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Skeletal Muscle Atrophy and Dysfunction in Human Cancer

Skeletal Muscle Atrophy and Dysfunction in Human Cancer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02949076
Enrollment
11
Registered
2016-10-31
Start date
2016-07-31
Completion date
2023-06-30
Last updated
2023-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonsmall Cell Lung 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

Interventions

BEHAVIORALExercise

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.

Sponsors

University of South Carolina
CollaboratorOTHER
University of Vermont
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cross-sectional area of skeletal muscle fibersDifference between the change in the exercised and non-exercised leg from baseline to 8 weeksCross-sectional area of skeletal muscle fibers will be evaluated using immunohistochemistry, with specification of all relevant muscle fiber types
Single muscle fiber contractile functionDifference between the change in the exercised and non-exercised leg from baseline to 8 weeksSegments 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 contentDifference between the change in the exercised and non-exercised leg from baseline to 8 weeksMitochondrial content will be assessed by electron microscopy.
Mitochondrial functionDifference between the change in the exercised and non-exercised leg from baseline to 8 weeksMitochondrial function will be assessed on isolated mitochondria

Secondary

MeasureTime frameDescription
Whole muscle isometric functionDifference between the change in the exercised and non-exercised leg from baseline to 8 weeksWhole 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 functionDifference between the change in the exercised and non-exercised leg from baseline to 8 weeksDifference between the change in the exercised and non-exercised leg from baseline to 8 weeks by isokinetic dynamometry
Whole muscle sizeDifference between the change in the exercised and non-exercised leg from baseline to 8 weeksWhole muscle size will be measured by computed tomography at the mid-thigh level.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026