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CTRI Number  CTRI/2024/04/065455 [Registered on: 09/04/2024] Trial Registered Prospectively
Last Modified On: 05/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Radiation Therapy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to see the effect of using a steroid cream on the skin of the breast during radiation therapy to the whole breast in preventing radiation induced skin reactions in breast cancer patients undergoing breast conservative treatment. 
Scientific Title of Study   Topical corticosteroid in prevention of radiation dermatitis in breast cancer patients undergoing breast conservative treatment - an intrapatient randomized controlled trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
JIP/IEC/2024/01/15 Version 1.0 Date: 12/03/24  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Adapa Bindu Sai Sree 
Designation  Junior Resident 
Affiliation  JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH 
Address  Department of Radiation Oncology Regional Cancer Centre, JIPMER, Dhanvantari Nagar, Gorimedu, Puducherry.

Pondicherry
PONDICHERRY
605006
India 
Phone  8639448124  
Fax    
Email  bindureddyadapa@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gunaseelan K  
Designation  Professor 
Affiliation  JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH 
Address  Department of Radiation Oncology Regional Cancer Centre, JIPMER, Dhanvantari Nagar, Gorimedu, Puducherry.

Pondicherry
PONDICHERRY
605006
India 
Phone  9362966444  
Fax    
Email  gunapgi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gunaseelan K  
Designation  Professor 
Affiliation  JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH 
Address  Department of Radiation Oncology Regional Cancer Centre, JIPMER, Dhanvantari Nagar, Gorimedu, Puducherry.


PONDICHERRY
605006
India 
Phone  9362966444  
Fax    
Email  gunapgi@gmail.com  
 
Source of Monetary or Material Support  
Intramural Research Fund, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Dhanvantari Nagar, Gorimedu, Puducherry, 605006. 
 
Primary Sponsor  
Name  Dr Adapa Bindu Sai Sree 
Address  Department of Radiation Oncology, Regional Cancer Centre,JIPMER Puducherry - 605006  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Adapa Bindu Sai Sree  Regional cancer centre,Jawaharlal Institute of Postgraduate Medical Education and Research  Department of Radiation Oncology, Regional Cancer Centre RCC, JIPMER, Dhanvantari Nagar, Gorimedu, Pondicherry, 605006.
Pondicherry
PONDICHERRY 		 8639448124

bindureddyadapa@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JIPMER Institutional Ethics Committee Interventional Studies  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C502||Malignant neoplasm of upper-innerquadrant of breast, (2) ICD-10 Condition: C503||Malignant neoplasm of lower-innerquadrant of breast, (3) ICD-10 Condition: C504||Malignant neoplasm of upper-outerquadrant of breast, (4) ICD-10 Condition: C505||Malignant neoplasm of lower-outerquadrant of breast, (5) ICD-10 Condition: C501||Malignant neoplasm of central portion of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Bare skin in other half of the breast  Patients with breast cancer receiving hypofractionated whole breast irradiation with simultaneous integrated boost using volumetric modulated arc therapy technique 
Intervention  Topical corticosteroid in half of the breast  Mometasone furoate 0.1% in patients with breast cancer receiving hypofractionated whole breast irradiation with simultaneous integrated boost using volumetric modulated arc therapy technique. Mometasone furoate 0.1% cream will be applied to the appropriate half of treated breast 4 hours before or after radiation therapy once daily during and until the end of radiation therapy. The total duration of radiation therapy is 3 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Female 
Details  1.Above 18 years of age
2.Breast-conservative surgery for breast cancer
3.A hypofractionation regimen of 40.5Gy in 15 fractions (fx) with simultaneous integrated boost technique.
 
 
ExclusionCriteria 
Details  1.Hypersensitivity to mometasone furoate
2.Bilateral breast carcinoma
3.Patients receiving leukotriene inhibitors
4.Patients on steroids for chronic conditions
5.Active dermatitis
6.Any preexisting dermatological disorder
7.Tattoos in the irradiation area
8.Previous radiation to ipsilateral breast
9.Metastatic disease
10.Active smoking status
11.Pre-existing skin breakdown within the planned radiotherapy field at the time of study
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the incidence and time to onset of grade 2 or more radiation dermatitis using CTCAE v5.0 criteria and score 3 or more pain score as assessed by the visual analogue scale (VAS)  weekly,at the last fraction of radiation and 4 weeks post radiation 
 
Secondary Outcome  
Outcome  TimePoints 
To assess skin toxicity on quality of life as measured by Radiation Induced Skin Reactions Assessment score(RISRAS) and Dermatology life quality index questionnaire (DLQI)   weekly,at the last fraction of radiation and 4 weeks post radiation 
 
Target Sample Size   Total Sample Size="43"
Sample Size from India="43" 
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)   18/04/2024 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  
Title of the project is "Topical corticosteroid in prevention of radiation dermatitis in breast cancer patients undergoing breast conservative treatment - an intrapatient randomized controlled trial".
Among breast cancer patients receiving radiation, a wide majority of them(74-100%) report radiation dermatitis. Radiation dermatitis has major consequences on adherence to treatment and quality of life. Though there are many methods for prevention of radiation dermatitis there is no standard treatment as such. One of the method is using topical corticosteroids. They are prescribed because of their ability to counteract the cytokine release caused by radiation.They also induce vasoconstriction,decrease capillary permeability & inhibit leukocyte proliferation and migration.
Mometasone furoate is well tolerated with only transient, mild to moderate local adverse effects. The result in this study will provide clarity and efficacy on using Mometasone furoate steroid cream in reducing radiation dermatitis and local site pain in early breast cancer patients.

 
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