GSM (Genitourinary Syndrome Of Menopause) Management In Breast Cancer Survivors

Study Overview
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Brief Summary
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The impact of treatment for GSM on the quality of life will be examined for postmenopausal women (defined as last menstrual period > 1 year ago or 6 months ago with FSH >40) who have been diagnosed with breast cancer.

Detailed Description
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Postmenopausal breast cancer survivors who report at least one GSM sign or symptom will be offered participation in an observational, prospective open label trial. Study duration will be 6 months. Evidence of GSM symptoms will be evaluated by a board certified gynecologist. Upon satisfying the prescreen requirements, the patient's information will be forwarded to the sub-investigator, who will confirm study eligibility and make the final determination verifying the diagnosis of GSM. Participants will be using commercially available Replens applied via prefilled applicator into the vagina and coconut oil applied at the vaginal introitus and vulva. Both are to be administered by the patient 2 times per week, interval between dosing to be approximately 2 days. Patients will be encouraged to apply Preseed, coconut oil, or patient's personal lubricant of choice into the vagina prior to sexual activity. Patients will record dosing on the Intake Diary. Outcome measures will include: Quality of Life DIVA (Day-to-Day Impact of Vaginal Aging) questionnaire will be administered at Baseline, at month 1, 3 and month 6. The FSFI (Female Sexual Function Index) questionnaire will also be used for sexually active patients at the same time points. This is an exploratory investigation. A planned paired T test will be applied to analyze the outcome and regroup after data has been collected on the first 14 patients.

Official Title
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GSM (Genitourinary Syndrome Of Menopause) Management In Breast Cancer Survivors

Conditions
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Genitourinary Abnormality, Breast Cancer Female, Vaginal Abnormality, Urinary Tract Infections, Dyspareunia, Dysuria

Intervention / Treatment
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* Combination Product: Replens and coconut oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Postmenopausal women (defined as last menstrual period > 1 year ago or 6 months ago with FSH >40) who have been diagnosed with breast cancer including in situ carcinoma (DCIS, LCIS) Have self-identified GSM signs and objective symptoms on baseline screening Patients already using Replens™ or coconut oil will have a two week washout period prior to starting study treatment. Medical History review and Pelvic Exam by a board certified gynecologist for baseline assessment OR medical records review by a board certified gynecologist or delegated study staff to confirm diagnosis of GSM. If GSM is to be verified by medical record review, the sub-investigator will make the final determination of eligibility. Exclusion Criteria: Use of any estrogen containing product within 4 weeks prior to screening Endometrial hyperplasia, endometrial cancer, or other gynecologic malignancy Patients with non GSM related signs and symptoms as verified by a board certified gynecologist will be excluded. Any concurrent illness or disorder that, per the opinion of the investigator, would preclude the patient from meeting the study requirements.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Observational, prospective open label trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Replens and coconut oil<br>Commercially available Replens applied via prefilled applicator into the vagina and coconut oil applied at the vaginal introitus and vulva. Both are to be administered by the patient 2 times per week, interval between dosing to be approximately 2 days. Patients will be encouraged to apply Preseed, coconut oil, or patient's personal lubricant of choice into the vagina prior to sexual activity. | Combination Product: Replens and coconut oil<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of GSM signs and/or symptoms | To show improvement of GSM signs and/or symptoms at month 1 compared to baseline period of administration of the study intervention. This will be measured by administering the Quality of Life DIVA (Day-to-Day Impact of Vaginal Aging) questionnaire. | 1 month | 
| Improvement of GSM signs and/or symptoms | To show improvement of GSM signs and/or symptoms at month 3 compared to baseline period of administration of the study intervention. This will be measured by administering the Quality of Life DIVA (Day-to-Day Impact of Vaginal Aging) questionnaire. | 3 months | 
| Improvement of GSM signs and/or symptoms | To show improvement of GSM signs and/or symptoms at month 6 compared to baseline period of administration of the study intervention. This will be measured by administering the Quality of Life DIVA (Day-to-Day Impact of Vaginal Aging) questionnaire. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual health of breast cancer survivors who are sexually active who are enrolled in this study | This study will investigate the sexual health of breast cancer survivors who are sexually active and using Replens™, Preseed™, coconut oil, or the patient's personal lubricant of choice prior to intercourse by the FSFI (Female Sexual Function Index) questionnaire. The percent change, from baseline to 6 months, in painful sexual activity will be explored. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer survivor, postmenopausal, dysuria, dyspareunia, vaginal dryness, urinary tract infections, urinary frequency, urinary urgency, genital burning, genital itching, genital dryness