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CTRI Number  CTRI/2023/02/049509 [Registered on: 07/02/2023] Trial Registered Prospectively
Last Modified On: 26/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Changes in shoulder movement after patients undergo surgeries for breast cancer 
Scientific Title of Study   Shoulder dysfunction in patients undergoing surgical procedures for breast cancer 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Menaita M Lala 
Designation  Junior Resident 
Affiliation  Kasturba Medical College and Hospital, Manipal 
Address  Department of General Surgery, 3rd floor, Smt. Sharadha Madhav Pai OPD building, Kasturba Hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8879116555  
Fax    
Email  menaita.lala@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Stanley Mathew  
Designation  Professor and Head of Unit 
Affiliation  Kasturba Medical College and Hospital, Manipal 
Address  Department of General Surgery, 3rd floor, Smt. Sharadha Madhav Pai OPD building, Kasturba Hospital, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9844409900  
Fax    
Email  stanley.mathew@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Ms Kavitha Vishal 
Designation  Assistant Professor Selection Grade  
Affiliation  Manipal College of Health Professions, MAHE 
Address  Department of Physiotherapy, Manipal College of Health Professions, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9986526077  
Fax    
Email  kavitha.vishal@manipal.edu  
 
Source of Monetary or Material Support  
Department of General Surgery, Kasturba Medical College, Manipal 
 
Primary Sponsor  
Name  Dean, Kasturba Medical College, Manipal  
Address  First Floor, Administrative Block, Kasturba Medical College, Manipal, Udupi, Karnataka 576104 
Type of Sponsor  Private medical college 
 
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 Stanley Mathew  Kasturba Hospital, Manipal  Department of General Surgery, 3rd floor, Smt. Sharadha Madhav Pai OPD building, Kasturba Hospital, Manipal 576104
Udupi
KARNATAKA 		 9844409900

stanley.mathew@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C508||Malignant neoplasm of overlappingsites of breast, (2) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, (3) ICD-10 Condition: M625||Muscle wasting and atrophy, not elsewhere classified, (4) ICD-10 Condition: M999||Biomechanical lesion, unspecified, (5) ICD-10 Condition: M759||Shoulder lesion, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Active shoulder exercises   Active exercises for increasing range of movement of shoulder. Active exercises for increasing power of muscles of shoulder Duration : 3 months 
Comparator Agent  Normal contralateral unaffected shoulder function  Normal contralateral unaffected shoulder range of movement and power will be assessed for comparison Duration : 3 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Female 
Details  Biopsy proven breast cancer patients undergoing axillary dissection as part of breast conservation surgery or modified radical mastectomy  
 
ExclusionCriteria 
Details  1) Recurrent breast cancer
2) Bilateral breast cancer
3) Prior history of radiation to the breast or axilla
4) Patients with pre existing shoulder pathology in either arm 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Shoulder dysfunction measured 3 months post operatively using the DASH questionnaire and range of motion compared between operated and non operated sides 3 months post operatively  3 months  
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="33"
Sample Size from India="33" 
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)   10/02/2023 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response (Others) -  Any regulatory agency or editor / reviewer of a scientific publication

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  Data will be provided based on a written request

  6. For how long will this data be available start date provided 01-03-2025 and end date provided 01-03-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   All breast cancer patients who undergo breast surgery along with axillary dissection and fulfil the inclusion and exclusion criteria will be approached by the PI to be a part of the study. After obtaining consent, the participant will be requested to fill up the DASH assessment chart preoperatively. The patient will then undergo the standard of care operative procedure. Post operatively the patient will be made to follow a standardised exercise regimen including shoulder stretching and strengthening as well as scapular exercises from post operatively. The patient will be requested to fill up the DASH assessment chart 3 months postoperatively. The range of motion will be compared between the operated and non operated sides to determine the dysfunction.  
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