Clinical trial NCT05938504: Usefulness of Balanced High Protein Supplementation on Recovery and Clinical Outcomes After Chemotherapy
Official title: Usefulness of Balanced High Protein Supplementation on Recovery and Clinical Outcomes After Chemotherapy: Randomized, Parallel, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Neoplasms
Lead sponsor: Daesang Wellife
Sponsor class: INDUSTRY
Collaborators: name: Nutriworks
First posted: 2023-07-10
Enrollment: 154
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Skeletal Muscle Index (SMI) change rate
timeFrame: Change rate from baseline Skeletal Muscle Index (SMI) at 12 weeks
Secondary outcomes:
measure: Sarcopenia prevalence
timeFrame: Change from baseline Muscle reduction at 12 weeks
measure: Skeletal muscle mass (SMM)
timeFrame: Change from baseline Skeletal muscle mass (SMM) at 12 weeks
measure: Handgrip strength (HGS)
timeFrame: Change from baseline Handgrip strength (HGS) at 12 weeks
measure: Short physical performance battery (SPPB)
timeFrame: Change from baseline Short physical performance battery (SPPB) at 12 weeks
measure: Common terminology criteria for adverse events (CTCAE) 5.0
timeFrame: Evaluating from 6 weeks to 12 weeks
measure: Incidence of chemotherapy modification
timeFrame: Evaluating from 6 weeks to 12 weeks
measure: Weight change and weight change rate
timeFrame: Change from baseline weight change and weight change rate at 12 weeks
measure: Detection of immunity indicators in blood samples drawn from a vein
timeFrame: Change from baseline immunity indicators at 12 weeks
measure: Nutritional status evaluation and intake evaluation (PG-SGA)
timeFrame: Change from baseline PG-SGA score at 12 weeks
measure: Quality of life (EORTC QLQ-C30)
timeFrame: Change from baseline EORTC QLQ-C30 score at 12 weeks
measure: Simplified nutritional appetite questionnaire (SNAQ)
timeFrame: Change from baseline SNAQ score at 12 weeks
measure: Oral nutritional supplement (ONS) sensory evaluation
timeFrame: Evaluating from 6 weeks to 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's hospital
Study officials:
References: