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CTRI Number  CTRI/2024/11/076905 [Registered on: 18/11/2024] Trial Registered Prospectively
Last Modified On: 15/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A Study on Patient-Reported Outcomes for Acute Toxicity in Breast Cancer Patients Undergoing Radiation Therapy and Its Impact on Quality of Life 
Scientific Title of Study   A Prospective Study On Patient Reported Outcomes For Acute Toxicity In Breast Cancer Patients Receiving Radiation Therapy And Its Impact On Quality Of Life 
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 Lucky Kumawat 
Designation  DNB Junior Resident Radiation Oncology 
Affiliation   
Address  Max Super Specialty Hospital W-3, Sector-1, Vaishali, Ghaziabad- 201012. U.P.

Ghaziabad
UTTAR PRADESH
201012
India 
Phone  8200761884  
Fax    
Email  luckykumawat44@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rashi Agrawal 
Designation  Associate Director Radiation Oncology 
Affiliation   
Address  Max Super Specialty Hospital W-3, Sector-1, Vaishali, Ghaziabad- 201012. U.P.

Ghaziabad
UTTAR PRADESH
201012
India 
Phone  9891483550  
Fax    
Email  drrashi.ag@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rashi Agrawal 
Designation  Associate Director Radiation Oncology 
Affiliation   
Address  Max Super Specialty Hospital W-3, Sector-1, Vaishali, Ghaziabad- 201012. U.P.

Ghaziabad
UTTAR PRADESH
201012
India 
Phone  9891483550  
Fax    
Email  drrashi.ag@gmail.com  
 
Source of Monetary or Material Support  
Max Super Specialty Hospital W-3, Sector-1, Vaishali, Ghaziabad- 201012. U.P. 
 
Primary Sponsor  
Name  Dr Lucky Kumawat 
Address  Max Super Specialty Hospital W-3, Sector-1, Vaishali, Ghaziabad- 201012. U.P. 
Type of Sponsor  Research institution and hospital 
 
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 Lucky Kumawat  Max Super Specialty Hospital W-3, Sector-1, Vaishali, Ghaziabad- 201012. U.P.   Department of Radiation Oncology , Tower 1 lower basement
Ghaziabad
UTTAR PRADESH 
8200761884

luckykumawat44@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C50-C50||Malignant neoplasms of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  Age 18 years
Female patients
Biopsy proven invasive breast cancer
Post operative breast cancer patients having standard indication of radiation therapy
Non metastatic  
 
ExclusionCriteria 
Details  Recurrence of disease in ipsilateral or contralateral side
Patients who have previously received radiation therapy to chest  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Base don the findings there might be recommendations for adjusting radiation therapy parameters to improve the balance between treatment efficacy and quality of life preservation   At start of the treatment , at the completion of treatment, 3 months after completion of treatment  
 
Secondary Outcome  
Outcome  TimePoints 
The results will be reviewed via EORTC QLQ-C30, BR23 questionnaire at start of the treatment , at the completion of treatment, 3 months after completion of treatment  At start of the treatment , at the completion of treatment, 3 months after completion of treatment 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   26/11/2024 
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="1"
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  

Breast cancer is the most commonly diagnosed malignancy and the leading cause of death among women worldwide. Breast cancer alone is responsible for 30% (1) of newly diagnosed cancer cases in women and there is a probability that one in eight women will develop breast cancer in her lifetime, while 14% of cancer-related deaths are attributed to it. More than 100,000 patients are estimated to be diagnosed with breast cancer every year in India which depicts the disease burden. Breast cancer has been rising steadily over the last decade or so, and is now the most common cancer in women in India, way ahead of cervical cancer (which was the leading cancer previously). Breast cancer treatment is highly effective, especially when the disease is identified in early stage. Treatment of breast cancer often consists of a combination of surgery, radiation therapy and systemic therapy (hormonal therapy, chemotherapy and/or targeted biological therapy). This multi-modality treatment of breast cancer is also associated with certain acute and late adverse events affecting the quality of life of the patient.Hence, I am conducting present study to determine the Patient Reported Outcomes of acute toxicities and its overall affect on quality of life in this group of patients.

 
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