Trial Title:
A Study to Prevent and Improve Sexual Health Concerns for People With Breast Cancer
NCT ID:
NCT05910294
Condition:
Improve Sexual Health
Improve Vulvovaginal Health
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Sexual Health Concerns
Prevention
Premenopausal
Female Breast Cancer Patients
Receiving Ovarian Suppression
23-109
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
questionnaires
Description:
Vaginal Assessment Scale (VAS) & Vulvar Assessment Scale (VuAS) Breast survivorship Tool
(MSK Engage Symptom Assessment) Female Sexual Function Index (FSFI) Sexual Activity
Questionnaire (SAQ) Female Sexual Distress Scale Revised (FSDS-R) Menopausal Symptom
Check List (MSCL) Patient-reported Outcomes Measurement Information System Sexual
Function Instrument (PROMIS-SF) Weekly Non-Hormonal Moisturizer Diary
Arm group label:
intervention
Arm group label:
standard of care
Intervention type:
Other
Intervention name:
moisturizers
Description:
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.
Arm group label:
standard of care
Intervention type:
Other
Intervention name:
moisturizers
Description:
potential vaginal moisturizers include Hyalogyn, Replens, Liquibeads, or Vitamin E
capsules
Arm group label:
intervention
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.
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.
Criteria for 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 score above a 4 for urogenital symptoms or vaginal dryness at baseline
as reported by baseline questionnaires (VAS and VuAS)
Gender:
Female
Gender based:
Yes
Gender description:
Breast Cancer
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shari Goldfarb, MD
Phone:
646-888-5080
Facility:
Name:
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shari Goldfarb, MD
Phone:
646-888-5080
Facility:
Name:
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shari Goldfarb, MD
Phone:
646-888-5080
Facility:
Name:
Memorial Sloan Kettering Cancer Center - Suffolk (Limited Protocol Activities)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shari Goldfarb, MD
Facility:
Name:
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shari Goldfarb, MD
Phone:
646-888-5080
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shari Goldfarb, MD
Phone:
646-888-5080
Contact backup:
Last name:
Jeanne Carter, PhD
Phone:
646-888-5076
Investigator:
Last name:
Shari Goldfarb, MD
Email:
Principal Investigator
Facility:
Name:
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shari Goldfarb, MD
Phone:
646-888-5080
Start date:
June 1, 2023
Completion date:
June 2027
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05910294
http://www.mskcc.org/mskcc/html/44.cfm
