Effects of Protein on Muscle, Gut Microbiota and Clinical Outcome in Patients With Lung Cancer-related Sarcopenia

Not Applicable

Not yet recruiting

• Conditions: Lung Cancer; Sarcopenia
• Interventions: Dietary Supplement: soy protein; Dietary Supplement: whey protein; Dietary Supplement: placebo

• Registration Number: NCT05771207
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2023-02-23
• Status Verified: 2023-03
• Study Start: 2023-03
• Study First Submitted QC: 2023-03-05
• Last Update Submitted: 2023-03-05
• Study First Posted: 2023-03-16
• Last Update Posted: 2023-03-16
• Primary Completion: 2023-10
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
soy protein intervention	soy protein	This group received dietary guidance and soy protein intervention for 3 months
whey protein intervention	whey protein	This group received dietary guidance and whey protein intervention for 3 months
control	placebo	This group received dietary guidance and ｍltodextrin for 3 months

Primary Outcome Measures

Name	Time	Method
Change from Baseline Appendicular skeletal muscle mass index at 3 months	3 months	Defined as muscle mass (Unit: kg/m2)

Secondary Outcome Measures

Name	Time	Method
Incidence of Chemotherapy toxicity	3 months	Measured after initiation of chemotherapy using the WHO Toxicity Grades (gradeI-IV) with higher grades neaning severer chemotheraphy toxicity.
Change from Baseline physical performance Baseline at 3 months	3 months	Measured by Short Physical Performance Battery (0-12) with higher scores meaning better physical performance.
Change from Baseline Hand grip at 3 months	3 months	Defined as muscle strength (Unit: kg)
Change from Baseline Physical function at 3 months	3 months	Measured by FRAIL scale (0-5) with higher scores meaning better physical function.
Number of patients with good Chemotherapy Tolerance	3 months	Completing initially planned chemotherapy course is defined as good tolerance; dose adjustment, delayed completion or interruption of treatment are considered as poor tolerance.
Change from Baseline Quality of life questionnaire at 3 months	3 months	Measured by EuroQol- 5 Dimension scale (0-5) with higher scores meaning better Quality of life.
Change from Baseline gut microbiota composition at 3 months	3 months	The stool samples of participants before and after intervention were collected and analized by 16S rRNA.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China