Ovarian Cancer Clinical Trial

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

Summary

Researchers are doing this study to look at whether sexual health counselling and using non-hormonal moisturizer at the start of ovarian suppression may be able to prevent or reduce side effects such as vaginal dryness and sexual dysfunction. Researchers will compare how effective this prevention intervention works compared to the usual approach, which is to treat these side effects after they start. All participants will also complete surveys about their sexual health. This information will help researchers learn more about the sexual health of women with breast cancer receiving ovarian suppression.

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Full Description

50 premenopausal or perimenopausal women who are receiving ovarian suppression as part of their breast cancer treatment will be randomized to upfront intervention vs at the time of symptom development (standard of care). Patients will have subjective and objective monitoring of vaginal dryness and sexual dysfunction.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Breast cancer patients with hormone receptor positive breast cancer , stage 0-III
Patients are being initiated on ovarian suppression and endocrine therapy or are within 2 weeks of initiation
Women, 18 years of age or older
Premenopausal or perimenopausal women who have either been pregnant or had at least one menstrual period in the last 24 months or have/had an IUD in place

Exclusion Criteria:

Postmenopausal women who have been without a period for ≥ 2 years
Not initiated on both ovarian suppression and endocrine therapy
Patients who have urogenital symptoms or vaginal dryness at baseline as reported by baseline questionnaires (VAS, VuAS, PROMIS, etc.)

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

50

Study ID:

NCT05910294

Recruitment Status:

Recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

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There are 7 Locations for this study

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Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge New Jersey, 07920, United States More Info
Shari Goldfarb, MD
Contact
646-888-5080
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown New Jersey, 07748, United States More Info
Shari Goldfarb, MD
Contact
646-888-5080
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale New Jersey, 07645, United States More Info
Shari Goldfarb, MD
Contact
646-888-5080
Memorial Sloan Kettering Cancer Center - Suffolk (Limited Protocol Activities)
Commack New York, 11725, United States More Info
Shari Goldfarb, MD
Contact
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison New York, 10604, United States More Info
Shari Goldfarb, MD
Contact
646-888-5080
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Shari Goldfarb, MD
Contact
646-888-5080
Jeanne Carter, PhD
Contact
646-888-5076
Shari Goldfarb, MD
Principal Investigator
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale New York, 11553, United States More Info
Shari Goldfarb, MD
Contact
646-888-5080

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

50

Study ID:

NCT05910294

Recruitment Status:

Recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

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