| CTRI Number |
CTRI/2025/11/097611 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
17/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Personalized diet chart ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Personalized Diet on Cancer-Related Fatigue in Breast Cancer Patients During Chemotherapy |
|
Scientific Title of Study
|
Impact of Personalized Nutrition on Cancer-Related Fatigue in Breast Cancer Patients Undergoing Chemotherapy: An Interventional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jonathan Eldad E |
| Designation |
Senior resident (DM resident) |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Medical Oncology
Kasturba Medical College
MAHE,Manipal
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
6369009530 |
| Fax |
|
| Email |
drjonathaneldad@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Karthik S Udupa |
| Designation |
Professor and unit head |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Medical Oncology
Kasturba Medical College
MAHE, Manipal
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9845317153 |
| Fax |
|
| Email |
udupa.karthik@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Jonathan Eldad E |
| Designation |
Senior Resident (DM Resident) |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Medical Oncology
Kasturba Medical College
MAHE, Manipal
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
6369009530 |
| Fax |
|
| Email |
drjonathaneldad@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College,
MAHE, Manipal
Udupi
Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
No sponsor for the study |
| Type of Sponsor |
Other [As it is a dietary study, no sponsor] |
|
|
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 Jonathan Eldad E |
Kasturba Medical College |
1st Floor, Dept. of Medical Oncology, Shirdi Saibaba Cancer Hospital and Research Centre, Kasturba Medical College, MAHE
Udupi
KARNATAKA |
6369009530
drjonathaneldad@yahoo.com |
|
|
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: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Personalized diet chart |
Participants in the intervention group will receive individualised dietary planning from a qualified dietician. The diet plan will be tailored based on calorie and protein requirements, BMI, physical activity, associated complications, and dietary preferences. The chart is designed according to the factor method and the 24-hour recall method. |
| Comparator Agent |
Standard of care |
Participants in the control group will receive standard care of our department which includes general dietary advice by the treating physician (oncologist) without personalized modifications. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Histologically confirmed Stage I–III breast cancer
Planned for adjuvant or neoadjuvant chemotherapy (AC chemotherapy)
ECOG performance status 0–2
Willing to follow a prescribed diet and participate in follow-ups
|
|
| ExclusionCriteria |
| Details |
Metastatic disease or terminal illness
Patient unfit for AC chemotherapy
On exclusive enteral/parenteral nutrition
Patient unwilling to participate in the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in fatigue levels assessed using the Fatigue Symptom Inventory before and after 2nd and 4th cycles of chemotherapy |
T 0- Baseline
T1- after 2 cycles of chemo
T2- after 4 cycles of chemo |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| diet adherence percentage and changes in anthropometric measurements, correlation between fatigue scores and anthropometric measures |
T 0- Baseline
T1- after 2 cycles of chemo
T2- after 4 cycles of chemo |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
28/11/2025 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
There is a paucity of prospective studies from the Indian population examining the direct impact of personalised dietary counselling and structured nutrition charts on fatigue scores among chemotherapy patients. Addressing this gap, the present study aims to evaluate whether targeted dietary modifications can serve as an effective non-pharmacological, supportive strategy to mitigate cancer-related fatigue and improve quality of life. Additionally, by incorporating anthropometric assessments, this study will objectively monitor changes in nutritional status, thereby providing a comprehensive understanding of the interplay between nutrition and fatigue. The findings may inform the development of integrative oncology care models in which nutrition is recognised as a core component of cancer management. |