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NCT05910294 | RECRUITING | Improve Sexual Health

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

Memorial Sloan Kettering Cancer Center

Brief 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.

Condition or disease

Improve Sexual Health

Improve Vulvovaginal Health

Intervention/treatment

questionnaires

moisturizers

moisturizers

Phase

NA

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 50 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : Randomized Pilot Prevention Trial to Improve Sexual and Vulvovaginal Health Concerns in Premenopausal Female Breast Cancer Patients Receiving Ovarian Suppression
Actual Study Start Date : 2023-06-01
Estimated Primary Completion Date : 2027-06
Estimated Study Completion Date : 2027-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Women, 18 years of age or older
  • * Breast cancer patients with hormone receptor positive breast cancer , stage 0-III
  • * 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
  • * Patients currently on or are being initiated on ovarian suppression
  • * Patients are asymptomatic for vaginal symptoms of estrogen deprivation (i.e. vaginal dryness, dyspareunia, or discomfort \[pain with intercourse or examination\]) and score a 3 or less on the VAS and VuAS
Exclusion Criteria
  • * Postmenopausal women who have been without a period for ≥ 2 years
  • * Patients who score a 4 or above on the VAS and VuAS
  • * Patients already using VVA treatment (e.g. intravaginal estrogen, other non-hormonal moisturizer or suppository), unless discontinued with washout of 4 weeks
A Study to Prevent and Improve Sexual Health Concerns for People With Breast Cancer

Location Details

NCT05910294

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States, 07920

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States, 07748

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States, 07645

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center - Suffolk (Limited Protocol Activities)

Commack, New York, United States, 11725

RECRUITING

United States, New York

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States, 10604

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

RECRUITING

United States, New York

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States, 11553