Health Condition 1: E639- Nutritional deficiency, unspecified
Conditions
Interventions
Intervention1: Energy dense protein supplement: One sachet (33gm) of energy dense oral protein supplement powder with immune nutrients will be given twice a day to each patient with lukewarm water for
Sponsors
Dr Reddys Laboratories Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient willing and able to provide voluntary informed consent and to follow the protocol requirements. 2. Male or female aged at least 18 years or older and having Body mass index (BMI) â�¥ 17.00 to â�¤ 24.9 (both inclusive) calculated as weight in kg/height in m 2 3. Patient suffering from head and neck or gastrointestinal or lung cancer confirmed by histopathological report. 4. Patient undergoing radiotherapy and/or chemotherapy or post-operative patients. 5. Patient suffering from weight loss in past 6 months based on the SGA score (either B or C). 6. Patient who has a life expectancy of at least 6 months. 7. ECOG performance status of â�¤ Grade 2. 8. Acceptable hematology status: a. Hemoglobin â�¥ 9.0 g/dL b. Absolute neutrophil count (ANC) â�¥ 1500 cells/�µL c. Platelet count â�¥ 1,00,000 cells/�µL 9. Acceptable liver function: a. Alanine aminotransferase (ALT) â�¤ 2.0 X ULN b. Aspartate aminotransferase (AST) â�¤ 2.0 X ULN c. Bilirubin d. Alkaline phosphatase â�¤ 2.0 X ULN 10. Patients with creatinine clearance â�¥ 60 mL/minute. 11. Patients with negative urine pregnancy test at screening. 12. Women of child bearing potential, (defined as women physiologically capable of becoming pregnant, unless they are using effective method of contraception during dosing of the investigational product) practicing any acceptable methods of contraception. 13. No history of addiction to any recreational drug or drug dependence or alcohol addiction.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity or contraindication to any of the ingredients of the Investigational product. 2. Current or past history of, severe hepatic or renal impairment. 3. History or presence of any uncontrolled systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus, hepatic impairment etc.) 4. Patient having pre-existing intestinal diseases other than malignancy. 5. Patients with psychiatric disorder. 6. Patients suffering from dehydration and edema. 7. Patient unable to take medication orally. 8. Patient with other active medical condition or another malignancy. 9. Patient with known CNS metastases. 10. Major surgical procedure (including periodontal) planned within 90 days of first dose of investigational product. 11. Patients taking prescription medications intended to increase appetite, increase muscle mass or treat weight loss. 12. Patients consuming any other protein product in the form of powders or beverages 13. Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the patient to participate in the study that would limit adherence to study requirements. 14. Participation in any clinical study within 90 days before the first dose of investigational product. 15. Pregnant or lactating woman. 16. Patient with a Coronavirus infection (COVID-19).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in muscle strength measured by hand grip dynamometer to evaluate individual muscle strengthTimepoint: Day 1 to Day 91 | — |
Secondary
| Measure | Time frame |
|---|---|
| C-reactive protein levels to evaluate inflammatory parameter and oxidative stressTimepoint: Baseline (screening) to Day 30, 60 and 91;Change in acute phase proteins (albumin and pre-albumin) to evaluate individual protein status.Timepoint: From baseline(screening) to Day 30, 60 and 91;Change in Eastern Cooperative Oncology Group (ECOG) performance scoresTimepoint: Baseline (screening) to Day 1 and 91;Change in Glasgow prognostic score (GPS) (calculated based on CRP level and albumin level)Timepoint: Day 1 to Day 30, 60 and 91;Change in Immunity marker (ALC)Timepoint: Baseline (screening) to Day 30, 60 and 91;Change in muscle strength measured by hand grip dynamometer/strength to evaluate individual muscle strengthTimepoint: Day 1 to Day 30 and Day 60;Change in nutritional status (dietary intake)Timepoint: 1 week before treatment and 1 week before end of study;Patient satisfaction by tolerability testing of the investigational productTimepoint: Day 1 to Day 30 and Day 60;Weight Gain to evaluate weight and muscle massTimepoint: Day 1 to Day 30, 60 and 91 | — |
Countries
India
Contacts
Public ContactColette Pinto
Dr. Reddys Laboratories Ltd.
Outcome results
None listed