Back to resultsthe Safety and Effectiveness of Protein Supplements on Cancer Patients With Nutritional Risk and Malnutrition
Primary Purpose
Cancer, Malnutrition
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
protein supplement
nutrition counseling
Sponsored by
About this trial
This is an interventional treatment trial for Cancer focused on measuring protein, malnutrition, nutritional risk, cancer
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
protein supplements
dietary guidance
Arm Description
This group will receive dietary guidance and protein supplements for 3 months
this group will receive dietary guidance for 3 months
Outcomes
Primary Outcome Measures
blood toxicity
blood toxicity based on Common Terminology Criteria for Adverse Events (CTCAE)
nutritional risk
nutritional risk based on nutrition risk screening-2002 (NRS-2002)
malnutrition
malnutrition assessment based on Global Leadership Initiative on Malnutrition (GLIM)
Secondary Outcome Measures
phase angle (PA)
phase angle (PA) assessed by multi-Bioelectric Impedance Analysis (m-BIA)
weight
weight change during the study
dose limitation
dose limitation
Full Information
NCT ID
NCT05802381
First Posted
March 27, 2023
Last Updated
March 27, 2023
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05802381
Brief Title
the Safety and Effectiveness of Protein Supplements on Cancer Patients With Nutritional Risk and Malnutrition
Official Title
the Safety and Effectiveness of Protein Supplements on Cancer Patients With Nutritional Risk and Malnutrition
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Malnutrition
Keywords
protein, malnutrition, nutritional risk, cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
protein supplements
Arm Type
Experimental
Arm Description
This group will receive dietary guidance and protein supplements for 3 months
Arm Title
dietary guidance
Arm Type
Other
Arm Description
this group will receive dietary guidance for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
protein supplement
Other Intervention Name(s)
protein
Intervention Description
20 gram protein supplement per day
Intervention Type
Behavioral
Intervention Name(s)
nutrition counseling
Intervention Description
nutrition counseling for guidance of food intake
Primary Outcome Measure Information:
Title
blood toxicity
Description
blood toxicity based on Common Terminology Criteria for Adverse Events (CTCAE)
Time Frame
6 month
Title
nutritional risk
Description
nutritional risk based on nutrition risk screening-2002 (NRS-2002)
Time Frame
6 months
Title
malnutrition
Description
malnutrition assessment based on Global Leadership Initiative on Malnutrition (GLIM)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
phase angle (PA)
Description
phase angle (PA) assessed by multi-Bioelectric Impedance Analysis (m-BIA)
Time Frame
6 month
Title
weight
Description
weight change during the study
Time Frame
6 month
Title
dose limitation
Description
dose limitation
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kang Yu, MD
Phone
+8613801130457
Email
yuk1997@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fang Wang, MD
Phone
+8615201646084
Email
yours.fang@Hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kang Yu, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fang Wang, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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