Status:
UNKNOWN
Effect of NUTRICAN to Improve Nutritional Status in Cancer Patients
Lead Sponsor:
Kalbe International Pte. Ltd
Collaborating Sponsors:
Persahabatan Hospital
Conditions:
Malnutrition; Protein
Cancer, Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The goal of this clinical trial is to evaluate the efficacy oral nutrition supplement (ONS) in malnutrition/high risk malnutrition cancer patients. The main questions it aims to answer: 1. Are there ...
Detailed Description
This study uses an open label randomized clinical trial (RCT) design, double arm which allows subjects and researchers to know the interventions received by subjects conducted on cancer patient subjec...
Eligibility Criteria
Inclusion
- Histologically confirmed lung and ob-gyn cancer patients (who have not undergone therapy or are currently undergoing therapy)
- Aged greater than or equal to 18 years
- Patients with a performance status score of 0 - 2
- Have inadequate food intake \>5 days or:
- BMI/body mass index \<18.5 kg/m2 or
- There is a \>10% weight loss in the last 3-6 months or
- BMI \<20 kg/m2 or
- There is \>5% weight loss in the last 3-6 months with
- Intervention group subjects are willing to take ONS orally for 8 weeks
- Intervention group subjects, if they have taken other brands of ONS, are willing to stop taking ONS 2 weeks prior to the study.
Exclusion
- Pregnant and breastfeeding, except for female subjects with one of the following criteria:
- Have a history of hysterectomy (surgical removal of the uterus) and/or bilateral oophorectomy (surgical removal of the ovaries).
- Medically confirmed ovarian failure (decreased ovarian function)
- Achieved post menopausal status, defined as: cessation of regular menstruation for at least 12 consecutive months in the absence of pathological or physiological causes.
- Renal insufficiency (eGFR ( Estimated Glomerular Filtration Rate ) \<15 mL/min/1.73 m2 or significant increase in urea/creatinine or having to be on a low protein diet)
- Liver insufficiency (SGOT (Serum Glutamic Oxaloacetic Transaminase) /SGPT (Serum Glutamic Pyruvic Transaminase) values ≥3 times the normal limit)
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2024
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT06128694
Start Date
August 1 2023
End Date
August 30 2024
Last Update
July 30 2024
Active Locations (1)
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1
Persahabatan General Hospital
Jakarta, Indonesia, 13230