Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:55 PM
Study NCT ID:
NCT05910294
Status:
RECRUITING
Last Update Posted:
2025-04-01
First Post:
2023-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Prevent and Improve Sexual Health Concerns for People With Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-26', 'studyFirstSubmitDate': '2023-06-01', 'studyFirstSubmitQcDate': '2023-06-09', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with a score of 4 or greater in VAS', 'timeFrame': '1 year', 'description': 'measured by the Vaginal Assessment Scale (VAS)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sexual Health Concerns', 'Prevention', 'Premenopausal', 'Female Breast Cancer Patients', 'Receiving Ovarian Suppression', '23-109'], 'conditions': ['Improve Sexual Health', 'Improve Vulvovaginal Health']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org/mskcc/html/44.cfm', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Breast Cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women, 18 years of age or older\n* Breast cancer patients with hormone receptor positive breast cancer , stage 0-III\n* 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\n* Patients currently on or are being initiated on ovarian suppression\n* 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\n\nExclusion Criteria:\n\n* Postmenopausal women who have been without a period for ≥ 2 years\n* Patients who score a 4 or above on the VAS and VuAS\n* Patients already using VVA treatment (e.g. intravaginal estrogen, other non-hormonal moisturizer or suppository), unless discontinued with washout of 4 weeks'}, 'identificationModule': {'nctId': 'NCT05910294', 'briefTitle': 'A Study to Prevent and Improve Sexual Health Concerns for People With Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Randomized Pilot Prevention Trial to Improve Sexual and Vulvovaginal Health Concerns in Premenopausal Female Breast Cancer Patients Receiving Ovarian Suppression', 'orgStudyIdInfo': {'id': '23-109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'symptom onset', 'description': "Symptom onset 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.", 'interventionNames': ['Other: questionnaires', 'Other: moisturizers']}, {'type': 'EXPERIMENTAL', 'label': 'intervention', 'description': '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.', 'interventionNames': ['Other: questionnaires', 'Other: moisturizers']}], 'interventions': [{'name': 'questionnaires', 'type': 'OTHER', 'description': 'Vaginal Assessment Scale (VAS) \\& Vulvar Assessment Scale (VuAS) Breast Clinical Care and Symptom Survey (BCCSS) 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', 'armGroupLabels': ['intervention', 'symptom onset']}, {'name': 'moisturizers', 'type': 'OTHER', '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.", 'armGroupLabels': ['symptom onset']}, {'name': 'moisturizers', 'type': 'OTHER', 'description': 'potential vaginal moisturizers include Hyalogyn, Replens, Liquibeads, or Vitamin E capsules', 'armGroupLabels': ['intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shari Goldfarb, MD', 'role': 'CONTACT', 'phone': '646-888-5080'}], 'facility': 'Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}, {'zip': '07748', 'city': 'Middletown', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shari Goldfarb, MD', 'role': 'CONTACT', 'phone': '646-888-5080'}], 'facility': 'Memorial Sloan Kettering Monmouth (Limited Protocol Activities)', 'geoPoint': {'lat': 40.39428, 'lon': -74.11709}}, {'zip': '07645', 'city': 'Montvale', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shari Goldfarb, MD', 'role': 'CONTACT', 'phone': '646-888-5080'}], 'facility': 'Memorial Sloan Kettering Bergen (Limited Protocol Activities)', 'geoPoint': {'lat': 41.04676, 'lon': -74.02292}}, {'zip': '11725', 'city': 'Commack', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shari Goldfarb, MD', 'role': 'CONTACT'}], 'facility': 'Memorial Sloan Kettering Cancer Center - Suffolk (Limited Protocol Activities)', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '10604', 'city': 'Harrison', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shari Goldfarb, MD', 'role': 'CONTACT', 'phone': '646-888-5080'}], 'facility': 'Memorial Sloan Kettering Westchester (Limited Protocol Activities)', 'geoPoint': {'lat': 40.96899, 'lon': -73.71263}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shari Goldfarb, MD', 'role': 'CONTACT', 'phone': '646-888-5080'}, {'name': 'Jeanne Carter, PhD', 'role': 'CONTACT', 'phone': '646-888-5076'}, {'name': 'Shari Goldfarb, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11553', 'city': 'Uniondale', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shari Goldfarb, MD', 'role': 'CONTACT', 'phone': '646-888-5080'}], 'facility': 'Memorial Sloan Kettering Nassau (Limited Protocol Activities)', 'geoPoint': {'lat': 40.70038, 'lon': -73.59291}}], 'centralContacts': [{'name': 'Shari Goldfarb, MD', 'role': 'CONTACT', 'email': 'goldfars@mskcc.org', 'phone': '646-888-5080'}, {'name': 'Jeanne Carter, PhD', 'role': 'CONTACT', 'phone': '646-888-5076'}], 'overallOfficials': [{'name': 'Shari Goldfarb, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}