Preventing Sexual Dysfunction With Aromatase Inhibitors

NCT01603303 | Completed Phase 2

• 2 other identifiers: 2012-0125NCI-2014-02451
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Localized breast cancer; Postmenopausal women; Aromatase inhibitor; AI; Questionnaires; Surveys; Luvena; Internet based website; Phone counseling; Water-based vaginal lubricant; Hyalo-Gyn

Outcome Measures

Primary Outcomes (1)

• Sexual Dysfunction Rate Reduction

  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.

  12 months

Study Arms (3)

Usual Care + Education Materials

OTHER

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; Other: Education Materials

Luvena Group

EXPERIMENTAL

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; Other: Education Materials; Other: Luvena; Other: Vaginal Lubricant; Behavioral: Interactive Internet-Based Website; Behavioral: Telephone Counseling.

Hyalo-Gyn Group

EXPERIMENTAL

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; Other: Education Materials; Other: Hyalo-Gyn; Other: Vaginal Lubricant; Behavioral: Interactive Internet-Based Website; Behavioral: Telephone Counseling.

Interventions

Questionnaires BEHAVIORAL

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.

Also known as: Surveys

Hyalo-Gyn Group; Luvena Group; Usual Care + Education Materials

Education Materials OTHER

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.

Also known as: Pamphlets

Hyalo-Gyn Group; Luvena Group; Usual Care + Education Materials

Luvena OTHER

Use vaginally 2 or 3 times a week.

Luvena Group

Hyalo-Gyn OTHER

Use vaginally 2 - 3 times a week.

Hyalo-Gyn Group

Vaginal Lubricant OTHER

Water-based vaginal lubricant used during sexual activity.

Hyalo-Gyn Group; Luvena Group

Interactive Internet-Based Website BEHAVIORAL

Participants use an interactive, internet-based website called Tendrils: Sexual Renewal after Cancer before, during and after treatment with AIs.

Hyalo-Gyn Group; Luvena Group

Telephone Counseling. BEHAVIORAL

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.

Hyalo-Gyn Group; Luvena Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Fidia Farmaceutici s.p.a.: collaborator
• Laclede, Inc.: collaborator
• Duncan Family Institute Seed Money Grant: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Abenaa M. Brewster, MD, MHS, BS

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2012
• First Posted: May 22, 2012
• Study Start: December 5, 2012
• Primary Completion: August 11, 2017
• Study Completion: August 11, 2017
• Last Updated: August 18, 2017

Record last verified: 2017-08

Locations

US (1)