Cancer-Associated Muscle Atrophy and Weakness: An Investigation of Etiology

Mayo Clinic1 site in 1 country31 target enrollmentJanuary 2017

ConditionsMetastatic Cancer Cachexia; Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Metastatic Cancer
Sponsor: Mayo Clinic
Enrollment: 31
Locations: 1
Primary Endpoint: Skeletal muscle oxidative capacity
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is designed to gain a better understanding of the mechanisms leading to muscle wasting and metabolic abnormalities in skeletal muscle of cancer patients.

Registry

clinicaltrials.gov

Start Date

January 2017

End Date

October 11, 2019

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Mayo Clinic

Responsible Party

Principal Investigator

Rajiv Kumar, M.D.

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

•Age 35-80 years
•Diagnosis of metastatic cancer with cachexia (≥5% drop in body mass in less than 12 months), metastatic cancer without cachexia (\<5% drop in body mass in 12 months) or no history of cancer but similar in age and sex as other groups.

Exclusion Criteria

•Current use of vitamin D analogs
•Fasting plasma glucose ≥126 mg/dL
•Renal failure (serum creatinine \> 1.5mg/dl)
•Chronic active liver disease (Bilirubin \> 17mmol/L, AST\>144IU/L, or ALT\>165IU/L)
•Contraindications to MRI (e.g., pacemaker, ferrous materials within body).
•Active coronary artery disease or history of unstable macrovascular disease (unstable angina, myocardial infarction, stroke, and revascularization of coronary, peripheral or carotid artery within 3 months of recruitment)
•Renal insufficiency/failure (serum creatinine \> 1.5mg/dl)
•Oral warfarin group medications or history of blood clotting disorders.
•People who have taken Bevacizumab
•Platelet count \<100,000 per uL

Outcomes

Primary Outcomes

Skeletal muscle oxidative capacity

Time Frame: Approximately within a month of recruitment

Muscle oxidative capacity will be measured by magnetic resonance spectroscopy

Skeletal muscle protein synthesis

Time Frame: Approximately within a month of recruitment

Muscle protein synthesis will be measured in the postabsorptive state from the rate of incorporation of isotopically labeled amino acids given intravenously.