Evaluation of Safety and Efficacy of Three Flavors of Supportan® Drink in Cancer Patients in Taiwan

Launched by FRESENIUS KABI TAIWAN LTD. · Mar 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a nutritional drink called Supportan® in cancer patients who may be at risk of malnutrition. The trial will include participants aged 65 to 74 who are receiving treatments like chemotherapy or immunotherapy for any type of cancer. To be eligible, patients must show signs of malnutrition based on a simple screening tool. Over four weeks, participants will drink two bottles of Supportan® each day, along with their regular meals, and will visit the hospital for checkups at the start, after two weeks, and at the end of the study.

During the trial, participants will keep a daily record of what they eat to help researchers evaluate how well the drink works. The main goals are to see if drinking Supportan® helps patients gain weight and improve their overall health. It’s important to note that patients with certain health issues, like severe heart or liver problems, or those who are pregnant or breastfeeding, cannot participate in the study. If you're interested in learning more, please talk to your healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients receiving chemotherapy and/or radiotherapy, or immunotherapy, or targeted therapy;
• • 2. Patient with diagnosed cancer of any type (e.g., head and neck cancer, lung cancer, digestive tract cancer, breast cancer);
• • 3. Patient with or at risk of malnutrition defined as meeting Malnutrition Universal Screening Tool (MUST) with score ≥2;
• • 4. Capable of using oral nutritional supplementation;
• • 5. Written informed consent from patient.
• Exclusion Criteria:
• • 1. 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;
• • 2. Current alcohol or substance abuse as assessed by Investigator;
• • 3. Patient had a stroke in the past year and is after Investigator assessment judged as not yet clinically stable at the time of screening;
• • 4. Patients who are diagnosed with mental illness or depression assessed by the Investigator as too severe for being suitable to participate in this study;
• • 5. Pregnant or breastfeeding woman;
• • 6. Allergic to any ingredient of the investigational products;
• • 7. 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;
• • 8. 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;
• • 9. 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;
• • 10. Transfusion of blood products within 1 week before screening;
• • 11. Surgery scheduled during the trial;
• • 12. Participation in other clinical trials using investigational drugs within 14 days before the start of the trial or during the trial.