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CTRI Number  CTRI/2022/04/042236 [Registered on: 28/04/2022] Trial Registered Prospectively
Last Modified On: 02/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [OCCUPATIONAL THERAPY]  
Study Design  Other 
Public Title of Study   Occupational therapy and nutritional pre-operative intervention in bone sarcoma cases- A Feasibility study  
Scientific Title of Study   Multimodal prehabilitation in patients with bone sarcomas around knee joint- a feasibility study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manjusha Vagal 
Designation  Officer in Charge, Occupational Therapy Department 
Affiliation  Tata Memorial Hospital 
Address  Occupational Therapy Department, room no. 94, Tata Memorial Hospital, Dr. Ernest Borges Road, Parel Mumbai-12

Mumbai
MAHARASHTRA
400012
India 
Phone  9867552266  
Fax    
Email  vagalmanjusha@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Manjusha Vagal 
Designation  Officer in Charge, Occupational Therapy Department 
Affiliation  Tata Memorial Hospital 
Address  Occupational Therapy Department, room no. 94, Tata Memorial Hospital, Dr. Ernest Borges Road, Parel Mumbai-12

Mumbai
MAHARASHTRA
400012
India 
Phone  9867552266  
Fax    
Email  vagalmanjusha@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Mahesh alias Vibhav M Sanzgiri 
Designation  PG Student, Masters Of Occupational Therapy in Oncology 
Affiliation  Tata Memorial Hospital 
Address  Occupational Therapy Department, room no. 94, Tata Memorial Hospital, Dr. Ernest Borges Road, Parel Mumbai-12

Mumbai
MAHARASHTRA
400012
India 
Phone  9284193582  
Fax    
Email  maheshsanzgiry@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Dr. Ernest Borges Road, Parel Mumbai-12 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Dr. Ernest Borges Road, Parel Mumbai-12 
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 
Mahesh alias Vibhav M Sanzgiri  Tata Memorial Hospital  Occupational Therapy Department, room no. 94, Tata Memorial Hospital, Dr. Ernest Borges Road, Parel Mumbai-12
Mumbai
MAHARASHTRA 		 9284193582

maheshsanzgiry@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Tata Memorial Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C402||Malignant neoplasm of long bones of lower limb,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Multimodal prehabilitation including occupational therapy and nutritional intervention  Occupational therapy prehabilitation intervention will include- techniques to maintain positivie emotional health, fatigue management, functional tasks, adl and iadl management, mobility aid training, job and commutation management, pain management by relaxation techniques. Nutritional intevention will aim to maintain optimum nutritional levels of the patient. The occupational therapy intervention will be provided on one day before each chemotherapy cycle (4 in number) administration, on the first day of chemotherapy cycle administration and on the 21st day after last i.e. 4th chemotherapy cycle administration preoperatively hence in total 9 times before surgery and after surgery on completion of 1st, 2nd and 3rd month hence in total 3 times. Nutritional intervention will be provided on one day before each chemotherapy cycle and 21st day after last i.e. 4th chemotherapy cycle pre-operatively hence in total 5 times preoperatively; and post operatively on completion of 1st, 2nd and 3rd month hence in total 3 times.  
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with primary bone sarcomas of i.e., proximal tibia and distal end of femur
Patients planned for limb salvage surgery i.e., endoprosthetic reconstruction.
Before commencement of chemotherapy (3 weekly protocol, 4 cycles preoperatively and 4 cycles
post operatively).
Age group- 18-60 years old.
Gender- Males and Females.
Patients who are literate, able to read and understand Hindi or English language.
Patients willing to follow-up to occupational therapy dept. for defined prehabilitation period.
 
 
ExclusionCriteria 
Details  Patients pre- operated for primary bone sarcomas of proximal end of tibia including endoprosthetic
reconstruction.
Secondary bone sarcomas cases (bone metastasis).
Patients with disease progression
Patients receiving chemotherapy outside Tata Memorial Hospital
Patients with pathological fractures and distant metastasis and local recurrence.
Presence of prior mental, psychiatric, cognitive impairment that precludes self-care. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Since this is a feasibility study we shall be mentioning the scores (Performance components, DASS-21, MULTIDIMENSIONAL FATIGUE INVENTORY 20, SUBJECTIVE GLOBAL ASSESSMENT, CANADIAN OCCUPATIONAL PERFORMANCE MEASURE), proportion, ranges of patients who complete assessments.   Assessments will be conducted on following time points- baseline which will be done on one day before 1st chemotherapy administration, 1 day before 2nd, 3rd, 4th and 21st day after last i.e. 4th chemotherapy cycle. post operatively assessments will be done on completion of 1st, 2nd and 3rd month of surgery  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NOT APPLICABLE 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "22"
Final Enrollment numbers achieved (India)="22" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/04/2022 
Date of Study Completion (India) 12/06/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 The Indian Journal of Occupational Therapy 56(3):p 82-86, Jul–Sep 2024. | DOI: 10.4103/ijoth.ijoth_60_24 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   THIS IS A FEASIBILITY STUDY, WE WILL BE RECRUITING PATIENT’S WHO ARE CASE OF DITAL FEMUR OR PORXIMAL TIBIA BONE SARCOMAS, PLANNED FOR ENDOPROSTHETIC RECONSTRUCTION AND NEO ADJUVANT CHEMOTHERAPY. THEY WILL BE EVALUTAED FOR POST-OPERATIVE STATUS TOO. 
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