Usefulness of Balanced High Protein Supplementation on Recovery and Clinical Outcomes After Chemotherapy

Study Overview
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Brief Summary
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The goal of this clinical trial is to find usefulness of balanced high protein supplementation on muscle function recovery and clinical outcomes after chemotherapy. Participants will intake test or placebo oral nutritional supplements. Researchers will compare test groups and placebo groups to see if test oral supplements are more useful in muscle function recovery and clinical outcomes.

Official Title
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Usefulness of Balanced High Protein Supplementation on Recovery and Clinical Outcomes After Chemotherapy: Randomized, Parallel, Double-blind, Placebo-controlled Trial

Conditions
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Colorectal Neoplasms

Intervention / Treatment
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* Other: ONS_320275
* Other: ONS_211567


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A person aged 19 or older A person who is diagnosed with direct colorectal cancer and begins chemotherapy A person who voluntarily agreed to participate in this trial and signed a informed consent form Exclusion Criteria: A person who has previously been diagnosed with cancer A person with a BMI of 30.0 kg/m2 or more A person who is diabetes mellitus with whose blood sugar is not controlled even when taking medication More than 126mg/dL of fasting blood sugar even on diabetes medication A person diagnosed with hypertension whose blood pressure is not controlled even when taking medication Systolic blood pressure 160mmHg or diastolic blood pressure 100mmHg or higher even when taking hypertension medication A person with renal dysfunction (up 1.5 times the upper limit of Creatinine normal) and liver dysfunction (up 2.5 times the upper limit of AST and ALT normal) A person with a serious musculoskeletal problem A person who has been diagnosed with acute or serious diseases (e.g., liver, kidney, heart, thyroid disease, etc.) or is on medication A person who has continuously taken health functional foods related to the ability to perform exercise within three months before visiting (Hormones, muscle enhancers, protein supplementation and muscle function improvement) A person who is allergic or overreacting to the ingredients of a test product All ingredients of the test product shall be specified in the consent form, and all ingredients that may cause allergies, such as sodium casein, shall be checked during screening A person who has participated in another clinical trial or a drug clinical trial within one month of the commencement of this test A person who is illiterate or whose ability is limited A person who is pregnant or lactating A person judged inappropriate by a researcher to participate in this study for other reasons

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>Subjects will receive two packs of placebo ONS (ONS_320275) orally daily | Other: ONS_320275<br>* Subjects will consume two packs (165ml/pack) of placebo ONS (ONS_320275) orally daily at any time of day.<br>|
| Experimental: Test group<br>Subjects will receive two packs of test ONS (ONS_211567) orally daily | Other: ONS_211567<br>* Subjects will consume two packs (165ml/pack) of test ONS (ONS_211567) orally daily at any time of day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skeletal Muscle Index (SMI) change rate | Skeletal Muscle analysis is performed using BIA. | Change rate from baseline Skeletal Muscle Index (SMI) at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sarcopenia prevalence | Muscle reduction is determined by the researcher through SMM, HGS, and SPPB test results. | Change from baseline Muscle reduction at 12 weeks | 
| Skeletal muscle mass (SMM) | Skeletal muscle mass (SMM) analysis is performed using BIA. | Change from baseline Skeletal muscle mass (SMM) at 12 weeks | 
| Handgrip strength (HGS) | Handgrip strength (HGS) is an indicator of muscle strength. | Change from baseline Handgrip strength (HGS) at 12 weeks | 
| Short physical performance battery (SPPB) | Short physical performance battery (SPPB) is a multi-function evaluation that combines three useful and easy-to-measure objective functional evaluation methods. | Change from baseline Short physical performance battery (SPPB) at 12 weeks | 
| Common terminology criteria for adverse events (CTCAE) 5.0 | Common Terminology Criteria for Adverse Events (CTCAE) is widely accepted as the standard classification and severity grading scale for adverse events in cancer therapy, clinical trials and other oncology settings. Version 5.0 is the most updated document. | Evaluating from 6 weeks to 12 weeks | 
| Incidence of chemotherapy modification | Incidence of chemotherapy modification is classified into delayed administration, dose reduction, and administration termination of anticancer drugs, and investigated on a dichotomy scale (existence or absence). | Evaluating from 6 weeks to 12 weeks | 
| Weight change and weight change rate | Weight analysis is performed using BIA. | Change from baseline weight change and weight change rate at 12 weeks | 
| Detection of immunity indicators in blood samples drawn from a vein | Detection and quantification of immunity indicators in blood samples drawn from a vein : Interleukin-6 (IL-6), Interleukin 10 (IL-10), Interleukin 17 (IL-17), Interleukin-2 (IL-2), Interleukin-12 (IL-12), Interferon gamma (IFN-γ), Tumor necrosis factor-alpha (TNF-α) | Change from baseline immunity indicators at 12 weeks | 
| Nutritional status evaluation and intake evaluation (PG-SGA) | Nutritional status evaluation and intake evaluation (PG-SGA) is a tool that expresses nutritional status. It is divided into continuous and categorical variables. In continuous variable, 0 to 1 point is said to be good according to the total score, and 2 to 3, 4 to 8, and 9 or more points are evaluated as 3 phases of malnutrition. In categorical variable, it consists of three types: A, B, and C, and the results deteriorate in order. | Change from baseline PG-SGA score at 12 weeks | 
| Quality of life (EORTC QLQ-C30) | Quality of life (EORTC QLQ-C30) is developed to assess the quality of life of cancer patients. Each questions 1 through 28 have a maximum of 4 point and a minimum of 1 point, and each questions 29 through 30 have a maximum of 7 point and a minimum of 1 point. The former means higher scores is worse results, and the latter means higher scores is better results. The total score is 0 to 100 points. | Change from baseline EORTC QLQ-C30 score at 12 weeks | 
| Simplified nutritional appetite questionnaire (SNAQ) | Simplified nutritional appetite questionnaire (SNAQ) is a simple appetite scale assessment tool that has been validated to predict weight loss in cancer patients. Including all the questions, each question's maximum score is 5 point and the minimum score is 1 point. A lower score means worse results. The total score is 4 to 20 points. | Change from baseline SNAQ score at 12 weeks | 
| Oral nutritional supplement (ONS) sensory evaluation | Oral nutritional supplement (ONS) sensory evaluation is sensuality evaluation of test or control products. | Evaluating from 6 weeks to 12 weeks |