Balanced high protein supplements for recovery after chemotherapy
Usefulness of Balanced High Protein Supplementation on Recovery and Clinical Outcomes After Chemotherapy: Randomized, Parallel, Double-blind, Placebo-controlled Trial
This study is testing whether high protein supplements can help people recovering from chemotherapy for colorectal cancer regain muscle strength and improve their overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 154 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Daesang Wellife Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05938504 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of balanced high protein supplementation on muscle function recovery and overall clinical outcomes in patients undergoing chemotherapy for colorectal cancer. Participants will receive either the test nutritional supplements or a placebo, allowing researchers to compare the results between the two groups. The study focuses on assessing improvements in muscle function and other health metrics post-chemotherapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 or older diagnosed with colorectal cancer who are about to begin chemotherapy.
Not a fit: Patients with a history of cancer, uncontrolled diabetes, hypertension, or significant renal or liver dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance recovery and improve quality of life for patients undergoing chemotherapy.
How similar studies have performed: While the specific approach of balanced high protein supplementation is being evaluated here, similar nutritional interventions have shown promise in enhancing recovery in other cancer treatment contexts.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Seoul St. Mary's hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Joo Hyun Park
- Email: jhpark3@daesang.com
- Phone: (+82) 80-996-6262
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.