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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

Tracking Information
First Submitted Date  ICMJE October 25, 2016
First Posted Date  ICMJE October 31, 2016
Last Update Posted Date November 4, 2020
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2016)
  • 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
  • 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
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2016)
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Skeletal Muscle Atrophy and Dysfunction in Human Cancer
Official Title  ICMJE Skeletal Muscle Atrophy and Dysfunction in Human Cancer
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Nonsmall Cell Lung Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Behavioral: Exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 26, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alexandra Albertson 802-656-2178 alexandra.albertson@med.uvm.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02949076
Other Study ID Numbers  ICMJE 16-506
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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.
Responsible Party Michael J. Toth, Ph.D., University of Vermont
Study Sponsor  ICMJE University of Vermont
Collaborators  ICMJE University of South Carolina
Investigators  ICMJE
Principal Investigator: Michael J. Toth, Ph.D. University of Vermont
PRS Account University of Vermont
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP