| 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
|
|
|
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
|
|
|
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
|
|
|
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. |