| CTRI Number |
CTRI/2026/01/100590 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
06/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Helping Breast Cancer Survivors with Arm Swelling: Testing a Physiotherapy Program for Reducing Lymphedema After Lymph Node Surgery. |
|
Scientific Title of Study
|
AN INTEGRATED PHYSIOTHERAPEUTIC APPROACH IN MANAGING POST LUMPECTOMY LYMPHEDEMA:A RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHIKHA GUPTA |
| Designation |
PHD SCHOLAR |
| Affiliation |
SGT UNIVERSITY |
| Address |
DEPARTMENT OF PHYSIOTHERAPY,SGT MEDICAL COLLEGE, HOSPITAL AND RESEARCH INSTITUTE GURGAON HARYANA INDIA
122001
DEPARTMENT OF PHYSIOTHERAPY,SGT MEDICAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE GURGAON HARYANA INDIA
122001
Gurgaon
HARYANA
122001
India |
| Phone |
9560363577 |
| Fax |
|
| Email |
Physioshikha23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRPRIYANKA RISHI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SGT UNIVERSITY |
| Address |
DEPARTMENT OF PHYSIOTHERAPY, SGT UNIVERSITY,GURGAON
DEPARTMENT OF PHYSIOTHERAPY, SGT UNIVERSITY, GURGAON
Gurgaon
HARYANA
122001
India |
| Phone |
8588878467 |
| Fax |
|
| Email |
Prnk.rishi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PRIYANKA RISHI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SGT UNIVERSITY |
| Address |
DEPARTMENT OF PHYSIOTHERAPY, SGT UNIVERSITY, GURGAON
DEPARTMENT OF PHYSIOTHRERAPY,SGT UNIVERSITY,GURGAON
Gurgaon
HARYANA
122001
India |
| Phone |
8588878467 |
| Fax |
|
| Email |
Prnk.rishi@gmail.com |
|
|
Source of Monetary or Material Support
|
| SGT UNIVERSITY GURGAON
HARYANA, INDIA
122001 |
|
|
Primary Sponsor
|
| Name |
SHIKHA GUPTA |
| Address |
SGT UNIVERSITY |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| PRIYANKA RISHI |
SGT MEDICAL HOSPITAL |
DEPARTMENT OF PHYSIOTHERRAPY,SGT MEDICAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE
GURGAON HARYANA INDIA
122001
Gurgaon
HARYANA |
08588878467
Prnk.rishi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| FPHY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
COMPLETE DECONGESTIVE THERAPY(CDT)+LYMPHASTIM INTERMITTENT PNEUMATIC COMPRESSION(IPC)+STM( SOFT TISSUE MOBILISATION)+EXERCISES+PMR(PROGRESSIVE MUSCLE RELAXATION) |
INTERVENTION IS GIVEN AT HOSPITAL FOR 3 TIMES A WEEK FOR 6 WEEKS |
| Comparator Agent |
MLD(MANUAL LYMPHATIC DRAINAGE)+COMPRESSION BANDAGING+EXERCISES |
TREATMENT GIVEN AT CLINIC FOR 3 TIMES A WEEK FOR 6 WEEKS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
BREAST CANCER FEMALE AGED ABOVE 18 YEARS WHO UNDERGONE BREAST CANCER SUREGERY AND HAD LYMPHEDEMA STAGE 2 AND 3, HAVING SYMPTOM OF PAIN, HRAVINESS AND FIBROSIS, ABLE TO FOLLOW THE COMMANDS AND AGREE TO WEAR COMPRESSION GARMENT OR BANDAGING FOR 12 HOURS PER DAY. |
|
| ExclusionCriteria |
| Details |
PATIENTS WHO UNDERGOING OR SCHEDULED A CHEMOTHERAPY OR RADIATION THERAPY, PRESENT WITH LIMB INFECTION,DVT, OR HAS ACTIVE METASTATIC DISEASE, HAS NEUROLOGICAL OR COGNITIVE DEFICITS, HAS ANY CONTRADICTIONS TO USE COMPRESSION ON LIMB |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| LIMB VOLUME PERCENTAGE CHANGE VIA CIRCUMFERENCE METHOD,ARTERIAL CIRCULATION BY ANKLE BRACHIAL PRESSURE INDEX,RANGE OF MOTION OF SHOULDER AND ELBOW JOINT, PAIN BY VAS, FATIQUE |
at baseline and at the end of 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ANXIETY AND DEPRESSION, BODY IMAGE, QUALITY OF LIFE, |
BASELINE , WEEK6 |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
20/01/2026 |
| 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 Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 31-01-2026 and end date provided 31-03-2026?
Response (Others) -
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
BREAST CANCER RELATED LYMPHEDEMA IS A COMMON CHRONIC COMPLICATION AMONG BREAST CANCER SURVIVORS OFTEN RESULTING IN PERSISTENT SWELLING TISSUE FIBROSIS PAIN REDUCED MOBILITY AND POOR QUALITY OF LIFE WHILE STANDARD COMPLETE DECONGESTIVE THERAPY COMPRISING MANUAL LYMPHATIC DRAINAGE COMPRESSION BANDAGING EXERCISES AND SKIN CARE REMAINS THE MAINSTAY OF TREATMENT MANY SURVIVORS CONTINUE TO SUFFER FUNCTIONAL TISSUE AND PSYCHOLOGICAL SEQUELE THIS RANDOMIZED CONTEOLLED TRIAL AIMS TO EVALUATE WHETHER AN INTEGRATED PHYSIOTHERAPEUTIC APPROACH COMBINING CDT WITH INTERMITTENT PNEUMATIC COMPRESSION SOFT TISSUE MOBILIZATION THERAPEUTIC EXERCISES PLUS PROGRESSIVE MUSCLE RELAXATION PRODUCES SUPERIOR OUTCOMES COMPARED WITH STANDARD CDT ALONE OVER SIX WEEKS IN POST LUMPECTOMY WOMEN WITH STAGE 2 AND 3 BCRL OUTCOMES INCLUDE LIMB VOLUME REDUCTION RANGE OF MOTION PAIN STRENGTH FATIQUE ARTERIAL CIRCULATION AND PSYCHOLOGICAL MEASURES LIKE ANXIETY BODY IMAGE QUALITY OF LIFE ASSESSED AT BASELINE AND AT WEEK 6 |