Health Condition 1: C52- Malignant neoplasm of vagina
Conditions
Interventions
Intervention1: Arm 1: Long-duration vaginal dilator therapy, 10-15 minutes, 3 times per week, optional estrogen
Control Intervention1: Arm 2: Short-duration vaginal dilator therapy, 1-3 minutes, 3 tim
Sponsors
Tata Memorial Centre Research Administrative Council (TRAC)
Eligibility
Inclusion criteria
Inclusion criteria: Women aged 18 70 years with primary, biopsy-confirmed carcinoma of the uterine cervix. FIGO (International Federation of Gynecology and Obstetrics) stage IB IVA. Patients who have received radiotherapy, either as part of their primary treatment or in the adjuvant setting. Willing to participate in the study.
Exclusion criteria
Exclusion criteria: Prior radiotherapy for any cancer other than cervical cancer. Contraindications to estrogen therapy, including: oRecent myocardial infarction. oSevere arterial hypertension. oRefractory diabetes mellitus. oHistory of thromboembolism. oDecompensated liver disease. oHistory of breast cancer or mammary dysplasia with atypical hyperplasia. oFamily history of breast cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vulvovaginal dimensions: Timepoint: The dimensions will be measured of both the arms initally at the Baseline, 3months, 6 months folow up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Compliance and Patient-Reported OutcomesTimepoint: Both the arms will be analysed after the intervention about the comliance rate. Arms will be Compare against changes in sexual function, comfort, and quality of life using scores from the EORTC QLQ-CX24 at baseline, 3 months, and 6 months. | — |
Countries
India
Contacts
Public ContactDr Upasana Baruah
Dr. B Borooah Cancer Institute
Outcome results
None listed