the Safety and Effectiveness of Protein Supplements on Cancer Patients With Nutritional Risk and Malnutrition
1 other identifier
interventional
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cancer
Started Apr 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2023
CompletedStudy Start
First participant enrolled
April 1, 2023
CompletedFirst Posted
Study publicly available on registry
April 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedApril 6, 2023
March 1, 2023
1 year
March 27, 2023
March 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (3)
phase angle (PA)
6 month
weight
6 month
dose limitation
6 months
Study Arms (2)
protein supplements
EXPERIMENTALThis group will receive dietary guidance and protein supplements for 3 months
dietary guidance
OTHERthis group will receive dietary guidance for 3 months
Interventions
20 gram protein supplement per day
nutrition counseling for guidance of food intake
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kang Yu, MD
Peking Union Medical College Hospital
- PRINCIPAL INVESTIGATOR
Fang Wang, MD
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2023
First Posted
April 6, 2023
Study Start
April 1, 2023
Primary Completion
April 1, 2024
Study Completion
December 1, 2024
Last Updated
April 6, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share