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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Not yet enrolling

Conditions: Malnutrition; Cancer

Treatments: Behavioral: nutrition counseling; Dietary Supplement: protein supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT05802381

protein-malnutrition-cancer

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

protein supplements

Experimental group

Description:

This group will receive dietary guidance and protein supplements for 3 months

Treatment:

Behavioral: nutrition counseling

Dietary Supplement: protein supplement

dietary guidance

Other group

Description:

this group will receive dietary guidance for 3 months

Treatment:

Behavioral: nutrition counseling