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CTRI Number  CTRI/2022/10/046869 [Registered on: 28/10/2022] Trial Registered Prospectively
Last Modified On: 27/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Dietary Intervention]  
Study Design  Randomized, Crossover Trial 
Public Title of Study   Effect of diet in Head and Neck Cancer patients  
Scientific Title of Study   Nutritional assessment and dietary intervention during and post chemo-radiotherapy for head and neck cancer patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pavana BP 
Designation  Student  
Affiliation  Welcomgroup graduate school of Hotel Administration. 
Address  Welcomgroup graduate school of Hotel Administration.Dept of Dietetics and Applied Nutrition Manipal
Welcomgroup graduate school of Hotel Administration.Dept of Dietetics and Applied Nutrition Manipal
Udupi
KARNATAKA
576104
India 
Phone  7829469300  
Fax    
Email  pavana.p@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Swathi Acharya  
Designation  Assistant Professor senior scale 
Affiliation  Welcomgroup graduate school of Hotel Administration. 
Address  Welcomgroup graduate school of Hotel Administration.Dept of Dietetics and Applied Nutrition Manipal
Welcomgroup graduate school of Hotel Administration.Dept of Dietetics and Applied Nutrition Manipal
Udupi
KARNATAKA
576104
India 
Phone  9535071393  
Fax    
Email  swathi.acharya@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Swathi Acharya  
Designation  Assistant Professor senior scale 
Affiliation  Welcomgroup graduate school of Hotel Administration. 
Address  Welcomgroup graduate school of Hotel Administration.Dept of Dietetics and Applied Nutrition Manipal
Welcomgroup graduate school of Hotel Administration.Dept of Dietetics and Applied Nutrition Manipal
Udupi
KARNATAKA
576104
India 
Phone  9535071393  
Fax    
Email  swathi.acharya@manipal.edu  
 
Source of Monetary or Material Support  
Shirdi Sai Baba Cancer Hospital and Research Centre Manipal -576104 Department of Radiotherapy and Oncology  
 
Primary Sponsor  
Name  Pavana B P 
Address  Welcomgroup graduate school of Hotel Administration. Dept of Dietetics and Applied Nutrition. 
Type of Sponsor  Other [SELF] 
 
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 Karthik S Udupa  Shirdi Sai Baba Cancer Hospital and Research Centre -Manipal   Medical oncology/day care SSBCH 14 Wards:SF4,SM5
Udupi
KARNATAKA 		 9845317153

udupa.karthik@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Commitee   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  Dietary intervention   Assessment and dietary modification is made according to the changes observed in the symptoms each week (0-6weeks)  
Intervention  Dietary intervention (Educational material)  Assessing Nutritional health status of head and neck cancer patients and providing them educational material 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients with squamous cell carcinoma of the oral cavity, oropharynx,hypopharynx or larynx undergoing or receiving chemo and radiotherapy who are
18-80 years old male and females 
 
ExclusionCriteria 
Details  Head and neck cancer patients with metabolic disorders such as High BP,Kidney disease and CVD,Pregnant ,Lactating, Lactose intolerant 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome measures will be assessment of overall nutritional status that is assessing their weight,MUAC,Biochemical parameters and dietary intake from day 0-6th week.  0,1,2,3,4,5,6th week 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome measure will be assessment of weight changes and their dietary pattern post dietary counselling.  0,1,2,3,4,5,6th week 
 
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   N/A 
Date of First Enrollment (India)   31/10/2022 
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="2"
Days="20" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [pavana.p@learner.manipal.edu].

  6. For how long will this data be available start date provided 31-10-2022 and end date provided 31-03-2023?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is an interventional study to assess the overall nutritional status of head and neck cancer patients and also to assess the impact of dietary modification on nutritional status of Head and Neck cancer patients during and post chemo-radiotherapy for which 35-40 patients are taken, this study will be conducted at Shirdi Saibaba Cancer Hospital and Research Centre, Manipal. The primary outcome measures will be assessment of overall nutritional status on day 0-6th week,Secondary outcome measure will be assessment of weight changes post dietary counselling. 
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