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NCT Number: NCT02949076

Skeletal Muscle Atrophy and Dysfunction in Human Cancer

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

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Key information

Conditions

Nonsmall Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Vermont College of Medicine

Burlington, Vermont, 05405, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 50-75 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Cross-sectional area of skeletal muscle fibers

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

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

  2. Single muscle fiber contractile function

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

    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

  3. Mitochondrial content

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

    Mitochondrial content will be assessed by electron microscopy.

  4. Mitochondrial function

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

    Mitochondrial function will be assessed on isolated mitochondria

Secondary outcomes

  1. Whole muscle size

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

    Whole muscle size will be measured by computed tomography at the mid-thigh level.

  2. Whole muscle isometric function

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

    Whole muscle volitional contractile function will be measured by isometric Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks by isometric dynamometry.

  3. Whole muscle isokinetic function

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

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

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Collaborators

  • University of South Carolina

Registry information

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Oct 31, 2016
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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