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

Lung Cancer Clinical Trial

Official title:

Effects of Soy Protein and Whey Protein on Muscle, Gut Microbiota and Clinical Outcome in Patients With Lung Cancer-related Sarcopenia（LCRS）: a Randomized, Double-blind, Controlled Clinical Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05771207
• Other study ID #: protein-cancer-sarcopenia2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2023
• Est. completion date: January 2024

Study information

• Verified date: March 2023
• Source: Peking Union Medical College Hospital
• Contact: Kang Yu, MD
• Phone: +8613801130457
• Email: yuk1997[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: January 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Sarcopenia

Intervention

Dietary Supplement:
• soy protein
The intervention is made up of soy protein supplements (30g/d) and dietary pattern modification.
• whey protein
The intervention is made up of whey protein supplements (30g/d) and dietary pattern modification.
• placebo
The intervention is made up of maltodextrin (30g/d) and dietary pattern modification.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Appendicular skeletal muscle mass index at 3 months	Defined as muscle mass (Unit: kg/m2)	3 months
Secondary	Change from Baseline Hand grip at 3 months	Defined as muscle strength (Unit: kg)	3 months
Secondary	Change from Baseline physical performance Baseline at 3 months	Measured by Short Physical Performance Battery (0-12) with higher scores meaning better physical performance.	3 months
Secondary	Change from Baseline Physical function at 3 months	Measured by FRAIL scale (0-5) with higher scores meaning better physical function.	3 months
Secondary	Change from Baseline Quality of life questionnaire at 3 months	Measured by EuroQol- 5 Dimension scale (0-5) with higher scores meaning better Quality of life.	3 months
Secondary	Change from Baseline gut microbiota composition at 3 months	The stool samples of participants before and after intervention were collected and analized by 16S rRNA.	3 months
Secondary	Number of patients with good Chemotherapy Tolerance	Completing initially planned chemotherapy course is defined as good tolerance; dose adjustment, delayed completion or interruption of treatment are considered as poor tolerance.	3 months
Secondary	Incidence of Chemotherapy toxicity	Measured after initiation of chemotherapy using the WHO Toxicity Grades (gradeI-IV) with higher grades neaning severer chemotheraphy toxicity.	3 months