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

Not Applicable

Not yet recruiting

• Conditions: Malnutrition; Cancer
• Interventions: Dietary Supplement: protein supplement; Behavioral: nutrition counseling

• Registration Number: NCT05802381
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-27
• Study First Submitted QC: 2023-03-27
• Last Update Submitted: 2023-03-27
• Study Start: 2023-04
• Study First Posted: 2023-04-06
• Last Update Posted: 2023-04-06
• Primary Completion: 2024-04
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
protein supplements	nutrition counseling	This group will receive dietary guidance and protein supplements for 3 months
protein supplements	protein supplement	This group will receive dietary guidance and protein supplements for 3 months
dietary guidance	nutrition counseling	this group will receive dietary guidance for 3 months

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
phase angle (PA)	6 month	phase angle (PA) assessed by multi-Bioelectric Impedance Analysis (m-BIA)
dose limitation	6 months	dose limitation
weight	6 month	weight change during the study