Preventing Sexual Dysfunction With Aromatase Inhibitors

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborators:
Fidia Farmaceutici s.p.a.
Laclede Inc. Healthcare Products
Duncan Family Institute Seed Money Grant
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01603303
First received: May 17, 2012
Last updated: May 28, 2014
Last verified: May 2014
  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:

  1. Diagnosis of Stage 0 to III breast cancer
  2. Age over 18 years
  3. Began adjuvant therapy with an aromatase inhibitor 12 to 18 months before survey sent out (Benchmark Survey only)
  4. Was prescribed adjuvant therapy with an AI (prior chemotherapy or tamoxifen OK) in past 2 to 4 weeks (Randomized Trial only)
  5. Had sexual activity at least once in past 12 months (Randomized Trial Study only)
  6. Has been in a stable sexual relationship of at least 6 months' duration (Randomized Trial study only)

Exclusion Criteria:

  1. Women using systemic or vaginal estrogen, testosterone, or dehydroepiandrosterone (DHEA) during the Randomized Trial study will be excluded
  2. Women using systemic or vaginal estrogen, testosterone, or dehydroepiandrosterone (DHEA) in the 12 months preceding the Benchmark Survey Study will be excluded
  3. Has distant metastases
  4. Cannot read or speak English well enough to understand materials and complete questionnaires
  5. No access to the internet in a private location
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Duncan Family Institute Seed Money Grant
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 28, 2014
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 July 22, 2014