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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 supplement, that will be taken in addition to the patient's normal dietary intake to meet the daily nutritional targets. in cancer patients. The main questions it aims to answer are:
Primary Efficacy Endpoint 1. Change in body weight from Baseline to end of treatment at Week 4 (Week 4 -Baseline) Secondary Efficacy Endpoints
1. Change in CRP from Baseline to Week 2 and to end of treatment at Week 4 (Week 2 - Baseline, Week 4 -Baseline)
Participants will be enrolled in one of three flavor group by his/her recruiting time. Each subject needs visit hospital at baseline, week 2 and week 4 for checkups and test. And he/she needs take two bottles of Supportan Drink per day. During the study periods, subjects need write down his/her dietary records every day for evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportan® Drink | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supportan® Drink, flavour Tropical Fruits | Dietary Supplement | flavour Tropical Fruits |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight from Baseline to end of treatment at Week 4 (Week 4 -Baseline) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keelung Chang Gung Memorial Hospital-Lover's lake branch | Keelung | Taiwan | 204201 | Taiwan |
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| Supportan® Drink, flavour Cappuccino |
| Dietary Supplement |
flavour Cappuccino |
|
| Supportan® Drink, flavour Pineapple-Coconut | Dietary Supplement | flavour Pineapple-Coconut |
|
| 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 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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