Colorectal NeoplasmsPROFITNCT05938504
Usefulness of Balanced High Protein Supplementation on Recovery and Clinical Outcomes After Chemotherapy
A study testing ONS_320275 and ONS_211567 in people with Colorectal Neoplasms, run by Daesang Wellife at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- ONS_320275 and ONS_211567
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Mar 2023to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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 locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul St. Mary's hospital
Seoul, 06591
Seunggyu Yoon, (+82) 02-2258-1511, yoonsk@catholic.ac.kr
Ingyu Lee
About this study
Official title: Usefulness of Balanced High Protein Supplementation on Recovery and Clinical Outcomes After Chemotherapy: Randomized, Parallel, Double-blind, Placebo-controlled Trial
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
- Being tested
- ONS_320275, ONS_211567
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONS_320275Other
Subjects will consume two packs (165ml/pack) of placebo ONS (ONS_320275) orally daily at any time of day.
ONS_211567Other
Subjects will consume two packs (165ml/pack) of test ONS (ONS_211567) orally daily at any time of day.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Subjects will receive two packs of placebo ONS (ONS_320275) orally daily Receives: Other: ONS_320275 |
| Test group | Experimental | Subjects will receive two packs of test ONS (ONS_211567) orally daily Receives: Other: ONS_211567 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal Muscle Index (SMI) change rate
Skeletal Muscle analysis is performed using BIA.
Measured: Change rate from baseline Skeletal Muscle Index (SMI) at 12 weeks
Secondary outcomes (12)
Sarcopenia prevalence
Muscle reduction is determined by the researcher through SMM, HGS, and SPPB test results.
Measured: Change from baseline Muscle reduction at 12 weeks
Skeletal muscle mass (SMM)
Skeletal muscle mass (SMM) analysis is performed using BIA.
Measured: Change from baseline Skeletal muscle mass (SMM) at 12 weeks
Handgrip strength (HGS)
Handgrip strength (HGS) is an indicator of muscle strength.
Measured: Change from baseline Handgrip strength (HGS) at 12 weeks
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.
Measured: Change from baseline Short physical performance battery (SPPB) at 12 weeks
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.
Measured: Evaluating from 6 weeks to 12 weeks
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).
Measured: Evaluating from 6 weeks to 12 weeks
Weight change and weight change rate
Weight analysis is performed using BIA.
Measured: Change from baseline weight change and weight change rate at 12 weeks
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)
Measured: Change from baseline immunity indicators at 12 weeks
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.
Measured: Change from baseline PG-SGA score at 12 weeks
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.
Measured: Change from baseline EORTC QLQ-C30 score at 12 weeks
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.
Measured: Change from baseline SNAQ score at 12 weeks
Oral nutritional supplement (ONS) sensory evaluation
Oral nutritional supplement (ONS) sensory evaluation is sensuality evaluation of test or control products.
Measured: Evaluating from 6 weeks to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start14 Mar 2023
- Primary completion31 Jul 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daesang Wellife
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutriworks
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938504
- Sponsor's protocol ID
- PROFIT
- Acronym
- PROFIT
- Status last verified
- Jul 2023
- First submitted
- 12 Jun 2023
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Balanced High Protein Supplementation on Recovery and Clinical Outcomes After Chemotherapy: Randomized, Parallel, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05938504
- Acronym / sponsor ID
- PROFIT / PROFIT
- Conditions
- Colorectal Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Daesang WellifeIndustry (pharma, biotech, devices)
- Collaborators
- Nutriworks
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: ONS_320275Subjects will receive two packs of placebo ONS (ONS_320275) orally daily |
| Test group | Experimental | Other: ONS_211567Subjects will receive two packs of test ONS (ONS_211567) orally daily |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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
- A person diagnosed with hypertension whose blood pressure is not controlled even when taking 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONS_320275Subjects will consume two packs (165ml/pack) of placebo ONS (ONS_320275) orally daily at any time of day. | Other | Control group |
| ONS_211567Subjects will consume two packs (165ml/pack) of test ONS (ONS_211567) orally daily at any time of day. | Other | Test group |
Primary outcome
Skeletal Muscle Index (SMI) change rate
Time frame: Change rate from baseline Skeletal Muscle Index (SMI) at 12 weeks
Skeletal Muscle analysis is performed using BIA.
12 secondary outcomes
Sarcopenia prevalence
Time frame: Change from baseline Muscle reduction at 12 weeks
Skeletal muscle mass (SMM)
Time frame: Change from baseline Skeletal muscle mass (SMM) at 12 weeks
Handgrip strength (HGS)
Time frame: Change from baseline Handgrip strength (HGS) at 12 weeks
Short physical performance battery (SPPB)
Time frame: Change from baseline Short physical performance battery (SPPB) at 12 weeks
Common terminology criteria for adverse events (CTCAE) 5.0
Time frame: Evaluating from 6 weeks to 12 weeks
Incidence of chemotherapy modification
Time frame: Evaluating from 6 weeks to 12 weeks
Weight change and weight change rate
Time frame: Change from baseline weight change and weight change rate at 12 weeks
Detection of immunity indicators in blood samples drawn from a vein
Time frame: Change from baseline immunity indicators at 12 weeks
Nutritional status evaluation and intake evaluation (PG-SGA)
Time frame: Change from baseline PG-SGA score at 12 weeks
Quality of life (EORTC QLQ-C30)
Time frame: Change from baseline EORTC QLQ-C30 score at 12 weeks
Simplified nutritional appetite questionnaire (SNAQ)
Time frame: Change from baseline SNAQ score at 12 weeks
Oral nutritional supplement (ONS) sensory evaluation
Time frame: Evaluating from 6 weeks to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ONS_320275 and ONS_211567 in people with Colorectal Neoplasms, run by Daesang Wellife at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joo Hyun Park ((+82) 80-996-6262, jhpark3@daesang.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal Muscle Index (SMI) change rate (time frame: Change rate from baseline Skeletal Muscle Index (SMI) at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.