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CTRI Number  CTRI/2019/03/018235 [Registered on: 22/03/2019] Trial Registered Prospectively
Last Modified On: 25/08/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of presurgical exercises on tiredness, breathing capacity and quality of living of head and neck cancer patients undergoing surgery. 
Scientific Title of Study   Impact of prehabilitation on Cancer Related Fatigue (CRF), Functional Capacity and Quality of life (QOL) of Head and Neck Cancer patients undergoing neck dissection surgery. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Natasha Haresh Hassija 
Designation  Student 
Affiliation  CMC Vellore 
Address  Physiotherapy Unit PMR Department CMC Vellore

Vellore
TAMIL NADU
632002
India 
Phone  0416-2282663  
Fax  91-416-223-2035  
Email  hassijanatasha98@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Lenny Vasanthan T 
Designation  Lecturer 
Affiliation  CMC Vellore 
Address  Physiotherapy Unit PMR Department CMC Vellore

Vellore
TAMIL NADU
632002
India 
Phone  0416-2282663  
Fax  91-416-223-2035  
Email  lennyv@cmcvellore.ac.in  
 
Details of Contact Person
Public Query  
Name  Lenny Vasanthan T 
Designation  Lecturer 
Affiliation  CMC Vellore 
Address  Physiotherapy Unit PMR Department CMC Vellore

Vellore
TAMIL NADU
632002
India 
Phone  0416-2282663  
Fax  91-416-223-2035  
Email  lennyv@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
Fluid Research Grant Christian Medical College Vellore 632002 Tamil Nadu 
 
Primary Sponsor  
Name  Fluid Research Grant CMC Vellore 
Address  Carman Block CMC Campus Bagayam Vellore  
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 
Lenny Vasanthan T  Christian Medical College Vellore  Physical Medicine and Rehabilitation OPD and Surgery OPD CMC Vellore
Vellore
TAMIL NADU 		 0416-2282663
91-416-223-2035
lennyv@cmcvellore.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Prehabilitation  Home based exercise program for 3 weeks of which patients have to finish a minimum of 10 sessions to continue to be part of the study Patients will be followed up over the phone every week Exercise intervention includes Progressive Resistance Exercise training targeting certain groups of muscles in the upper extremity and a few groups in the lower extremity, core; resistance will be provided using water bottles,3mm surgical tubes and their own body weight,stretching for upper extremity typically focusing on the muscle groups around/close to the shoulder joint Aerobic exercise will also be prescribed (Walking prescription inclusive of warm up and cool down phase) Patients will be expected to continue the same set of exercises for a minimum of 10 sessions even after their surgery once they get clearance from the surgeon  
Comparator Agent  Routine Treatment  Range of motion exercises for shoulder Range of motion exercises for neck Range of motion exercises for mouth Postural re-education Patient education regarding impairments or complications following surgery Scar tissue mobilization  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All patients undergoing Selective Neck Dissection -1,2,3; Modified Radical Neck Dissection 1,2,3,4,5; Pectoralis Major Myocutaneous Flap

European Cooperative Oncology Group (ECOG) : 0-2
Negative response to all questions from Physical Activity Readiness Questionnaire (PAR-Q)

Platelet count more than 50,000 Haemoglobin more than 10.0 g/dl Absolute neutrophil count more than 0.5× 10⁹ WBC more than 5000/mm³ Hematocrit more than 25%  
 
ExclusionCriteria 
Details  Patients who are unable to comprehend the instructions given to them

Patients with pre-existing physical disability involving shoulder/neck

Primary treatment as chemotherapy/radiotherapy

Distant Metastases  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Functional Assessment Of Chronic Illness Therapy Head and Neck Cancer FACT HN Version4 to measure Quality of life
FACIT Fatigue scale Version 4 to evaluate Cancer related fatigue
Goniometer to measure Range of motion of shoulder
6 Minute Walk Test to record the Functional Capacity  		 FACT HN and FACIT Fatigue will be used along with 6 Minute Walk test in the assessments that will be done 3 weeks prior to surgery,once before surgery and 3 weeks after surgery
Goniometer assessment will be done 3 weeks after surgery
 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of stay in the hospital
Shoulder Pain And Disability Index SPADI Patient reported functional limitation
Neck Disability Index NDI Patient reported functional limitation 		 Shoulder Pain and Disability Index and Neck Disability Index will be used 3 weeks after surgery in the last assessment
Duration of hospital stay will be recorded during discharge following surgery 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   28/03/2019 
Date of Study Completion (India) 06/06/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  		 The main objective of this study is to evaluate the impact of prehabilitation on Head and Neck Cancer patients undergoing neck dissection surgery. All patients undergoing Selective Neck Dissection lymph node levels 1,2,3; Modified Radical Neck Dissection lymph node levels 1,2,3,4,5; Pectoralis Major Myocutaneous Flap will be included in the study. Patients will be recruited 3-4 weeks prior to their surgery and divided into two groups based on the computer generated randomized number. Based on the group they are in they will either be given the routine treatment which would include range of motion exercises for the neck, shoulder and mouth, postural re-education and scar mobilization techniques. Whereas the participants undergoing prehabilitation will have to undergo a 3-4 week home based program of which they have to complete a minimum of 10 sessions to continue to be part of the study. The prehabilitation intervention would include Progressive Resistance Exercise training, Stretching exercises and Aerobic exercise (Walking) ; participants would be expected to continue the same set of exercises even after their surgery once they get clearance from the surgeon. Before the commencement of any of the two exercise interventions the patients will be evaluated using the FACT H&N - Quality of life, FACIT Fatigue- Cancer related fatigue, 6 Minute Walk Test- Sub maximal Exercise Testing used to record functional capacity of the patient, the resting heart rate of the patient will be recorded and the Physical Activity Readiness Questionnaire (PARQ) will be used to check for any comorbidities. A second assessment using the same tools mentioned above will be carried out 1 day prior to their surgery. The 3rd assessment will be carried out 2-3 weeks following surgery which will include the same tools mentioned above however two new questionnaires for the evaluation of patient related outcomes for neck and shoulder disability (Neck Disability Index, Shoulder Pain And Disability Index) will be added during this phase of the assessment. Also, their duration of stay at the hospital will be recorded.    
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