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Effect of adding an oral concentrated liquid protein source to dietary counselling in epatients with breast and lung Cancer

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). - Nil

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/099374
Enrollment
126
Registered
2025-12-18
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C50- Malignant neoplasm of breast Health Condition 2: C30-C39- Malignant neoplasms of respiratory and intrathoracic organs

Interventions

Intervention1: 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 Control Inte

Sponsors

Dutch Medical Food India Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.Timepoint: Day1, Day 28, Day 56, Day 84—

Secondary

MeasureTime frame
Secondary outcomes include changes from baseline to the end of the study in total calorie intake, serum total protein levels, albuminâ??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.Timepoint: Day 1, Day 28, Day 56, Day 84—

Countries

India

Contacts

Public ContactDr Sankar Srinivasan

Apollo Speciality Hospitals

srinivasangirija@gmail.com9940080233

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026