A study to evaluate the effect of nutritional supplement on weakness in cancer patients undergoing chemotherapy and/or radiotherapy
- Conditions
- Health Condition 1: E639- Nutritional deficiency, unspecified
- Registration Number
- CTRI/2020/11/029409
- Lead Sponsor
- Dr Reddys Laboratories Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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) � 17.00 to � 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 � Grade 2.
8. Acceptable hematology status:
a. Hemoglobin � 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) � 2.0 X ULN
b. Aspartate aminotransferase (AST) � 2.0 X ULN
c. Bilirubin < 1.2 mg/dL
d. Alkaline phosphatase � 2.0 X ULN
10. Patients with creatinine clearance � 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.
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method