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Clinical Trials/NCT02949076
NCT02949076
Completed
Not Applicable

Skeletal Muscle Atrophy and Dysfunction in Human Cancer

University of Vermont1 site in 1 country11 target enrollmentJuly 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nonsmall Cell Lung Cancer
Sponsor
University of Vermont
Enrollment
11
Locations
1
Primary Endpoint
Mitochondrial function
Status
Completed
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
July 2016
End Date
June 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael J. Toth, Ph.D.

Associate Professor of Medicine

University of Vermont

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

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.

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

Secondary Outcomes

  • Whole muscle isokinetic function(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 size(Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks)

Study Sites (1)

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