Skeletal Muscle Atrophy and Dysfunction in Human Cancer

Nonsmall Cell Lung Cancer Clinical Trial

Official title:

Skeletal Muscle Atrophy and Dysfunction in Human Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02949076
• Other study ID #: 16-506
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: June 2023

Study information

• Verified date: November 2023
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Carcinoma, Non-Small-Cell Lung
• Muscular Atrophy
• Nonsmall Cell Lung Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	University of Vermont College of Medicine	Burlington	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
University of Vermont	University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
Primary	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	Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
Primary	Mitochondrial content	Mitochondrial content will be assessed by electron microscopy.	Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
Primary	Mitochondrial function	Mitochondrial function will be assessed on isolated mitochondria	Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
Secondary	Whole muscle size	Whole muscle size will be measured by computed tomography at the mid-thigh level.	Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
Secondary	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.	Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks
Secondary	Whole muscle isokinetic function	Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks by isokinetic dynamometry	Difference between the change in the exercised and non-exercised leg from baseline to 8 weeks