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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer; Malnutrition
• Intervention / Treatment: Dietary supplement: protein supplement; Behavioral: nutrition counseling

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kang Yu, MD; Phone Number: +8613801130457; Email: yuk1997@sina.com
• Study Contact Backup: Name: Fang Wang, MD; Phone Number: +8615201646084; Email: yours.fang@Hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: protein supplements; This group will receive dietary guidance and protein supplements for 3 months	Dietary supplement: protein supplement; 20 gram protein supplement per day; Other Names: protein; Behavioral: nutrition counseling; nutrition counseling for guidance of food intake
Other: dietary guidance; this group will receive dietary guidance for 3 months	Behavioral: nutrition counseling; nutrition counseling for guidance of food intake

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Director: Kang Yu, MD, Peking Union Medical College Hospital; Principal Investigator: Fang Wang, MD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: March 27, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: cancer; malnutrition; protein; nutritional risk
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: protein-malnutrition-cancer

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No