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

September 1, 2026 updated by: Fresenius Kabi Taiwan Ltd.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
123

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Taiwan
      • Keelung, Taiwan, Taiwan, 204201
        • Keelung Chang Gung Memorial Hospital-Lover's lake branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Supportan® Drink
Dietary supplement: Supportan® Drink, flavour Tropical Fruits
flavour Tropical Fruits
Dietary supplement: Supportan® Drink, flavour Cappuccino
flavour Cappuccino
Dietary supplement: Supportan® Drink, flavour Pineapple-Coconut
flavour Pineapple-Coconut

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in body weight from Baseline to end of treatment at Week 4 (Week 4 -Baseline)
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in CRP from Baseline to Week 2 and to end of treatment at Week 4 (Week 2 - Baseline, Week 4 - Baseline).
Time Frame: 4 weeks
4 weeks
Change in body weight from Baseline to Week 2 (Week 2 - Baseline).
Time Frame: 2 weeks
2 weeks
Change in BMI from Baseline to Week 2 and to end of treatment at Week 4 (Week 2 - Baseline, Week 4 - Baseline).
Time Frame: 4 weeks
4 weeks
Investigational product (IP) treatment compliance rate (%) calculated from patient IP diaries.
Time Frame: 4 weeks
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.
Time Frame: 4 weeks
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.
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fresenius Kabi Taiwan Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 8, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 12, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 12, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Supp-015-CEN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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