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Skeletal Muscle Atrophy and Dysfunction in Human Cancer

Primary Purpose

Nonsmall Cell Lung Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Nonsmall Cell Lung Cancer

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Vermont College of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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
Mitochondrial content
Mitochondrial content will be assessed by electron microscopy.
Mitochondrial function
Mitochondrial function will be assessed on isolated mitochondria

Secondary Outcome Measures

Whole muscle size
Whole muscle size will be measured by computed tomography at the mid-thigh level.
Whole muscle isometric function
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
Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks by isokinetic dynamometry

Full Information

First Posted
October 25, 2016
Last Updated
October 31, 2022
Sponsor
University of Vermont
Collaborators
University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT02949076
Brief Title
Skeletal Muscle Atrophy and Dysfunction in Human Cancer
Official Title
Skeletal Muscle Atrophy and Dysfunction in Human Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 2016 (undefined)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
Collaborators
University of South Carolina

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonsmall Cell Lung Cancer

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
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 Measure Information:
Title
Cross-sectional area of skeletal muscle fibers
Description
Cross-sectional area of skeletal muscle fibers will be evaluated using immunohistochemistry, with specification of all relevant muscle fiber types
Time Frame
Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
Title
Single muscle fiber contractile function
Description
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
Time Frame
Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
Title
Mitochondrial content
Description
Mitochondrial content will be assessed by electron microscopy.
Time Frame
Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
Title
Mitochondrial function
Description
Mitochondrial function will be assessed on isolated mitochondria
Time Frame
Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
Secondary Outcome Measure Information:
Title
Whole muscle size
Description
Whole muscle size will be measured by computed tomography at the mid-thigh level.
Time Frame
Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
Title
Whole muscle isometric function
Description
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.
Time Frame
Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
Title
Whole muscle isokinetic function
Description
Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks by isokinetic dynamometry
Time Frame
Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra Albertson
Phone
802-656-2178
Email
alexandra.albertson@med.uvm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J. Toth, Ph.D.
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Vermont College of Medicine
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandraw Albertson
Phone
802-656-2178
Email
alexandra.albertson@med.uvm.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Skeletal Muscle Atrophy and Dysfunction in Human Cancer

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