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

Completed

• Conditions: Metastatic Cancer; Cachexia; Cancer

• Registration Number: NCT03012139
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-03
• Study First Submitted QC: 2017-01-04
• Study First Posted: 2017-01-06
• Primary Completion: 2019-10-11
• Study Completion: 2019-10-11
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-16
• Last Update Posted: 2020-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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
• Pregnancy or breastfeeding
• Alcohol consumption greater than 2 glasses/day or other substance abuse
• Untreated or uncontrolled thyroid disorders
• Debilitating chronic disease (at the discretion of the investigators)
• Previous injury/trauma/surgery to the region being measured without full recovery
• Pain in the area to be assessed
• Any medical condition affecting the ability to execute a maximal muscle contraction
• The presence of infections, highly communicable diseases (AIDS, active tuberculosis, veneral disease, hepatitis) or metastatic bone disease that may interfere with safely executing maximal effort.
• Significant neurological or musculoskeletal disorders or disease that may interfere with safely executing maximal contraction
• Any congenital, developmental, or other bone disease or previous surgeries that may interfere with successful testing

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Skeletal muscle oxidative capacity	Approximately within a month of recruitment	Muscle oxidative capacity will be measured by magnetic resonance spectroscopy
Skeletal muscle protein synthesis	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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States