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CTRI Number  CTRI/2024/10/075163 [Registered on: 11/10/2024] Trial Registered Prospectively
Last Modified On: 21/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effects of Integrative Yoga on Quality of Life, Cognitive Function, and Symptom Management in Head and Neck Cancer Patients During Chemo Radiation: A Randomized Controlled Trial. 
Scientific Title of Study   The Impact of integrative yoga intervention on quality of life, cognitive function, symptom management and fear of recurrence in head and neck cancer patients during chemo radiation : A Randomized Control 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  Akshaya K 
Designation  PhD Scholar 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  45/20 , Narasier street Old washermenpet

Chennai
TAMIL NADU
600021
India 
Phone  9342385092  
Fax    
Email  akshayak@sriramachandra.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Akshaya K 
Designation  PhD Scholar 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  45/20 Narasier street Old washermenpet

Chennai
TAMIL NADU
600021
India 
Phone  9342385092  
Fax    
Email  akshayak@sriramachandra.edu.in  
 
Details of Contact Person
Public Query  
Name  Akshaya K 
Designation  PhD Scholar 
Affiliation  Sri Ramachandra Institute of Higher Education and Research 
Address  45/20 Narasier street Old washermenpet

Chennai
TAMIL NADU
600021
India 
Phone  9342385092  
Fax    
Email  akshayak@sriramachandra.edu.in  
 
Source of Monetary or Material Support  
Sri NVP Udayar fellowship grant offered by Sri Ramachandra University of Higher Education and Research. 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [NA] 
 
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 Vijayalakshmi  Sri Ramachandra Institute of Higher Education and Research  Department of Radiation Oncology, G block , 5th floor IP.
Chennai
TAMIL NADU 		 9840723539

vijayalakshmi.p@sriramachandra.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C760||Malignant neoplasm of head, face and neck,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Integrative Yoga   Dynamic breathing exercises, Asanas , Pranayama and yogic counselling 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Confirmed diagnosis of HNC
2. Scheduled to receive chemo radiation therapy
3. Medically stable
4. Able to provide informed consent and participate yoga sessions safely
5. Free from significant psychological or neurological disturbances that interfere with participation.
6. No recent physical amputation
7. Willing to adhere to the research process 
 
ExclusionCriteria 
Details  1. Metastatic disease.
2. Prior history of psychiatric disturbances or musculoskeletal conditions.
3. Active uncontrolled psychiatric illness
4. Inability to participate in physical activity safely ( i.e., Patient with tracheostomy and recent physical amputation).
5. HPV negative larynx cancer (considered radio sensitive and may require different treatment approach).
6. Stage 4b HNC 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Quality of life : FACT-Q and PROMIS measures will be used to asses physical , emotional , social and spiritual well being.
2. Blood and bio markers - Corisol level and BDNF expression 		 Pre intervention , Post intervention and 4 week follow up 
 
Secondary Outcome  
Outcome  TimePoints 
1.Cognitive function measures which evaluates memory , attention and processing speed.
2. Pain , sleep quality and fatigue would be evaluated.
3. Fear of recurrence of disease would be evaluated. 		 Pre intervention , Post intervention and 4 week follow up 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   Phase 3 
Date of First Enrollment (India)   01/11/2024 
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="0"
Months="8"
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 - NO
Brief Summary   This study aims to evaluate the efficacy of a structured yoga program in improving Qualiity of life , Cognitive function , symptom management and Fear of recurrence of the disease in Head and Nech cancer patients undergoing chemoradiation compared to standard care control group. We further aim to explore potential biological mechanisms underlying these effects by measuring cortisol level , BDNF ( Brain derived neurotropic factor ) expression and Neurocognitive functioning in HNC patients. 
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