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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| protein supplements | Experimental | This group will receive dietary guidance and protein supplements for 3 months |
|
| dietary guidance | Other | this group will receive dietary guidance for 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| protein supplement | Dietary Supplement | 20 gram protein supplement per day |
|
| 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 |
| 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 |
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Inclusion Criteria:
• Age>=18years old;
Exclusion Criteria:
• People who are allergic to whey protein.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kang Yu, MD | Contact | +8613801130457 | yuk1997@sina.com | |
| Fang Wang, MD | Contact | +8615201646084 | yours.fang@Hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Kang Yu, MD | Peking Union Medical College Hospital | Study Director |
| Fang Wang, MD | Peking Union Medical College Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D011506 | Proteins |
| ID | Term |
|---|---|
| D000602 | Amino Acids, Peptides, and Proteins |
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| nutrition counseling | Behavioral | nutrition counseling for guidance of food intake |
|
| 6 month |
| dose limitation | dose limitation | 6 months |