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

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Cancer; Cachexia; Cancer

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study will recruit patients with metastatic cancer with or without evidence of cachexia, defined as ≥5% drop in body mass in less than 12 months. Controls without cancer but similar in age, sex, and body mass index will be recruited.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Cancer with cachexia; Men and women (ages 35-80 years) with cancer cachexia (≥5% drop in body mass in less than 12 months)
Cancer without cachexia; Men and women (ages 35-80 years) with cancer but without cachexia of similar age and sex as the group with cachexia
No cancer; Men and women (ages 35-80 years) without cancer, but similar age and sex as groups with cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skeletal muscle oxidative capacity	Muscle oxidative capacity will be measured by magnetic resonance spectroscopy	Approximately within a month of recruitment
Skeletal muscle protein synthesis	Muscle protein synthesis will be measured in the postabsorptive state from the rate of incorporation of isotopically labeled amino acids given intravenously.	Approximately within a month of recruitment

Collaborators and Investigators

• Sponsor: Mayo Clinic

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Actual): October 11, 2019
• Study Completion (Actual): October 11, 2019

Study Registration Dates

• First Submitted: January 3, 2017
• First Submitted That Met QC Criteria: January 4, 2017
• First Posted (Estimate): January 6, 2017

Study Record Updates

• Last Update Posted (Actual): January 21, 2020
• Last Update Submitted That Met QC Criteria: January 16, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Body Weight; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Body Weight Changes; Emaciation; Weight Loss; Muscular Atrophy; Atrophy; Cachexia
• Other Study ID Numbers: 16-007030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No