NCT05802381

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer
• Malnutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	protein supplement	20 gram protein supplement per day
BEHAVIORAL	nutrition counseling	nutrition counseling for guidance of food intake

Timeline

• Start date: 2023-04-01
• Primary completion: 2024-04-01
• Completion: 2024-12-01
• First posted: 2023-04-06
• Last updated: 2023-04-06