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CTRI Number  CTRI/2024/02/062366 [Registered on: 07/02/2024] Trial Registered Prospectively
Last Modified On: 28/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Pre Post Comparison Study]  
Study Design  Other 
Public Title of Study   Effect of "MORE" exercise program on head and neck cancer patients undergoing anti-cancer treatments in a hospital setting. 
Scientific Title of Study   Effectiveness of a Multimodal Oncology Rehabilitation Exercise Program (MORE) on the Cognitive, Physical and Psychosocial Domains of Head and Neck Cancer Survivors Undergoing Chemoradiotherapy (CRT) in a tertiary care hospital in Dakshina Kannada district.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Hritika Pai 
Designation  PhD Scholar  
Affiliation  Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Manipal, India. 
Address  Department of Physiotherapy, KMC Centre for Basic Sciences, Bejai, Mangaluru, Karnataka.

Dakshina Kannada
KARNATAKA
575004
India 
Phone  7506008912  
Fax    
Email  hritika.mchpmlr2022@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Vijaya Kumar K  
Designation  Additional Professor 
Affiliation  Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Manipal, India. 
Address  Department of Physiotherapy, KMC Centre for Basic Sciences, Bejai, Mangaluru, Karnataka.

Dakshina Kannada
KARNATAKA
575004
India 
Phone  9980189597  
Fax    
Email  vijay.kk@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Vijaya Kumar K  
Designation  Additional Professor 
Affiliation  Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Manipal, India. 
Address  Department of Physiotherapy, KMC Centre for Basic Sciences, Bejai, Mangaluru, Karnataka.

Dakshina Kannada
KARNATAKA
575004
India 
Phone  9980189597  
Fax    
Email  vijay.kk@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College Hospital, Attavar, Mangalore, Karnataka, 575002. 
 
Primary Sponsor  
Name  Department of Physiotherapy  
Address  Department of Physiotherapy, Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Manipal. 
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 
Hritika Pai   Kasturba Medical College Mangalore, Attavar  Department of Physiotherapy, KMC Center for Basic Sciences, Bejai, Mangalore.
Dakshina Kannada
KARNATAKA 		 7506008912

hritika.mchpmlr2022@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commjttee · Kasturba Medical College, Mangalore  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  The MORE program   Interventions included in the MORE program will be conducted 3 days/week for 8 weeks (time points T1, T2 and T3) for a period 2 years. The program will constitute 60-minute sessions, with interventions specific to each domain lasting for 15 minutes. Post the T3 time point, the HNC survivors enrolled in the program will be provided with an individualised home-based exercise templates to be continued post discharge, until the T4 time point wherein re-assessments will be conducted. Cognitive Domain - Cognitive motor exercises Physical Domain - Exercises pertaining to the upper and lower extremity and exercises for trismus (difficulty in mouth opeining). Psychosocial Domain - Relaxation strategies and counselling  
Comparator Agent  The MORE program   The MORE program is a single arm - before and after comparison study. Hence there is NO comparator agent involved.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  a)Histologically proven primary diagnosis of HNC - TNM stages III, IVA and IVB
b)Age 18 years to 100 years
c)Patients planned for definitive chemoradiotherapy (CRT)
d)Clearance from the attending physician (Radiation Oncologist)
e)Eastern Cooperative Oncology Group (ECOG) score 0-2
 
 
ExclusionCriteria 
Details  a)Patients with reduced alertness
b)Patients with non-ambulatory status
c)Any distant metastases
d)Any medical complication limiting participation in exercise
e)Significant cardiac, respiratory, neurologic or orthopaedic conditions that could influence the successful completion of the exercise regime
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
(Patient Health Questionnaire) PHQ – 4 scale   Baseline
Week 4
Week 8
3rd Month (Follow-up)  
 
Secondary Outcome  
Outcome  TimePoints 
1. Functional Assessment of Cancer therapy – Cognitive Function (FACT-Cog) version 3 scale
2. The 6 – Minute Walk Test (6MWT) distance
3. The JAMAR hand held dynamometer
4. The 5 times sit – to – stand test
5. The NCCN 10 point fatigue scale
6. The Pittsburgh Sleep Quality Index
 		 Baseline
Week 4
Week 8
3rd Month (Follow-up)  
 
Target Sample Size   Total Sample Size="106"
Sample Size from India="106" 
Final Enrollment numbers achieved (Total)= "118"
Final Enrollment numbers achieved (India)="118" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/03/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 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   The study aims to determine the effectiveness of integrating an 8-week Multimodal Oncology Rehabilitation Exercise (MORE) program on the cognitive, physical and psychosocial outcomes of HNC survivors undergoing chemoradiotherapy (CRT) in tertiary care hospital in Dakshina Kannasa district. In addition, this study also aims to evaluate the effectiveness of an integrated 8 week MORE program domain as well as the overall QOL of HNC survivors. Furthermore, to evaluate the efficacy of the MORE program on the physical parameters i.e., functional capacity and muscle strength among the survivors.  
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