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

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

NCT ID: NCT05938504

Condition: Colorectal Neoplasms

Conditions: Official terms:
Colorectal Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Other

Masking: Double (Participant, Investigator)

Intervention:

Intervention type: Other
Intervention name: ONS_320275
Description: Subjects will consume two packs (165ml/pack) of placebo ONS (ONS_320275) orally daily at any time of day.
Arm group label: Control group

Intervention type: Other
Intervention name: ONS_211567
Description: Subjects will consume two packs (165ml/pack) of test ONS (ONS_211567) orally daily at any time of day.
Arm group label: Test group

Summary: 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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 19 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Seoul St. Mary's hospital

Address:
City: Seoul
Zip: 06591
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Seunggyu Yoon

Phone: (+82) 02-2258-1511
Email: yoonsk@catholic.ac.kr

Investigator:
Last name: Ingyu Lee
Email: Principal Investigator

Start date: March 14, 2023

Completion date: February 28, 2025

Lead sponsor:
Agency: Daesang Wellife
Agency class: Industry

Collaborator:
Agency: Nutriworks
Agency class: Industry

Source: Daesang Wellife

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05938504