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

Primary Purpose

Colorectal Neoplasms

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ONS_320275
ONS_211567
Sponsored by
Daesang Wellife
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Colorectal Neoplasms

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul St. Mary's hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control group

Test group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Skeletal Muscle Index (SMI) change rate
Skeletal Muscle analysis is performed using BIA.

Secondary Outcome Measures

Sarcopenia prevalence
Muscle reduction is determined by the researcher through SMM, HGS, and SPPB test results.
Skeletal muscle mass (SMM)
Skeletal muscle mass (SMM) analysis is performed using BIA.
Handgrip strength (HGS)
Handgrip strength (HGS) is an indicator of muscle strength.
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.
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.
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).
Weight change and weight change rate
Weight analysis is performed using BIA.
Detection of immunity indicators in blood samples drawn from a vein
Detection and quantification of immunity indicators in blood samples drawn from a vein : Interleukin-6 (IL-6), Interleukin 10 (IL-10), Interleukin 17 (IL-17), Interleukin-2 (IL-2), Interleukin-12 (IL-12), Interferon gamma (IFN-γ), Tumor necrosis factor-alpha (TNF-α)
Nutritional status evaluation and intake evaluation (PG-SGA)
Nutritional status evaluation and intake evaluation (PG-SGA) is a tool that expresses nutritional status. It is divided into continuous and categorical variables. In continuous variable, 0 to 1 point is said to be good according to the total score, and 2 to 3, 4 to 8, and 9 or more points are evaluated as 3 phases of malnutrition. In categorical variable, it consists of three types: A, B, and C, and the results deteriorate in order.
Quality of life (EORTC QLQ-C30)
Quality of life (EORTC QLQ-C30) is developed to assess the quality of life of cancer patients. Each questions 1 through 28 have a maximum of 4 point and a minimum of 1 point, and each questions 29 through 30 have a maximum of 7 point and a minimum of 1 point. The former means higher scores is worse results, and the latter means higher scores is better results. The total score is 0 to 100 points.
Simplified nutritional appetite questionnaire (SNAQ)
Simplified nutritional appetite questionnaire (SNAQ) is a simple appetite scale assessment tool that has been validated to predict weight loss in cancer patients. Including all the questions, each question's maximum score is 5 point and the minimum score is 1 point. A lower score means worse results. The total score is 4 to 20 points.
Oral nutritional supplement (ONS) sensory evaluation
Oral nutritional supplement (ONS) sensory evaluation is sensuality evaluation of test or control products.

Full Information

First Posted
June 12, 2023
Last Updated
July 4, 2023
Sponsor
Daesang Wellife
Collaborators
Nutriworks
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1. Study Identification

Unique Protocol Identification Number
NCT05938504
Brief Title
Usefulness of Balanced High Protein Supplementation on Recovery and Clinical Outcomes After Chemotherapy
Acronym
PROFIT
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2023 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
February 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daesang Wellife
Collaborators
Nutriworks

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
154 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Subjects will receive two packs of placebo ONS (ONS_320275) orally daily
Arm Title
Test group
Arm Type
Experimental
Arm Description
Subjects will receive two packs of test ONS (ONS_211567) orally daily
Intervention Type
Other
Intervention Name(s)
ONS_320275
Intervention Description
Subjects will consume two packs (165ml/pack) of placebo ONS (ONS_320275) orally daily at any time of day.
Intervention Type
Other
Intervention Name(s)
ONS_211567
Intervention Description
Subjects will consume two packs (165ml/pack) of test ONS (ONS_211567) orally daily at any time of day.
Primary Outcome Measure Information:
Title
Skeletal Muscle Index (SMI) change rate
Description
Skeletal Muscle analysis is performed using BIA.
Time Frame
Change rate from baseline Skeletal Muscle Index (SMI) at 12 weeks
Secondary Outcome Measure Information:
Title
Sarcopenia prevalence
Description
Muscle reduction is determined by the researcher through SMM, HGS, and SPPB test results.
Time Frame
Change from baseline Muscle reduction at 12 weeks
Title
Skeletal muscle mass (SMM)
Description
Skeletal muscle mass (SMM) analysis is performed using BIA.
Time Frame
Change from baseline Skeletal muscle mass (SMM) at 12 weeks
Title
Handgrip strength (HGS)
Description
Handgrip strength (HGS) is an indicator of muscle strength.
Time Frame
Change from baseline Handgrip strength (HGS) at 12 weeks
Title
Short physical performance battery (SPPB)
Description
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
Title
Common terminology criteria for adverse events (CTCAE) 5.0
Description
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
Title
Incidence of chemotherapy modification
Description
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).
Time Frame
Evaluating from 6 weeks to 12 weeks
Title
Weight change and weight change rate
Description
Weight analysis is performed using BIA.
Time Frame
Change from baseline weight change and weight change rate at 12 weeks
Title
Detection of immunity indicators in blood samples drawn from a vein
Description
Detection and quantification of immunity indicators in blood samples drawn from a vein : Interleukin-6 (IL-6), Interleukin 10 (IL-10), Interleukin 17 (IL-17), Interleukin-2 (IL-2), Interleukin-12 (IL-12), Interferon gamma (IFN-γ), Tumor necrosis factor-alpha (TNF-α)
Time Frame
Change from baseline immunity indicators at 12 weeks
Title
Nutritional status evaluation and intake evaluation (PG-SGA)
Description
Nutritional status evaluation and intake evaluation (PG-SGA) is a tool that expresses nutritional status. It is divided into continuous and categorical variables. In continuous variable, 0 to 1 point is said to be good according to the total score, and 2 to 3, 4 to 8, and 9 or more points are evaluated as 3 phases of malnutrition. In categorical variable, it consists of three types: A, B, and C, and the results deteriorate in order.
Time Frame
Change from baseline PG-SGA score at 12 weeks
Title
Quality of life (EORTC QLQ-C30)
Description
Quality of life (EORTC QLQ-C30) is developed to assess the quality of life of cancer patients. Each questions 1 through 28 have a maximum of 4 point and a minimum of 1 point, and each questions 29 through 30 have a maximum of 7 point and a minimum of 1 point. The former means higher scores is worse results, and the latter means higher scores is better results. The total score is 0 to 100 points.
Time Frame
Change from baseline EORTC QLQ-C30 score at 12 weeks
Title
Simplified nutritional appetite questionnaire (SNAQ)
Description
Simplified nutritional appetite questionnaire (SNAQ) is a simple appetite scale assessment tool that has been validated to predict weight loss in cancer patients. Including all the questions, each question's maximum score is 5 point and the minimum score is 1 point. A lower score means worse results. The total score is 4 to 20 points.
Time Frame
Change from baseline SNAQ score at 12 weeks
Title
Oral nutritional supplement (ONS) sensory evaluation
Description
Oral nutritional supplement (ONS) sensory evaluation is sensuality evaluation of test or control products.
Time Frame
Evaluating from 6 weeks to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joo Hyun Park
Phone
(+82) 80-996-6262
Email
jhpark3@daesang.com
Facility Information:
Facility Name
Seoul St. Mary's hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seunggyu Yoon
Phone
(+82) 02-2258-1511
Email
yoonsk@catholic.ac.kr
First Name & Middle Initial & Last Name & Degree
Ingyu Lee

12. IPD Sharing Statement

Plan to Share IPD
No

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

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