Cancer-Associated Muscle Atrophy and Weakness: An Investigation of Etiology
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
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| No cancer Men and women (ages 35-80 years) without cancer, but similar age and sex as groups with cancer. |
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 35-80 years
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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:
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Current use of vitamin D analogs
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Fasting plasma glucose ≥126 mg/dL
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Renal failure (serum creatinine > 1.5mg/dl)
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Chronic active liver disease (Bilirubin > 17mmol/L, AST>144IU/L, or ALT>165IU/L)
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Contraindications to MRI (e.g., pacemaker, ferrous materials within body).
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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)
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Renal insufficiency/failure (serum creatinine > 1.5mg/dl)
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Oral warfarin group medications or history of blood clotting disorders.
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People who have taken Bevacizumab
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Platelet count <100,000 per uL
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Pregnancy or breastfeeding
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Alcohol consumption greater than 2 glasses/day or other substance abuse
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Untreated or uncontrolled thyroid disorders
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Debilitating chronic disease (at the discretion of the investigators)
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Previous injury/trauma/surgery to the region being measured without full recovery
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Pain in the area to be assessed
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Any medical condition affecting the ability to execute a maximal muscle contraction
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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.
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Significant neurological or musculoskeletal disorders or disease that may interfere with safely executing maximal contraction
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Any congenital, developmental, or other bone disease or previous surgeries that may interfere with successful testing
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Rajiv Kumar, MD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 16-007030