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Skeletal Muscle Atrophy and Dysfunction in Human Cancer

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ClinicalTrials.gov Identifier: NCT02949076
Recruitment Status : Recruiting
First Posted : October 31, 2016
Last Update Posted : November 4, 2020
Sponsor:
Collaborator:
University of South Carolina
Information provided by (Responsible Party):
Michael J. Toth, Ph.D., University of Vermont

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

Condition or disease Intervention/treatment Phase
Nonsmall Cell Lung Cancer Behavioral: Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Skeletal Muscle Atrophy and Dysfunction in Human Cancer
Study Start Date : July 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise
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
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 Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02949076


Contacts
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Contact: Alexandra Albertson 802-656-2178 alexandra.albertson@med.uvm.edu

Locations
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United States, Vermont
University of Vermont College of Medicine Recruiting
Burlington, Vermont, United States, 05405
Contact: Alexandraw Albertson    802-656-2178    alexandra.albertson@med.uvm.edu   
Sponsors and Collaborators
University of Vermont
University of South Carolina
Investigators
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Principal Investigator: Michael J. Toth, Ph.D. University of Vermont
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Responsible Party: Michael J. Toth, Ph.D., Associate Professor of Medicine, University of Vermont
ClinicalTrials.gov Identifier: NCT02949076    
Other Study ID Numbers: 16-506
First Posted: October 31, 2016    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Research data (deidentified) which documents, supports and validates research findings will be stored on the University of Vermont College of Medicine computer system and will be made available upon final acceptance for publication of the major findings from the proposed studies. This includes raw data generated from all clinical and laboratory-based assessments under a data-sharing agreement.
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Muscular Atrophy
Atrophy
Pathological Conditions, Anatomical
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases