Skeletal Muscle Atrophy and Dysfunction in Human Cancer

NCT ID: NCT02949076

Last Updated: 2023-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2023-06-30

Brief Summary

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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

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Conditions

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Nonsmall Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of South Carolina

OTHER

Sponsor Role collaborator

University of Vermont

OTHER

Sponsor Role lead

Responsible Party

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Michael J. Toth, Ph.D.

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael J. Toth, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Locations

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University of Vermont College of Medicine

Burlington, Vermont, United States

Site Status

Countries

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United States

Other Identifiers

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16-506

Identifier Type: -

Identifier Source: org_study_id