Status:
NOT_YET_RECRUITING
Evaluation of Safety and Efficacy of Three Flavors of Supportan® Drink in Cancer Patients in Taiwan
Lead Sponsor:
Fresenius Kabi Taiwan Ltd.
Conditions:
Cancer
Malnutrition (Calorie)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to demonstrate safety and efficacy of Supportan® Drink (three flavors:Tropical Fruits, Cappuccino, and Pineapple-Coconut), administered as oral nutritional supplemen...
Eligibility Criteria
Inclusion
- Patients receiving chemotherapy and/or radiotherapy, or immunotherapy, or targeted therapy;
- Patient with diagnosed cancer of any type (e.g., head and neck cancer, lung cancer, digestive tract cancer, breast cancer);
- Patient with or at risk of malnutrition defined as meeting Malnutrition Universal Screening Tool (MUST) with score ≥2;
- Capable of using oral nutritional supplementation;
- Written informed consent from patient.
Exclusion
- Patient with documented diagnosis of liver, kidney or heart disease in the hospital's electronic medical record (EMR); severity of disease evaluated by Investigator as not being suitable to participate in this study;
- Current alcohol or substance abuse as assessed by Investigator;
- Patient had a stroke in the past year and is after Investigator assessment judged as not yet clinically stable at the time of screening;
- Patients who are diagnosed with mental illness or depression assessed by the Investigator as too severe for being suitable to participate in this study;
- Pregnant or breastfeeding woman;
- Allergic to any ingredient of the investigational products;
- Patients receiving or having received standard (not disease specific) oral nutritional supplements (ONS), standard enteral formula/tube feeding or standard parenteral cancerspecific nutrition supplements in the last 3 days;
- Patients receiving or having received ONS, enteral formula/tube feeding or parenteral nutrition with high fish oil or high EPA/DHA content (above 1 g/day) in the last 28 days;
- Current use of medication, food supplements or ONS containing more than 500 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)/day or fish oil capsules/supplements containing more than 500 mg EPA and DHA/day at screening;
- Transfusion of blood products within 1 week before screening;
- Surgery scheduled during the trial;
- Participation in other clinical trials using investigational drugs within 14 days before the start of the trial or during the trial.
Key Trial Info
Start Date :
April 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT06902402
Start Date
April 14 2025
End Date
December 31 2025
Last Update
April 9 2025
Active Locations (1)
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1
Keelung Chang Gung Memorial Hospital-Lover's lake branch
Keelung, Taiwan, Taiwan, 204201