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CTRI Number  CTRI/2025/09/094990 [Registered on: 17/09/2025] Trial Registered Prospectively
Last Modified On: 10/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Predicting chemotherapy tolerance in older adults: Link with health and diet 
Scientific Title of Study   Impact of nutritional and health indicators on chemotoxicity in elderly patients planned for chemotherapy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  AISHWARYA M S 
Designation  STUDENT  
Affiliation  Welcomgroup Graduate School of Hotel Administration 
Address  Chanakya 2,first floor, Department of Dietetics And Applied Nutrition, Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka.

Udupi
KARNATAKA
576104
India 
Phone  9902075038  
Fax    
Email  aishwarya.wgshampl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Namratha Pai K  
Designation  Assistant Professor  
Affiliation  Welcomgroup Graduate School of Hotel Administration 
Address  Department of Dietetics and Applied Nutrition, Faculty room no.1, Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka.

Udupi
KARNATAKA
576104
India 
Phone  9738364472  
Fax    
Email  namratha.paik@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Namratha Pai K  
Designation  Assistant Professor  
Affiliation  Welcomgroup Graduate School of Hotel Administration 
Address  Department of Dietetics and Applied Nutrition, Faculty room no.1, Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka.

Udupi
KARNATAKA
576104
India 
Phone  9738364472  
Fax    
Email  namratha.paik@manipal.edu  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Aishwarya M S 
Address  Department of Dietetics and Applied Nutrition, Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education, Manipal, Karnataka - 576104 
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 Sharada M  Shirdi Sai Baba Cancer Hospital and Research Centre   Shirdi Sai Block, Manipal Comprehensive Cancer Care Centre, Department of Medical Oncology,4th floor, KMC Manipal, Manipal
Udupi
KARNATAKA 
9787689031

sharada.m@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Geriatric patients with cancer planned for undergoing chemotherapy.  
 
ExclusionCriteria 
Details  pediatric, adolescent, adults below 60 years of age and patients undergoing palliative care and radiotherapy  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assess the impact of nutritional indicators such as Mini nutritional assessment, Food frequency questionnaire, 24 hour recall, serum protein levels and anthropometric data and health indicators such Short form survey-36 in reducing chemotoxicity in elderly patients undergoing chemotherapy for cancer  Assess the impact of nutritional indicators such as Mini nutritional assessment, Food frequency questionnaire, 24 hour recall, serum protein levels and anthropometric data and health indicators such Short form survey-36 in reducing chemotoxicity in elderly patients undergoing chemotherapy for cancer 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   22/09/2025 
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="3"
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 how nutritional and health indicators, such as weight, muscle status, and malnutrition risk, can predict the likelihood and severity of chemotoxicity in elderly cancer patients. The expected outcome is to establish a link between these indicators and a patient’s readiness for chemotherapy, allowing for the identification of high-risk individuals. The findings could pave the way for future research into developing and testing targeted nutritional interventions before chemotherapy begins. Such research could explore the efficacy of specific dietary plans or nutritional supplements in improving treatment tolerance and quality of life for geriatric oncology patients.

This study will investigate whether a patient’s nutritional and health status can predict their tolerance to chemotherapy by examining geriatric cancer patients at Shirdi Sai Baba Cancer Hospital in Manipal. The selection criteria will focus on elderly individuals (60+) who are scheduled for chemotherapy and are able to participate fully in the study. The methodology involves a two-phase approach: a baseline assessment before treatment and a follow-up after 3 chemotherapy cycles. The initial assessment will collect extensive data, including anthropometric measurements (weight, height, MUAC, calf circumference), muscle strength via handgrip dynamometer, skinfold thickness via a skinfold caliper and validated nutritional assessments (MNA) and quality of life surveys (SF-36). Additionally, biochemical parameters will be taken to measure key serum proteins like albumin, globulin and total serum protein from the hospital report. The dietary assessment will be carried using 24 hour recall and a food frequency questionnaire. The follow-up will repeat these measurements and document the severity of any chemotoxicity using established clinical criteria, such as the CTCAE, to correlate the patient’s initial health with their treatment outcome. This comprehensive approach aims to create a predictive model for chemotoxicity risk, enabling healthcare providers to identify and intervene with at-risk patients before they begin treatment.

 
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