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Trial Title:
Effects of Protein on Muscle, Gut Microbiota and Clinical Outcome in Patients With Lung Cancer-related Sarcopenia
NCT ID:
NCT05771207
Condition:
Lung Cancer
Sarcopenia
Conditions: Official terms:
Lung Neoplasms
Sarcopenia
Conditions: Keywords:
soy protein
whey protein
lung cancer related sarcopenia
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
soy protein
Description:
The intervention is made up of soy protein supplements (30g/d) and dietary pattern
modification.
Arm group label:
soy protein intervention
Intervention type:
Dietary Supplement
Intervention name:
whey protein
Description:
The intervention is made up of whey protein supplements (30g/d) and dietary pattern
modification.
Arm group label:
whey protein intervention
Intervention type:
Dietary Supplement
Intervention name:
placebo
Description:
The intervention is made up of maltodextrin (30g/d) and dietary pattern modification.
Arm group label:
control
Summary:
Sarcopenia is common in lung cancer patients. It is one of the significant factors
affecting the overall survival, radiotherapy and chemotherapy efficacy, and quality of
life of patients with lung cancer. Previous studies have shown that increased protein
intake can stimulate postprandial muscle synthesis, and improve muscle mass, strength,
function, and overall survival. However, most previous studies have focused on the
intervention of whey protein, while the protective effect of soybean protein on lung
cancer-related sarcopenia (LCRS) has not yet been fully explored and reached an
agreement.
So, this study aims to explore the effects of soy and whey protein on muscle, gut
microbiota, and clinical outcomes among patients with lung cancer-related sarcopenia, to
provide a reference for further nutrition treatment.
Detailed description:
This study will last 6 months. For the duration of the study, an anticipated total of 90
participants will be randomly assigned to receive either a 30-gram protein supplement or
a placebo daily. There will be a total of 5 study visits, and dietary records,
questionnaires, blood and stool collection, and functional testing will occur at all
study visits. Intention-to-treat analysis (ITT) and per-protocol analysis (PP) will be
conducted in statistical analysis.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- age>=18years old
- Patients with lung cancer and sarcopenia
- ECOG<=2
- Patients are able to provide written informed consent.
Exclusion Criteria:
- People who are allergic to soy protein and whey protein.
- Participants received any drugs or supplements known to influence effcet size, such
as protein powder, anabolic steroids, or glucorticosteroid before the 3 months
preceding the study.
- Participants with gastrointestinal bleeding, enterotomy or gastric bypass surgery
before the 3 months preceding the study.
- Concurrent severe cardiac disease, liver and renal failure, which may significantly
interfere with study compliance.
- Participants with electronic or mental device.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Start date:
March 2023
Completion date:
January 2024
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05771207
