| CTRI Number |
CTRI/2025/12/099374 [Registered on: 18/12/2025] Trial Registered Prospectively |
| Last Modified On: |
27/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
Modification(s)
|
Effect of adding an oral concentrated liquid protein source to dietary counselling in epatients with breast and lung Cancer |
|
Scientific Title of Study
|
Comparing nutrient intake and quality of life in adults undergoing treatment for solid tumors, given either an oral nutritional protein supplement with dietary counselling or receiving dietary counselling alone (ProtiMedic- Onco). |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sankar Srinivasan |
| Designation |
Senior Consultant-Medical Oncologist |
| Affiliation |
Apollo Speciality Hospitals |
| Address |
Apollo Speciality Hospitals,
Department of Medical Oncology,
OPD Room no: 309, C block, 3rd floor,
New No.467, Old No.320, Padma Complex, Anna Salai,
Nandanam, Chennai-600035, Tamil Nadu.
Chennai TAMIL NADU 600035 India |
| Phone |
9940080233 |
| Fax |
|
| Email |
srinivasangirija@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sankar Srinivasan |
| Designation |
Senior Consultant-Medical Oncologist |
| Affiliation |
Apollo Speciality Hospitals |
| Address |
Apollo Speciality Hospitals,
Department of Medical Oncology,
OPD Room no: 309, C block, 3rd floor,
New No.467, Old No.320, Padma Complex, Anna Salai,
Nandanam, Chennai-600035, Tamil Nadu.
TAMIL NADU 600035 India |
| Phone |
9940080233 |
| Fax |
|
| Email |
srinivasangirija@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sankar Srinivasan |
| Designation |
Senior Consultant-Medical Oncologist |
| Affiliation |
Apollo Speciality Hospitals |
| Address |
Apollo Speciality Hospitals,
Department of Medical Oncology,
OPD Room no: 309, C block, 3rd floor,
New No.467, Old No.320, Padma Complex, Anna Salai,
Nandanam, Chennai-600035, Tamil Nadu.
TAMIL NADU 600035 India |
| Phone |
9940080233 |
| Fax |
|
| Email |
srinivasangirija@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dutch Medical Food India Private Limited |
|
|
Primary Sponsor
|
| Name |
Dutch Medical Food India Private Limited |
| Address |
Dutch Medical Food India Private Limited
Door No. 12/29, Plot No. 14/1 B, Ranjith Road, Kotturpuram
Chennai- 600 085 |
| Type of Sponsor |
Other [Neutraceuticals] |
|
|
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 |
| DrSankar Srinivasan |
Apollo Speciality Hospital |
Department of Medical Oncology,
OPD Room no: 309, C block, 3rd floor,
New No.467, Old No.320, Padma Complex, Anna Salai,
Nandanam, Chennai-600035, Tamil Nadu.
Chennai TAMIL NADU |
9940080233
srinivasangirija@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Biomedical Research, Apollo Hospitals, Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, (2) ICD-10 Condition: C30-C39||Malignant neoplasms of respiratory and intrathoracic organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dietary counselling |
Dietary Counselling
Duration 90 Days |
| Intervention |
Protimedic an oral Nutritional Supplematary and Dietary counselling |
Dose: Two 10 g protein in 20ml Sachets
Dosage form: Liquid
Frequency: Twice a Day BID
Duration: 90 Days |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with diagnosed solid tumors (stage 2 and stage 3)
2. Adults of both gender over 50 years with disease-related malnourished adults who undergo chemotherapy for solid tumor indications
3. Medium to a high degree of malnourishment, according to MUST criteria.
4. The subject must be able to eat and drink.
5. The subject must be ambulatory
6. The subject must be able to provide informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Subjects hospitalized for acute conditions impacting their metabolism.
2. Subjects with prostate cancer, leukemia, Blood cancer lymphoma, and recurrence.
3. Subjects with known allergies to Milk and Collagen
4. Subjects with chronic kidney disease requiring dialysis.
5. Subjects taking other forms of nutritional support.
6. Subjects with dysphagia, malabsorption or related GI disorders, poorly controlled diabetes, or liver failure, extreme malnutrition or anorexia.
7. Subjects with any disease state resulting in abnormal (high) A/G ratio.
8. Subjects receiving end-of-life care.
9. Subjects who are unable to provide informed consent.
10. Critically ill cancer patients.
|
|
|
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 protein intake from baseline to the end of the study period (12 weeks) in patients with solid tumors (Breast & Lung Cancer) receiving oral nutritional protein supplement with dietary counselling compared to dietary counselling alone. |
Day1, Day 28, Day 56, Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcomes include changes from baseline to the end of the study in total calorie intake, serum total protein levels, albumin–globulin (A/G) ratio, body weight, body mass index (BMI), hand grip strength, and quality of life as assessed using validated questionnaires (SF-36 and EORTC QLQ-C30). Treatment-related toxicities will also be assessed during the study period using NCI-CTCAE. |
Day 1, Day 28, Day 56, Day 84 |
|
|
Target Sample Size
|
Total Sample Size="126" Sample Size from India="126"
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)
|
10/02/2026 |
| 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="9" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Malnutrition is a common and significant concern among patients undergoing chemotherapy for solid tumors, particularly breast and lung cancer, and can adversely affect treatment tolerance, functional capacity, and quality of life. Regular assessment of nutritional status, including body weight, body mass index (BMI), and dietary intake, is essential for early identification and management of nutritional deficiencies. This study aims to explore and inform appropriate nutritional intervention strategies to improve the nutritional status, functional capacity, and quality of life of patients with solid tumors receiving chemotherapy. The primary objective of this study is to compare the effects of an oral nutritional protein supplement administered along with dietary counselling versus dietary counselling alone on protein intake. Secondary objectives include comparison of energy intake, total calorie intake, serum total protein levels, serum albumin to globulin (A/G) ratio, changes in body weight and BMI, hand grip strength assessed using a dynamometer, quality of life, and treatment-related toxicities. Energy and protein intake will be assessed at baseline and at weeks 4, 8, and 12 using a food diary provided by the study team. Blood samples collected at baseline and at the end of the study will be used to assess biochemical nutritional parameters, including serum protein and albumin–globulin ratio. Quality of life will be evaluated at baseline and during follow-up visits using validated questionnaires. Compliance will be assessed based on the proportion of the prescribed nutritional supplement consumed. Safety will be monitored at baseline and at each study visit until the end of the study through clinical assessments and documentation of adverse events. |