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

NCT05938504 | Unknown DMC

• 1 other identifier: PROFIT
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Sarcopenia prevalence

  Change from baseline Muscle reduction at 12 weeks

• Skeletal muscle mass (SMM)

  Change from baseline Skeletal muscle mass (SMM) at 12 weeks

• Handgrip strength (HGS)

  Change from baseline Handgrip strength (HGS) at 12 weeks

• Short physical performance battery (SPPB)

  Change from baseline Short physical performance battery (SPPB) at 12 weeks

• Common terminology criteria for adverse events (CTCAE) 5.0

  Evaluating from 6 weeks to 12 weeks

Study Arms (2)

Control group

PLACEBO COMPARATOR

Subjects will receive two packs of placebo ONS (ONS\_320275) orally daily

Other: ONS_320275

Test group

EXPERIMENTAL

Subjects will receive two packs of test ONS (ONS\_211567) orally daily

Other: ONS_211567

Interventions

ONS_320275 OTHER

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

Control group

ONS_211567 OTHER

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

Test group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daesang Wellife: lead
• Nutriworks: collaborator

Study Sites (1)

Seoul St. Mary's hospital

Seoul, 06591, South Korea

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Joo Hyun Park

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: July 10, 2023
• Study Start: March 14, 2023
• Primary Completion: July 31, 2024
• Study Completion: February 28, 2025
• Last Updated: July 10, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)