2 and 4 weeks relative to baseline, and during the 2 week post-treatment phase in these patients.
- To evaluate changes in average weekly hot flush scores and duration over course of study.
OUTLINE: This is a multicenter study.
Patients receive oral Hypericum perforatum (St. John's wort) three times daily for 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients complete a daily diary of the frequency, severity, and duration of their hot flashes, and complete quality of life and mood assessments every 2 weeks during study treatment and continuing weekly for 2 weeks after completion of study treatment.
Patients receiving tamoxifen will have blood tests to measure serum tamoxifen levels at baseline, 2, 4, and 6 weeks.
PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
- Noninvasive ductal carcinoma in situ
Localized breast cancer
- Stage 0-IIIB disease
- Locally recurrent breast cancer that is post-treatment AND disease-free for ≥ 2 years
- Experiencing ≥ 3 hot flashes per day (≥ 21 per week), defined by sweating, flushing, sensation of warmth, night sweats, and/or rapid heart beat of sufficient severity that the patient desires therapeutic intervention
- Normal mammogram within the past 10 months
Hormone receptor status:
- Not specified
INCLUSION CRITERIA:
Age
- 18 and over
Sex
- Female
Menopausal status
- Post-menopausal (i.e., no menstrual periods ≥ 12 months or surgical menopause)
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Bilirubin < 2 mg/dL
- SGOT ≤ 2 times normal
Renal
- Not specified
EXCLUSION CRITERIA:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No history of intolerance to St. John's wort
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No concurrent cytotoxic chemotherapy
Endocrine therapy
No concurrent selective estrogen-receptor modulators or aromatase inhibitors (e.g., anastrozole, letrozole, or exemestane) allowed
- Concurrent tamoxifen allowed
- No concurrent estrogen, progestational agents, or androgens for the alleviation of hot flashes
- No concurrent corticosteroids
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- More than 14 days since prior Hypericum perforatum (St. John's wort), monoamine oxidase inhibitors, selective serotonin reuptake inhibitors (e.g., sertraline, paroxetine, or fluoxetine) or selective norepinephrine reuptake inhibitors (e.g., venlafaxine)
No concurrent use of any of the following:
- Antidepressants
- Theophylline
- Warfarin, unless for central line prophylaxis
- Protease inhibitors for AIDS
- Digoxin
- Cyclosporine
- Benzodiazepines (e.g., diazepam or alprazolam)
- Calcium-channel blockers (e.g., diltiazem or nifedipine)
- Coenzyme A reductase inhibitors for serum cholesterol reduction
- Macrolide antibiotics (e.g., azithromycin, erythromycin, or clarithromycin)
- Griseofulvin
- Phenobarbital
- Phenytoin
- Rifampin
- Rifabutin
- Grapefruit juice
- Other naturopathic or herbal products
- Ketoconazole
- Fluconazole
- Itraconazole
- Rifabutin
- No other concurrent medications for the alleviation of hot flashes (e.g., clonidine or bellamine)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00110136
Locations
| United States, Delaware | |
| Helen F. Graham Cancer Center at Christiana Hospital | |
| Newark, Delaware, United States, 19713 | |
| United States, District of Columbia | |
| MBCCOP - Howard University Cancer Center | |
| Washington, District of Columbia, United States, 20060 | |
| United States, Florida | |
| University of Miami Sylvester Comprehensive Cancer Center - Miami | |
| Miami, Florida, United States, 33136 | |
| United States, Illinois | |
| CCOP - Central Illinois | |
| Decatur, Illinois, United States, 62526 | |
| United States, Indiana | |
| CCOP - Northern Indiana CR Consortium | |
| South Bend, Indiana, United States, 46601 | |
| United States, Louisiana | |
| Feist-Weiller Cancer Center at Louisiana State University Health Sciences | |
| Shreveport, Louisiana, United States, 71130-3932 | |
| United States, Michigan | |
| CCOP - Michigan Cancer Research Consortium | |
| Ann Arbor, Michigan, United States, 48106 | |
| CCOP - Beaumont | |
| Royal Oak, Michigan, United States, 48073-6769 | |
| United States, Minnesota | |
| CCOP - Metro-Minnesota | |
| St. Louis Park, Minnesota, United States, 55416 | |
| United States, Missouri | |
| Cancer Research for the Ozarks | |
| Springfield, Missouri, United States, 65804 | |
| CCOP - St. Louis-Cape Girardeau | |
| St. Louis, Missouri, United States, 63141 | |
| United States, North Carolina | |
| Alamance Cancer Center at Alamance Regional Medical Center | |
| Burlington, North Carolina, United States, 27216 | |
| Hugh Chatham Memorial Hospital | |
| Elkin, North Carolina, United States, 28621 | |
| CCOP - Southeast Cancer Control Consortium | |
| Goldsboro, North Carolina, United States, 27534-9479 | |
| Leo W. Jenkins Cancer Center at ECU Medical School | |
| Greenville, North Carolina, United States, 27835-6028 | |
| Wake Forest University Comprehensive Cancer Center | |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| United States, South Carolina | |
| CCOP - Greenville | |
| Greenville, South Carolina, United States, 29615 | |
| South Carolina Cancer Specialists | |
| Hilton Head Island, South Carolina, United States, 29925 | |
| CCOP - Upstate Carolina | |
| Spartanburg, South Carolina, United States, 29303 | |
Sponsors and Collaborators
Wake Forest Cancer Center CCOP Research Base
Investigators
| Study Chair: | Michelle Naughton, PhD | Comprehensive Cancer Center of Wake Forest University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Wake Forest Cancer Center CCOP Research Base |
| ClinicalTrials.gov Identifier: | NCT00110136 History of Changes |
| Other Study ID Numbers: | CCCWFU 98301, U10CA081851 |
| Study First Received: | May 3, 2005 |
| Last Updated: | April 1, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Wake Forest Cancer Center CCOP Research Base:
|
recurrent breast cancer stage I breast cancer stage II breast cancer stage IIIA breast cancer |
stage IIIB breast cancer breast cancer in situ ductal breast carcinoma in situ hot flashes |
Additional relevant MeSH terms:
|
Breast Neoplasms Hot Flashes Neoplasms by Site Neoplasms |
Breast Diseases Skin Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013