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Trial Title:
the Safety and Effectiveness of Protein Supplements on Cancer Patients With Nutritional Risk and Malnutrition
NCT ID:
NCT05802381
Condition:
Cancer
Malnutrition
Conditions: Official terms:
Malnutrition
Conditions: Keywords:
protein
malnutrition
nutritional risk
cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
protein supplement
Description:
20 gram protein supplement per day
Arm group label:
protein supplements
Other name:
protein
Intervention type:
Behavioral
Intervention name:
nutrition counseling
Description:
nutrition counseling for guidance of food intake
Arm group label:
dietary guidance
Arm group label:
protein supplements
Summary:
Nutritional risk and malnutrition is common in cancer patients, which is one of the
significant factors affecting the overall survival, toxicity during anticancer treatment,
and quality of life among patients with cancer. Previous studies have shown that the
increased protein intake can stimulate muscle synthesis, and improve muscle mass,
strength, function, overall survival, and quality of life. The current study is going to
investigate the effectiveness and safety of protein supplements on patients with cancer,
in order to provide a reference for further nutrition treatment.
Detailed description:
An anticipated total of 100 participants will randomly assigned to receive either a
20-gram protein supplement per day or nutrition counseling to increase the protein
intake. there will be a total of 3 study visits, and dietary assessment and blood sample
collection will occur at every study visit. Intention-to-treat analysis (ITT) and
per-protocol analysis (PP) will be used in statistical analysis.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- • Age>=18years old;
- Initial treatment patients with lung/gastrointestinal/esophageal cancer
- Patients with nutritional risk (NRS-2002≥3) ;
- Patients are able to provide written informed consent.
Exclusion Criteria:
- • People who are allergic to whey protein.
- Participants received any drugs or supplements known to influence the outcomes,
such as protein powder, anabolic steroids, or glucocorticoids before the 3
months preceding the study.
- Participants with gastrointestinal bleeding or intestinal obstruction, or any
contraindication for oral intake
- Concurrent severe cardiac disease, liver and renal failure, which may
significantly interfere with study compliance.
- Participants with electronic or mental device.
- Women in pregnancy or lactation period
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
April 2023
Completion date:
December 2024
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05802381
