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Sexual Health Support for Breast Cancer

N/A

Recruiting

Led By Shari Goldfarb, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Breast cancer patients with hormone receptor positive breast cancer, stage 0-III

Be older than 18 years old

Must not have

Not initiated on both ovarian suppression and endocrine therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if counseling and moisturizer can help reduce sexual side effects in women with breast cancer. Participants will report on their sexual health for further understanding.

Who is the study for?

This trial is for premenopausal or perimenopausal women with hormone receptor positive breast cancer stages 0-III, who are starting ovarian suppression and endocrine therapy. They must be at least 18 years old and have had a menstrual period or been pregnant in the last two years, or have/had an IUD.

What is being tested?

The study tests if sexual health counseling and using non-hormonal moisturizers from the start of ovarian suppression can prevent or reduce vaginal dryness and sexual dysfunction compared to treating these issues after they arise. Participants will also fill out surveys about their sexual health.

What are the potential side effects?

There may not be direct side effects from the interventions since they involve questionnaires and non-hormonal moisturizers. However, participants might experience discomfort discussing personal topics during counseling sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My breast cancer is hormone receptor positive and is stage 0 to III.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have not started both ovarian suppression and hormone therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with a score of 5 or greater in VAS

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: interventionExperimental Treatment2 Interventions

Patients who are randomized to the upfront arm will receive sexual health counseling and be initiated on non-hormonal moisturizers 3-5 times per week (based on data regarding need in our patient population) at the time ovarian suppression. The upfront intervention group will also be educated about dilators and have a consultation with a pelvic floor physical therapist. Some potential vaginal moisturizers include Hyalogyn, Replens, Liquibeads, or Vitamin E capsules.

Group II: standard of careActive Control2 Interventions

Standard of care arm will receive treatment at the time symptoms develop. Patients will be provided a list of recommended moisturizers by the female sexual medicine and women's health program (FSMWHP), but will purchase the moisturizers themselves at their local pharmacy.

0 / 2Eligibility criteria met