the Safety and Effectiveness of Protein Supplements on Cancer Patients With Nutritional Risk and Malnutrition

Study Overview
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Brief Summary
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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
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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.

Official Title
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the Safety and Effectiveness of Protein Supplements on Cancer Patients With Nutritional Risk and Malnutrition

Conditions
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Cancer, Malnutrition

Intervention / Treatment
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* Dietary Supplement: protein supplement
* Behavioral: nutrition counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: protein supplements<br>This group will receive dietary guidance and protein supplements for 3 months | Dietary Supplement: protein supplement<br>* 20 gram protein supplement per day<br>* Other names: protein;Behavioral: nutrition counseling<br>* nutrition counseling for guidance of food intake<br>|
| Other: dietary guidance<br>this group will receive dietary guidance for 3 months | Behavioral: nutrition counseling<br>* nutrition counseling for guidance of food intake<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood toxicity | blood toxicity based on Common Terminology Criteria for Adverse Events (CTCAE) | 6 month | 
| nutritional risk | nutritional risk based on nutrition risk screening-2002 (NRS-2002) | 6 months | 
| malnutrition | malnutrition assessment based on Global Leadership Initiative on Malnutrition (GLIM) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| phase angle (PA) | phase angle (PA) assessed by multi-Bioelectric Impedance Analysis (m-BIA) | 6 month | 
| weight | weight change during the study | 6 month | 
| dose limitation | dose limitation | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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protein, malnutrition, nutritional risk, cancer