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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-30

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cancer Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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protein supplements

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

Group Type EXPERIMENTAL

protein supplement

Intervention Type DIETARY_SUPPLEMENT

20 gram protein supplement per day

nutrition counseling

Intervention Type BEHAVIORAL

nutrition counseling for guidance of food intake

dietary guidance

this group will receive dietary guidance for 3 months

Group Type OTHER

nutrition counseling

Intervention Type BEHAVIORAL

nutrition counseling for guidance of food intake

Interventions

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protein supplement

20 gram protein supplement per day

Intervention Type DIETARY_SUPPLEMENT

nutrition counseling

nutrition counseling for guidance of food intake

Intervention Type BEHAVIORAL

Other Intervention Names

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protein

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No