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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  
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 
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  
Status 
Not Applicable 
 
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.

 
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