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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with a score of 4 or greater in VAS

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,847 Total Patients Enrolled

Shari Goldfarb, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

8 Previous Clinical Trials

1,418 Total Patients Enrolled

Media Library

Non-hormonal Moisturizer Clinical Trial Eligibility Overview. Trial Name: NCT05910294 — N/A

Sexual Wellness Research Study Groups: standard of care, intervention

Sexual Wellness Clinical Trial 2023: Non-hormonal Moisturizer Highlights & Side Effects. Trial Name: NCT05910294 — N/A

Non-hormonal Moisturizer 2023 Treatment Timeline for Medical Study. Trial Name: NCT05910294 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there numerous locations participating in this clinical investigation within the state?

"Participants may select from 7 distinct medical centres located in Middletown, Montvale and Commack. To minimize the strain of travel-related expenses it is important to enroll at a location near you."

Answered by AI

How many participants are receiving care by way of this clinical trial?

"Affirmative. The details logged on clinicaltrials.gov demonstrate that the medical trial, which was first posted on June 1st 2023, is actively seeking patients. A total of 50 participants are required to be recruited from 7 different locations."

Answered by AI

Is the enrollment period still open for this experimental research?

"Clinicaltrials.gov is exhibiting that this clinical trial, first activated on the 1st of June 2023, is still recruiting participants. The latest update was recorded as being on the 9th of June 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Prevent and Improve Sexual Health Concerns for People With Breast Cancer

2023. "A Study to Prevent and Improve Sexual Health Concerns for People With Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05910294.