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

NCT05771207 | Unknown

• 1 other identifier: protein-cancer-sarcopenia2023
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Sarcopenia

Keywords

soy protein; whey protein; lung cancer related sarcopenia

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Appendicular skeletal muscle mass index at 3 months

  Defined as muscle mass (Unit: kg/m2)

  3 months

Secondary Outcomes (7)

• Change from Baseline Hand grip at 3 months

  3 months

• Change from Baseline physical performance Baseline at 3 months

  3 months

• Change from Baseline Physical function at 3 months

  3 months

• Change from Baseline Quality of life questionnaire at 3 months

  3 months

• Change from Baseline gut microbiota composition at 3 months

  3 months

Study Arms (3)

soy protein intervention

EXPERIMENTAL

This group received dietary guidance and soy protein intervention for 3 months

Dietary Supplement: soy protein

whey protein intervention

EXPERIMENTAL

This group received dietary guidance and whey protein intervention for 3 months

Dietary Supplement: whey protein

control

PLACEBO COMPARATOR

This group received dietary guidance and ｍltodextrin for 3 months

Dietary Supplement: placebo

Interventions

soy protein DIETARY_SUPPLEMENT

The intervention is made up of soy protein supplements (30g/d) and dietary pattern modification.

soy protein intervention

whey protein DIETARY_SUPPLEMENT

The intervention is made up of whey protein supplements (30g/d) and dietary pattern modification.

whey protein intervention

placebo DIETARY_SUPPLEMENT

The intervention is made up of maltodextrin (30g/d) and dietary pattern modification.

control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age\>=18years old
• Patients with lung cancer and sarcopenia
• ECOG\<=2
• Patients are able to provide written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Lung Neoplasms; Sarcopenia

Interventions

Soybean Proteins; Whey Proteins

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages; Milk Proteins; Animal Proteins, Dietary; Whey; Milk; Dairy Products

Study Officials

• Kang Yu, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kang Yu, MD

CONTACT

+8613801130457; yuk1997@sina.com

Yu Zang, MD

CONTACT

+8617332739749; zhangyu_a0849@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 16, 2023
• Study Start: March 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: January 1, 2024
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)