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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer; Sarcopenia
• Intervention / Treatment: Dietary supplement: soy protein; Dietary supplement: whey protein; Dietary supplement: placebo

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kang Yu, MD; Phone Number: +8613801130457; Email: yuk1997@sina.com
• Study Contact Backup: Name: Yu Zang, MD; Phone Number: +8617332739749; Email: zhangyu_a0849@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: soy protein intervention; This group received dietary guidance and soy protein intervention for 3 months	Dietary supplement: soy protein; The intervention is made up of soy protein supplements (30g/d) and dietary pattern modification.
Experimental: whey protein intervention; This group received dietary guidance and whey protein intervention for 3 months	Dietary supplement: whey protein; The intervention is made up of whey protein supplements (30g/d) and dietary pattern modification.
Placebo Comparator: control; This group received dietary guidance and ｍltodextrin for 3 months	Dietary supplement: placebo; The intervention is made up of maltodextrin (30g/d) and dietary pattern modification.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Appendicular skeletal muscle mass index at 3 months	Defined as muscle mass (Unit: kg/m2)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Hand grip at 3 months	Defined as muscle strength (Unit: kg)	3 months
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
Change from Baseline Physical function at 3 months	Measured by FRAIL scale (0-5) with higher scores meaning better physical function.	3 months
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
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
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
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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Kang Yu, MD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: March 5, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 5, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: soy protein; whey protein; lung cancer related sarcopenia
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Neurologic Manifestations; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Lung Neoplasms; Sarcopenia
• Other Study ID Numbers: protein-cancer-sarcopenia2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No