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CTRI Number  CTRI/2025/12/098842 [Registered on: 10/12/2025] Trial Registered Prospectively
Last Modified On: 09/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Prehabilitation in Breast cancer 
Scientific Title of Study   Effectiveness of prehabilitation and Lymphedema education on clinical and Functional outcomes among Non-metastatic Breast cancer patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kavitha V 
Designation  Post Graduate student (MPT ONCOLOGY) 
Affiliation   
Address  Department of Oncology Physiotherapy, Sri Ramachandra Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research. No.1, Sri Ramachandra Nagar, Porur -600116

Chennai
TAMIL NADU
600116
India 
Phone  7358328165  
Fax    
Email  vkavithasai1998@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  K. Ramalakshmi 
Designation  Lecturer 
Affiliation  Sri Ramachandra Faculty of Physiotherapy, SRIHER 
Address  Department of Oncology Physiotherapy, Sri Ramachandra Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research. No.1, Sri Ramachandra Nagar, Porur -600116

Chennai
TAMIL NADU
600116
India 
Phone  7708680087  
Fax    
Email  ramalakshmi22@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  Kavitha V 
Designation  Post Graduate student (MPT ONCOLOGY) 
Affiliation  Sri Ramachandra Faculty of Physiotherapy, SRIHER 
Address  Department of Oncology Physiotherapy, Sri Ramachandra Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research. No.1, Sri Ramachandra Nagar, Porur -600116

Chennai
TAMIL NADU
600116
India 
Phone  7358328165  
Fax    
Email  vkavithasai1998@gmail.com  
 
Source of Monetary or Material Support  
Sri Ramachandra Hospital, No.1, Sri Ramachandra Nagar, Porur, Chennai, Tamil Nadu,600116 India 
 
Primary Sponsor  
Name  Kavitha V 
Address  Sri Ramachandra Faculty of Physiotherapy, SRIHER. No.1, Sri ramachandra nagar, Porur 600116 
Type of Sponsor  Other [] 
 
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 Kavitha V   Sri Ramachandra Hospital  2nd floor Oncology Out Patient Department and 5th floor Oncology In Patient Department. No.1,Sri Ramachandra Nagar, Porur, Chennai.
Chennai
TAMIL NADU 
7358328165

vkavithasai1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Prehabilitation group  Prehabilitation group will receive prehabilitation 1 – 2 weeks prior to surgery by direct 1:1 education for about 30-45 minutes and participants are instructed to follow the exercises at home and are monitored through tele-communication and standard post-operative physiotherapy care and lymphedema education will be given following surgery. Measures of intervention will be assessed at baseline, POD 1, Post drain removal, Post 1 month and 2 months of surgery. 
Comparator Agent  Standard Physiotherapy Group  Standard Physiotherapy Group will receive standard physiotherapy care and lymphedema education following surgery. Measures of intervention will be assessed at baseline, POD 1, Post drain removal, Post 1 month and 2 months of surgery. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Subjects aged between 25 and 60 years who comprehend to commands
2) Subjects who planned for Modified radical mastectomy, Simple mastectomy and Breast conserving surgery with Axillary lymphnode dissection.
 
 
ExclusionCriteria 
Details  1) Subjects with Metastatic breast cancer
2) Subjects who planned for Lumpectomy, Wide local excision, Flap reconstruction
3) Subjects undergoing Neoadjuvant Radiation therapy
4) Subjects with comorbidities of cardiopulmonary, neurological and musculoskeletal conditions.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Shoulder ROM, Grip Strength, SPADI questionnaire  Baseline, POD 1, Post drain removal, Post 1 month and Post 2 months of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Arm Circumference, Lymphedema Knowledge Survey  Baseline (1-2days prior to surgery), POD 1, Post drain removal, Post 1 month and Post 2 month 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/01/2026 
Date of Study Completion (India) 30/04/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Subjects who met inclusion criteria will be taken for this study from the Department of Medical Oncology and Department of Surgical Oncology in Sri Ramachandra Hospital. Subjects will be explained about the study and outcome of the study and written informed consent would be obtained. Based on the inclusion criteria subjects will be divided into 2 groups. Group A (Prehabilitation group) and Group B (Standard Physiotherapy group). Group A will receive prehabilitation and lymphedema education preoperatively 1 – 2 weeks prior to surgery by direct 1:1 education for about 30-45 minutes and participants are instructed to follow the exercises at home and are monitored through tele-communication and standard post-operative physiotherapy care will be given following surgery. Group B will receive standard physiotherapy care and lymphedema education. Both groups will be assessed shoulder ROM using goniometer, grip strength using handheld dynamometer, shoulder functional outcome using SPADI questionnaire, and arm circumference using inch tape during preoperatively (Experimental group: 1 – 2 weeks prior to surgery) (Control group: 1 – 2 days prior to surgery), post-operative day 1, post drain removal, and post 1 and 2 months of surgery. Awareness of lymphedema will be assessed by using Lymphedema Knowledge Survey before and after giving lymphedema education.

 
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