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

Mayo Clinic

Status: Completed

Conditions: Metastatic Cancer; Cachexia; Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT03012139

16-007030

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 35 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

31 participants in 3 patient groups

Cancer with cachexia

Description:

Men and women (ages 35-80 years) with cancer cachexia (≥5% drop in body mass in less than 12 months)

Cancer without cachexia

Description:

Men and women (ages 35-80 years) with cancer but without cachexia of similar age and sex as the group with cachexia

No cancer

Description:

Men and women (ages 35-80 years) without cancer, but similar age and sex as groups with cancer.