NCT06902402RecruitingNot Applicable
Evaluation of Safety and Efficacy of Supportan® Drink
Fresenius Kabi Taiwan Ltd.2 sites in 1 country135 target enrollmentStarted: April 8, 2025Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 135
- Locations
- 2
- Primary Endpoint
- Change in body weight from Baseline to end of treatment at Week 4 (Week 4 -Baseline)
Study Overview
Brief Summary
The goal of this clinical trial is to demonstrate safety and efficacy of Supportan® Drink
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •1. Patients receiving chemotherapy and/or radiotherapy, or immunotherapy, or targeted therapy;
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;
Arms & Interventions
Supportan® Drink
Experimental
Intervention: Supportan® Drink (Dietary Supplement)
Outcomes
Primary Outcomes
Change in body weight from Baseline to end of treatment at Week 4 (Week 4 -Baseline)
Time Frame: 4 weeks
Secondary Outcomes
- Change in CRP from Baseline to Week 2 and to end of treatment at Week 4 (Week 2 - Baseline, Week 4 - Baseline).(4 weeks)
- Change in body weight from Baseline to Week 2 (Week 2 - Baseline).(2 weeks)
- Change in BMI from Baseline to Week 2 and to end of treatment at Week 4 (Week 2 - Baseline, Week 4 - Baseline).(4 weeks)
- Change in calorie intake from Baseline to Week 2 and to end of treatment at Week 4 (Week 2 - Baseline, Week 4 - Baseline) using 3-day Dietary Records and additional intake of calories and protein from Supportan® Drink.(4 weeks)
- Investigational product (IP) treatment compliance rate (%) calculated from patient IP diaries.(4 weeks)
- Change in protein intake from Baseline to Week 2 and to end of treatment at Week 4 (Week 2 - Baseline, Week 4 - Baseline) using 3-day Dietary Records and additional intake of calories and protein from Supportan® Drink.(4 weeks)
Investigators
Study Sites (2)
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