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CTRI Number  CTRI/2018/09/015801 [Registered on: 24/09/2018] Trial Registered Prospectively
Last Modified On: 28/11/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Trial on the Effect of Indian Classical music on Head and Neck Cancer patients.  
Scientific Title of Study   A Randomized Controlled Trial On The Effect of Indian Classical Music For Chemotherapy and Radiotherapy Induced Anxiety, Pain and Mood Disturbance in Head and Neck Cancer - A Pilot Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  P U Prakash Saxena 
Designation  Professor and Head of the Department 
Affiliation  Kasturba Medical College, Mangalore 
Address  Department of Radiotherapy and Oncology, Kasturba Medical College and Hospital, Attavar, Mangalore, Manipal Academy of Higher Education, Karnataka.

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9008761002  
Fax    
Email  pu.saxena@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  P U Prakash Saxena 
Designation  Professor and Head of the Department 
Affiliation  Kasturba Medical College, Mangalore 
Address  Department of Radiotherapy and Oncology, Kasturba Medical College and Hospital, Attavar, Mangalore, Manipal Academy of Higher Education, Karnataka.

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9008761002  
Fax    
Email  pu.saxena@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  P U Prakash Saxena 
Designation  Professor and Head of the Department 
Affiliation  Kasturba Medical College, Mangalore 
Address  Department of Radiotherapy and Oncology, Kasturba Medical College and Hospital, Attavar, Mangalore, Manipal Academy of Higher Education, Karnataka.

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9008761002  
Fax    
Email  pu.saxena@manipal.edu  
 
Source of Monetary or Material Support  
Manipal Academy of Higher Education internal funding for research 
 
Primary Sponsor  
Name  Manipal Academy of Higher Education internal funding for research 
Address  Kasturba Medical College, Manipal Academy of Higher Education, Mangalore. 
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 P U Prakash Saxena  Department of Radiotherapy, Ground floor,Kasturba Medical College and Hospital Attavar.  Department of Radiotherapy
Dakshina Kannada
KARNATAKA 
9008761002

pu.saxena@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
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: C109||Malignant neoplasm of oropharynx,unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Indian classical music therapy  Cases will listen to Indian classical music using earphones for about half an hour for 5 days a week. Selection of specific “raga” would be according to the inherited knowledge prevailed in centuries in the Indian classical music. The music is relaxing and will be played in their choice of volume level and location (bedside or soundproof room inside the hospital). Analysis using questionnaire will be done at 0th 3rd and 5th week of their radio therapy. 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All patients who are diagnosed with Head and neck cancer - squamous cell carcinoma who are treated with chemotherapy an radiotherapy at Kasturba Medical College and Hospital. 
 
ExclusionCriteria 
Details  This study excludes patients who are less than 18 years of age, having a hearing deficit, not suitable for chemotherapy and radiotherapy and not willing to give consent. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction of the chemotherapy- radiotherapy induced anxiety, pain and mood disturbance after listening to the Indian classical music.  0th 3rd and 5th week of study. 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction of anxiety, pain and mood disturbance  0th,3rd and 5th week. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/10/2018 
Date of Study Completion (India) 26/08/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 26/08/2019 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
None yet. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

This is a randomized controlled trial among patients who are treated with radiation therapy for diagnosed head and neck cancer at tertiary oncology care centre KMCH, Attavar in Mangalore, South India. Selection of specific “raga” would be according to the inherited knowledge prevailed in centuries in the Indian classical music. This study includes all the patients who were diagnosed with Head and neck squamous cell carcinoma and treated under chemotherapy and radiotherapy at Kasturba Medical College and Hospital. The diagnosis of Head and neck cancer established by histopathologic  study. Demographic details, clinical staging, comorbidity status, treatment, recurrence, follow up data, would also be analyzed along with music therapy outcome. This study excludes those patients who were less than 16 years of age, having hearing deficit, not suitable for CT-R and not willing to consent. Our objectives are to study the effect of specifically selected “raga” in Indian classical music in patients undergoing CT-RT (chemo-RT) for head and neck cancer, analyze the therapeutic use of specific “raga” in Indian classical music in cancer patients and to study the music therapy (specific “raga” in Indian classical music) outcomes. This study would probe into the therapeutic use of Indian classical music among all the head and neck cancer patients taking radiotherapy from the centers of analysis so that the fraction of patients getting this music therapy can be analyzed along. We also look forward to see whether the outcomes had changed with the music therapy which is serious concern in regard to the survival. We will analyze the cases and controls at 0th, 3rd and the 5th/7th week of Radiation using pretested semi-structured questionnaires (Hamilton anxiety rating scale, Hospital anxiety and depression scale and visual analogue scale for pain). The data will be analyzed using SPSS version 17. Results will be expressed in proportions and standard derivations. Chi-square test and t test will be used to test statistical significance.  P value of <0.05 will be considered significant.

 
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