Skeletal Muscle Atrophy and Dysfunction in Human Cancer

NCT02949076 | Completed DMC

• 1 other identifier: 16-506
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Cancer and its treatment can have profound effects on skeletal muscle, the most well-recognized being atrophy, weakness and diminished oxidative capacity. These adaptations negatively impact quality of life, treatment decisions and survival. Despite these consequences, the factors promoting these adaptations remain poorly defined and understudied in human patients. To address this gap in knowledge, our goal in this study is to examine the role of muscle disuse as a regulator of muscle size and function in human cancer patients

Conditions

Nonsmall Cell Lung Cancer

Outcome Measures

Primary Outcomes (4)

• Cross-sectional area of skeletal muscle fibers

  Cross-sectional area of skeletal muscle fibers will be evaluated using immunohistochemistry, with specification of all relevant muscle fiber types

  Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks

• Single muscle fiber contractile function

  Segments of chemically-skinned single human muscle fibers will be assessed for cellular and molecular contractile parameters under maximal calcium-activated conditions, with muscle fiber type determined post-measurement by gel electrophoresis

  Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks

• Mitochondrial content

  Mitochondrial content will be assessed by electron microscopy.

  Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks

• Mitochondrial function

  Mitochondrial function will be assessed on isolated mitochondria

  Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks

Secondary Outcomes (3)

• Whole muscle size

  Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks

• Whole muscle isometric function

  Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks

• Whole muscle isokinetic function

  Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks

Study Arms (1)

Exercise

EXPERIMENTAL

Lung cancer patients will undergo unilateral resistance exercise 3 times per week for 8 weeks during cancer treatment, while the other leg remains unexercised and will serve as a within-subject control.

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

Unilateral lower limb resistance exercise will be performed 3 times per week for 8 weeks in non-small cell lung cancer patients on only one leg, while the contralateral leg serves as a non-exercising control.

Exercise

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• yrs of age
• histologically-documented, stage III or IV non-small cell lung carcinoma (NSCLC)
• estimated life expectancy \>6 mos
• Karnofsky's performance score of ≥70

You may not qualify if:

• history, signs or symptoms of inflammatory or autoimmune disease
• uncontrolled hypertension
• heart or renal failure
• exercise limitations from peripheral vascular disease or stroke
• neuromuscular disease
• knee/hip replacement
• additional, actively-treated malignancy or history of malignancy, except non-melanoma skin cancer
• taking medication that can have anti-coagulant effects that cannot be stopped prior to the muscle biopsy

Sponsors & Collaborators

• University of Vermont: lead
• University of South Carolina: collaborator

Study Sites (1)

University of Vermont College of Medicine

Burlington, Vermont, 05405, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Exercise

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Michael J. Toth, Ph.D.

  University of Vermont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: October 31, 2016
• Study Start: July 1, 2016
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)