An interventional study of ONS_320275 and ONS_211567 in Colorectal Neoplasms, sponsored by Daesang Wellife. Recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-07-10.
Sponsored by Daesang Wellife · Not applicable, Interventional, and Other
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.
5,598 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.
This study's planned enrollment of 154 is above the median of 77 across 4,122 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →This is the only study on the registry with Daesang Wellife as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A person who is diabetes mellitus with whose blood sugar is not controlled even when taking medication
A person diagnosed with hypertension whose blood pressure is not controlled even when taking medication
A person who is allergic or overreacting to the ingredients of a test product
Subjects will receive two packs of placebo ONS (ONS_320275) orally daily
Other: ONS_320275
Subjects will receive two packs of test ONS (ONS_211567) orally daily
Other: ONS_211567
Subjects will consume two packs (165ml/pack) of placebo ONS (ONS_320275) orally daily at any time of day.
Subjects will consume two packs (165ml/pack) of test ONS (ONS_211567) orally daily at any time of day.
Skeletal Muscle Index (SMI) change rate
Skeletal Muscle analysis is performed using BIA.
Time frame: Change rate from baseline Skeletal Muscle Index (SMI) at 12 weeks
Sarcopenia prevalence
Muscle reduction is determined by the researcher through SMM, HGS, and SPPB test results.
Time frame: Change from baseline Muscle reduction at 12 weeks
Skeletal muscle mass (SMM)
Skeletal muscle mass (SMM) analysis is performed using BIA.
Time frame: Change from baseline Skeletal muscle mass (SMM) at 12 weeks
Handgrip strength (HGS)
Handgrip strength (HGS) is an indicator of muscle strength.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Evaluating from 6 weeks to 12 weeks
Weight change and weight change rate
Weight analysis is performed using BIA.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Evaluating from 6 weeks to 12 weeks
Plan to share: No
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