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

Daesang Wellife

Status: Enrolling

Conditions: Colorectal Neoplasms

Treatments: Other: ONS_320275; Other: ONS_211567

Study type: Interventional

Funder types: Industry

Identifiers

NCT05938504

PROFIT

Details and patient eligibility

About

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.

Enrollment: 154 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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154 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

Subjects will receive two packs of placebo ONS (ONS_320275) orally daily

Treatment:

Other: ONS_320275

Test group

Experimental group

Description:

Subjects will receive two packs of test ONS (ONS_211567) orally daily

Treatment:

Other: ONS_211567