Clinical Trials Logo
  1. Home
  2. Other
  3. NCT03185169

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

Breast Cancer Female Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03185169
Study type Interventional
Source Alta Bates Summit Medical Center
Contact
Status Terminated
Phase Early Phase 1
Start date November 18, 2016
Completion date July 23, 2018
View Details
See also
  Status Clinical Trial Phase
Completed NCT03080623 - Ultrasound-based Diagnostic Model for Differentiating Malignant Breast Lesion From Benign Lesion
Completed NCT05527769 - Pain and Functional Recovery After Mastectomy and IBR by Implant: Prepectoral Versus Subpectoral Technique
Completed NCT06376578 - Exercise Interventions for Improving Health in Breast Cancer Survivors N/A
Completed NCT03004534 - A Study to Evaluate Changes in Human Breast Cancer Tissue Following Short-Term Use of Darolutamide Early Phase 1
Recruiting NCT05020574 - Microbiome and Association With Implant Infections Phase 2
Active, not recruiting NCT06277141 - The Vitality Mammography Messaging Study N/A
Completed NCT03555227 - USG PECS vs LIA for Breast Cancer Surgery N/A
Completed NCT03270111 - High Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women N/A
Active, not recruiting NCT03917082 - Limited Adjuvant Endocrine Therapy for Low Risk Breast Cancer Phase 2
Recruiting NCT05561842 - Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria (Mobile Health: Technology and Outcomes in Low and Middle-Income Countries)
Completed NCT04554056 - Trial to Compare the Efficacy and Safety Of MW05 and PEG-rhG-CSF Phase 2/Phase 3
Active, not recruiting NCT03127995 - Hypofractionated vs Standard Radiotherapy in Breast Cancer With an Indication for Regional Lymph Node Irradiation About Lymphedema Occurrence N/A
Active, not recruiting NCT02237469 - Prone Breast Radiotherapy Treatment Planning Observational Study
Completed NCT01204125 - Two Regimens of SAR240550/Weekly Paclitaxel and Paclitaxel Alone as Neoadjuvant Therapy in Triple Negative Breast Cancer Patients Phase 2
Recruiting NCT04565054 - Adjuvant Therapy With Abemaciclib + SOC ET vs. SOC ET in Clinical or Genomic High Risk, HR+/HER2- EBC Phase 3
Not yet recruiting NCT06412133 - Conversations in Light and Shadow: Assessing Phototherapy's Impact on Breast Cancer Patients N/A
Recruiting NCT03956641 - Evolution of the Physical Condition in Treated Cancer Patients N/A
Recruiting NCT06087120 - Investigate the Prognostic and Predictive Value of ctDNA During Neoadjuvant Chemotherapy for Breast Cancer.
Recruiting NCT06058936 - Exercises Using Virtual Reality on Cancer Patients N/A
Completed NCT03470935 - Non-interventional Study Evaluating Gynecological Impact of Diagnosis and Treatment of Breast Cancer in Patients Younger