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OpenTrials
Completed

NCT Number: NCT03012139

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.

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Key information

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Skeletal muscle oxidative capacity

    Time frame: Approximately within a month of recruitment

    Muscle oxidative capacity will be measured by magnetic resonance spectroscopy

  2. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 6, 2017
Registry last updated
Jan 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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