Preventing Sexual Dysfunction With Aromatase Inhibitors
This study is currently recruiting participants.
Verified May 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Collaborators:
Fidia Farmaceutici s.p.a.
Laclede Inc. Healthcare Products
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01603303
First received: May 17, 2012
Last updated: May 21, 2013
Last verified: May 2013
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Purpose
Aromatase inhibitors (AIs) are used to try to stop breast cancer from forming or returning after treatment in women who are in menopause and who had breast cancer that was sensitive to the hormone estrogen.
The goal of this study is to learn if it is possible to prevent some AI side effects, particularly problems with vaginal dryness and pain during sexual activity. Researchers also want to compare 2 new vaginal moisturizers to see if using them regularly helps women avoid vaginal dryness. Researchers want to see if preventing these side effects will decrease the number of women who stop taking AIs due to the side effects they cause.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Behavioral: Questionnaires Other: Education Materials Other: Luvena Other: Hyalo-Gyn Other: Vaginal Lubricant Behavioral: Interactive Internet-Based Website Behavioral: Telephone Counseling. |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Preventing Sexual Dysfunction in Women on Aromatase Inhibitors |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Sexual Dysfunction Rate Reduction [ Time Frame: 12 months ] [ Designated as safety issue: No ]The primary outcome measure will be the total score from the Female Sexual Function Index (FSFI), which is calculated according to a standard scoring algorithm and has a well-validated cut-off score of 26.55 or below indicating sexual dysfunction. FSFI subscale scores will also be calculated and analyzed.
| Estimated Enrollment: | 472 |
| Study Start Date: | December 2012 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Usual Care + Education Materials
Completion of 8 or 9 brief questionnaires at start of study and 6 and 12 months afterwards. Questionnaires should take about 45 to 50 minutes to fill out each time. Participants receive written handout about ways to keep bones stronger during treatment with Aromatase Inhibitors (AIs) and ways to prevent AI side effects such as muscle aches, stiffness, sexual problems, and hot flashes. Water-based vaginal lubricant used during sexual activity.
|
Behavioral: Questionnaires
Completion of 8 or 9 brief questionnaires at start of study and 6 and 12 months afterwards. Questionnaires should take about 45 to 50 minutes to fill out each time.
Other Name: Surveys
Other: Education Materials
Participants receive written handout about ways to keep bones stronger during treatment with Aromatase Inhibitors (AIs) and ways to prevent AI side effects such as muscle aches, stiffness, sexual problems, and hot flashes.
Other Name: Pamphlets
|
|
Experimental: Luvena Group
Luvena used vaginally 2 or 3 times a week. Completion of 8 or 9 brief questionnaires at start of study and 6 and 12 months afterwards. Questionnaires should take about 45 to 50 minutes to fill out each time. Participants receive written handout about ways to keep bones stronger during treatment with Aromatase Inhibitors (AIs) and ways to prevent AI side effects such as muscle aches, stiffness, sexual problems, and hot flashes. Participants use an interactive, internet-based website called Tendrils: Sexual Renewal after Cancer before, during and after treatment with AIs. Telephone counseling for up to 30 minutes in weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. The counselor will follow a manualized program and some sessions will be recorded.
|
Behavioral: Questionnaires
Completion of 8 or 9 brief questionnaires at start of study and 6 and 12 months afterwards. Questionnaires should take about 45 to 50 minutes to fill out each time.
Other Name: Surveys
Other: Education Materials
Participants receive written handout about ways to keep bones stronger during treatment with Aromatase Inhibitors (AIs) and ways to prevent AI side effects such as muscle aches, stiffness, sexual problems, and hot flashes.
Other Name: Pamphlets
Other: Luvena
Use vaginally 2 or 3 times a week.
Other: Vaginal Lubricant
Water-based vaginal lubricant used during sexual activity.
Behavioral: Interactive Internet-Based Website
Participants use an interactive, internet-based website called Tendrils: Sexual Renewal after Cancer before, during and after treatment with AIs.
Behavioral: Telephone Counseling.
Telephone counseling for up to 30 minutes in weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. The counselor will follow a manualized program and some sessions will be recorded.
|
|
Experimental: Hyalo-Gyn Group
Hyalo-Gyn used vaginally 2 - 3 times a week. Completion of 8 or 9 brief questionnaires at start of study and 6 and 12 months afterwards. Questionnaires should take about 45 to 50 minutes to fill out each time. Participants receive written handout about ways to keep bones stronger during treatment with Aromatase Inhibitors (AIs) and ways to prevent AI side effects such as muscle aches, stiffness, sexual problems, and hot flashes. Participants use an interactive, internet-based website called Tendrils: Sexual Renewal after Cancer before, during and after treatment with AIs. Telephone counseling for up to 30 minutes in weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. The counselor will follow a manualized program and some sessions will be recorded.
|
Behavioral: Questionnaires
Completion of 8 or 9 brief questionnaires at start of study and 6 and 12 months afterwards. Questionnaires should take about 45 to 50 minutes to fill out each time.
Other Name: Surveys
Other: Education Materials
Participants receive written handout about ways to keep bones stronger during treatment with Aromatase Inhibitors (AIs) and ways to prevent AI side effects such as muscle aches, stiffness, sexual problems, and hot flashes.
Other Name: Pamphlets
Other: Hyalo-Gyn
Use vaginally 2 - 3 times a week.
Other: Vaginal Lubricant
Water-based vaginal lubricant used during sexual activity.
Behavioral: Interactive Internet-Based Website
Participants use an interactive, internet-based website called Tendrils: Sexual Renewal after Cancer before, during and after treatment with AIs.
Behavioral: Telephone Counseling.
Telephone counseling for up to 30 minutes in weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. The counselor will follow a manualized program and some sessions will be recorded.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of Stage 0 to III breast cancer
- Age over 18 years
- Began adjuvant therapy with an aromatase inhibitor 12 to 18 months before survey sent out (Benchmark Survey only)
- Was prescribed adjuvant therapy with an AI (prior chemotherapy or tamoxifen OK) in past 2 to 4 weeks (Randomized Trial only)
- Had sexual activity at least once in past 12 months (Randomized Trial Study only)
- Has been in a stable sexual relationship of at least 6 months' duration (Randomized Trial study only)
Exclusion Criteria:
- Women using systemic or vaginal estrogen, testosterone, or dehydroepiandrosterone (DHEA) during the Randomized Trial study will be excluded
- Women using systemic or vaginal estrogen, testosterone, or dehydroepiandrosterone (DHEA) in the 12 months preceding the Benchmark Survey Study will be excluded
- Has distant metastases
- Cannot read or speak English well enough to understand materials and complete questionnaires
- No access to the internet in a private location
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603303
Contacts
| Contact: Leslie R. Schover, PHD | 713-745-2681 |
Locations
| United States, Texas | |
| UT MD Andreson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Fidia Farmaceutici s.p.a.
Laclede Inc. Healthcare Products
Investigators
| Principal Investigator: | Leslie R. Schover, PHD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01603303 History of Changes |
| Other Study ID Numbers: | 2012-0125 |
| Study First Received: | May 17, 2012 |
| Last Updated: | May 21, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Breast Cancer Localized breast cancer Postmenopausal women Aromatase inhibitor AI Questionnaires |
Surveys Luvena Internet based website Phone counseling Water-based vaginal lubricant Hyalo-Gyn |
Additional relevant MeSH terms:
|
Breast Neoplasms Sexual Dysfunctions, Psychological Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Sexual and Gender Disorders Mental Disorders Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013