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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05802381
• Other study ID #: protein-malnutrition-cancer
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2023
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: Peking Union Medical College Hospital
• Contact: Kang Yu, MD
• Phone: +8613801130457
• Email: yuk1997[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Malnutrition

Intervention

Dietary Supplement:
• protein supplement
20 gram protein supplement per day

Behavioral:
• nutrition counseling
nutrition counseling for guidance of food intake

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood toxicity	blood toxicity based on Common Terminology Criteria for Adverse Events (CTCAE)	6 month
Primary	nutritional risk	nutritional risk based on nutrition risk screening-2002 (NRS-2002)	6 months
Primary	malnutrition	malnutrition assessment based on Global Leadership Initiative on Malnutrition (GLIM)	6 months
Secondary	phase angle (PA)	phase angle (PA) assessed by multi-Bioelectric Impedance Analysis (m-BIA)	6 month
Secondary	weight	weight change during the study	6 month
Secondary	dose limitation	dose limitation	6 months