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

Daesang Wellife154 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

154

Conditions

Colorectal Neoplasms

Interventions

ONS_320275OTHER

Subjects will consume two packs (165ml/pack) of placebo ONS (ONS\_320275) orally daily at any time of day.

ONS_211567OTHER

Subjects will consume two packs (165ml/pack) of test ONS (ONS\_211567) orally daily at any time of day.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul St. Mary's hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

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).

Central Contacts

Joo Hyun Park

CONTACT

(+82) 80-996-6262 jhpark3@daesang.com

Data from ClinicalTrials.gov

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