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CTRI Number  CTRI/2023/03/050509 [Registered on: 09/03/2023] Trial Registered Prospectively
Last Modified On: 09/03/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Music therapy]  
Study Design  Single Arm Study 
Public Title of Study   study to test the effect of music on quality of life of cancer patients undergoing chemotherapy 
Scientific Title of Study   A prospective pilot study to assess the effect of MUSIc therapy on quality of life of Cancer patients undergoing Chemotherapy in Oncology day care - (MUSICC) 
Trial Acronym  MUSICC 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sujith Kumar Mullapally 
Designation  Consultant Medical Oncologist 
Affiliation  Apollo Proton Cancer Centre 
Address  Chemotherapy Day Care, 3rd Floor, Apollo Proton Cancer Centre, 4/661, Dr Vikram Sarabai Instronic Estate 7th St, Dr. Vasi Estate, Phase II, Tharamani, Chennai
4/661, Dr Vikram Sarabai Instronic Estate 7th St, Dr. Vasi Estate, Phase II, Tharamani, Chennai
Chennai
TAMIL NADU
600041
India 
Phone  8547889291  
Fax    
Email  drsujith_m@apollohospitals.com  
 
Details of Contact Person
Scientific Query
 
Name  Sujith Kumar Mullapally 
Designation  Consultant Medical Oncologist 
Affiliation  Apollo Proton Cancer Centre 
Address  Chemotherapy Day Care, 3rd Floor, Apollo Proton Cancer Centre, 4/661, Dr Vikram Sarabai Instronic Estate 7th St, Dr. Vasi Estate, Phase II, Tharamani, Chennai
4/661, Dr Vikram Sarabai Instronic Estate 7th St, Dr. Vasi Estate, Phase II, Tharamani, Chennai
Chennai
TAMIL NADU
600041
India 
Phone  8547889291  
Fax    
Email  drsujith_m@apollohospitals.com  
 
Details of Contact Person
Public Query
 
Name  Sujith Kumar Mullapally 
Designation  Consultant Medical Oncologist 
Affiliation  Apollo Proton Cancer Centre 
Address  Chemotherapy Day Care, 3rd Floor, Apollo Proton Cancer Centre, 4/661, Dr Vikram Sarabai Instronic Estate 7th St, Dr. Vasi Estate, Phase II, Tharamani, Chennai
4/661, Dr Vikram Sarabai Instronic Estate 7th St, Dr. Vasi Estate, Phase II, Tharamani, Chennai
Chennai
TAMIL NADU
600041
India 
Phone  8547889291  
Fax    
Email  drsujith_m@apollohospitals.com  
 
Source of Monetary or Material Support  
Apollo Proton Cancer Centre, 4/661, Dr Vikram Sarabai Instronic Estate 7th St, Dr. Vasi Estate, Phase II, Tharamani, Chennai 
 
Primary Sponsor  
Name  Apollo Proton Cancer Centre 
Address  4/661, Dr Vikram Sarabai Instronic Estate 7th St, Dr. Vasi Estate, Phase II, Tharamani, Chennai 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
DIGINXTHLT SOLUTIONS SERVICES Pvt Ltd   No 422, 9th Main 1st Block, Kalyan Nagar, HRBR Layout, Bengaluru, Bangalore, Karnataka, India, 560043 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sujith Kumar Mullapally  Apollo Proton Cancer Centre  Chemotherapy Day Care, 3rd Floor, Apollo Proton Cancer Centre, 4/661, Dr Vikram Sarabai Instronic Estate 7th St, Dr. Vasi Estate, Phase II, Tharamani, Chennai
Chennai
TAMIL NADU 
8547889291

drsujith_m@apollohospitals.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - Bio Medical Research, Apollo Hospitals  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Music Therapy  Sounds rendered by “echo Care” AI based application developed by DigiNxtHlt Solutions and service P Ltd. The patients will listen to the music/sounds for 30 minutes during each chemotherapy session for 6 weeks 
Comparator Agent  N/A  N/A 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1. Patients with a confirmed diagnosis of cancer undergoing chemotherapy in the daycare facility
2. Patients aged >18 years
3. Patients who are about to start chemotherapy (both curative, palliative intent)
4. Physical condition ( minimum performance status of ECOG 3)
5. Patients with acceptable English comprehension

 
 
ExclusionCriteria 
Details  1. Patients who have already started chemotherapy
2. Lack of English comprehension as the tools of assessment are validated only in English in the digital platform
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Quality of life  0,3,6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
predefined health parameters like blood pressure  0, 3, 6 weeks 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   N/A 
Date of First Enrollment (India)   15/03/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Background and Rationale

People who have cancer may find the physical, emotional, and social effects of the disease to be stressfulDistress has become increasingly recognized as a factor that can reduce the quality of life of cancer patients.  Those who are unable to manage their stress may have a poorer quality of life after cancer treatment. In contrast, people who are able to use effective coping strategies to deal with stress have been shown to have lower levels of depression, anxiety, and symptoms related to cancer and its treatment.

 

Music therapy has been extensively used for various conditions related to the mind. However, music preference is very subjective and often rendering music by a performer can be cumbersome, the publicly available music is not designed to cater to the specific needs of the listener or do not have the required calming and therapeutic benefits. Music by ‘echo care’ are engineered at frequencies to render calming effect, improve sleep, elevate mood and reduce stress & anxiety as the case may be. This study is to observe the health benefits of music on the quality of life of the patients.

General aim

The aim of this study is to observe the effects of music therapy  and standard care  in patients with  measured using the EORTC QLQ C30 scale, FACT G7 & HADS before and after the application of music/sound therapy

Primary objective (endpoint)

 

To evaluate the impact of  Music therapy “  on the Quality of life during chemotherapy. . 

Secondary objectives (endpoints)            

To evaluate the benefits of non-pharmacological, non-invasive, based intervention using echocare  music therapy on the anxiety levels and physiological parameters like blood pressure when patients undergo music therapy at start of chemotherapy, during chemotherapy and at the completion of chemotherapy      

Design  

The study will be conducted at Apollo Proton Cancer Centre at Chennai, India location. A sample size of 50 cancer patients undergoing chemotherapy in the day-care will be part of the study. The age range for this study will be 18 and above. The duration of this study will be for 2 to 3 months. 

Patient qualification for the study will be done by the attending consultant. The patients will be identified based on their fitment for music therapy which includes physical condition, patient & attendant’s consent and their English language comprehension.

 

Population

All Genders above the age of 18 undergoing cancer treatment at Apollo proton Chemotherapy Day Care centre

Statistical considerations

 

To be filled by Dr Pankaj 

 
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