| 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
|
|
|
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
|
|
|
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. |