| CTRI Number |
CTRI/2026/02/104217 [Registered on: 18/02/2026] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Helping Women Recover Vaginal Comfort and Flexibility After Cervical Cancer Radiation: Does Using a Vaginal Dilator for a Longer Time Work Better |
|
Scientific Title of Study
|
Rehabilitation and Enhancement of Vulvovaginal Integrity and Elasticity after Radiation Therapy in Cervical cancer Effect of long and short term application of vaginal dilators on Vulvovaginal Dimensions |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Upasana Baruah |
| Designation |
Professor Dept Gynaecological Oncology |
| Affiliation |
Dr. B Borooah Cancer Institute |
| Address |
Room no 17 Ground Floor OPD Building Dr Bhubaneswar Borooah Cancer Institute Guwahati
Room no 17 Ground Floor OPD Building Dr Bhubaneswar Borooah Cancer Institute Guwahati
Kamrup
ASSAM
781016
India |
| Phone |
8812828202 |
| Fax |
- |
| Email |
drupasanbaruah@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Upasana Baruah |
| Designation |
Professor Dept Gynaecological Oncology |
| Affiliation |
Dr. B Borooah Cancer Institute |
| Address |
Room no 17 Ground Floor OPD Building Dr Bhubaneswar Borooah Cancer Institute Guwahati
Room no 17 Ground Floor OPD Building Dr Bhubaneswar Borooah Cancer Institute Guwahati
ASSAM
781016
India |
| Phone |
8812828202 |
| Fax |
- |
| Email |
drupasanbaruah@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Upasana Baruah |
| Designation |
Professor Dept Gynaecological Oncology |
| Affiliation |
Dr. B Borooah Cancer Institute |
| Address |
Room no 17 Ground Floor OPD Building Dr Bhubaneswar Borooah Cancer Institute Guwahati
Room no 17 Ground Floor OPD Building Dr Bhubaneswar Borooah Cancer Institute Guwahati
ASSAM
781016
India |
| Phone |
8812828202 |
| Fax |
- |
| Email |
drupasanbaruah@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Centre Research Administrative Council (TRAC), 3rd Floor Clinical Research Secretariat Department Service Block building Tata Memorial Hospital Parel Mumbai Maharashtra India 400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre Research Administrative Council (TRAC) |
| Address |
Clinical Research Secretariat, 3rd floor Service building, Tata Memorial Hospital, Dr. Ernest Borges Road, Parel, Mumbai 400012. |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Upasana Baruah |
Dr Bhubaneswar Borooah Cancer Insitute |
Room No 17 Ground Floor OPD Building Dr. Bhubaneswar Borooah Cancer Institute
Kamrup
ASSAM |
8812828202
-
drupasanabaruah@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medical Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C52||Malignant neoplasm of vagina, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arm 1 |
Long-duration vaginal dilator therapy, 10-15 minutes, 3 times per week, optional estrogen |
| Comparator Agent |
Arm 2 |
Short-duration vaginal dilator therapy, 1-3 minutes, 3 times per week, optional estrogen |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Vulvovaginal dimensions:
|
The dimensions will be measured of both the arms initally at the Baseline, 3months, 6 months folow up. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compliance and Patient-Reported Outcomes |
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. |
|
|
Target Sample Size
|
Total Sample Size="166"
Sample Size from India="166"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Women with cervical cancer are often treated with radiation therapy (with or without chemotherapy). While this treatment improves survival, it can cause long-term side effects in the vagina. Radiation can lead to scarring, narrowing, dryness, and loss of elasticity of the vaginal canal. This condition, called vaginal stenosis, can cause discomfort, pain during sexual activity, emotional distress, and reduced quality of life.
To help prevent these problems, doctors often recommend using a vaginal dilator. A vaginal dilator is a smooth, tube-shaped medical device that is gently inserted into the vagina several times a week. It helps keep the vaginal canal open and flexible by stretching the tissues and preventing scarring from sticking together. Some women are also advised to use a topical estrogen cream to reduce dryness and improve comfort.
However, there is no clear agreement on how long each dilator session should last. Some guidelines recommend 10–15 minutes per session, while others suggest shorter durations. Longer sessions may be difficult for many women to continue regularly, especially in India, where awareness and comfort discussing sexual health can be limited. Because of this, many women may not follow the treatment as advised.
The REVIVE-C Trial is being conducted at the Department of Gynaecologic Oncology, Dr B Borooah Cancer Institute, to compare two different durations of vaginal dilator use in women who have completed radiation therapy for cervical cancer.
The study will include 166 women aged 18 to 70 years who have received radiation for cervical cancer (FIGO stage IB–IVA). Participants will be randomly divided into two groups:
-
Group 1 (Standard Duration): Use the vaginal dilator for 10–15 minutes, three times per week.
-
Group 2 (Short Duration): Use the vaginal dilator for 1–3 minutes, three times per week.
In both groups, women may use estrogen cream if recommended by their doctor.
The treatment will continue for six months. Doctors will measure vaginal length, width, and elasticity at the beginning and end of the study using simple examination tools. Women will also complete a questionnaire called the EORTC QLQ-CX24 to understand how they feel about their sexual health, comfort, and overall quality of life.
The main goal of the study is to find out whether shorter dilator sessions work just as well as longer sessions in maintaining vaginal health. If shorter sessions are equally effective, they may be easier for women to follow, leading to better long-term compliance and improved quality of life.
This study is important because there is limited research in Indian women on managing vaginal side effects after radiation therapy. The results may help develop practical, culturally suitable guidelines for improving the quality of life of cervical cancer survivors in India. |