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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria - Groups 1 Cancer Cachexia & 2 Cancer NO Cachexia:

  • Adults 21 years or older.
  • BMI < 45.
  • Diagnosis of metastatic cancer or localized tumors with cachexia (≥ 5% drop in body mass in less than 12 months), metastatic cancer or localized tumors 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/dlmen, > 1.3mg/dl women).
  • Oral warfarin group medications or history of blood clotting disorders.
  • People who have taken Bevacizumab less than 30 days prior to study muscle biopsy, and scheduled to have another dose of Bevacizumab within 30 days of the muscle biopsy.
  • Platelet count <100,000 per uL within the last 7 days.
  • Pregnancy or breastfeeding.
  • Alcohol consumption greater than 2 glasses/day or other substance abuse.
  • Untreated or uncontrolled thyroid disorders (TSH range of 0.5 to 10 mlU/L).
  • 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 (DXA T Score <-3).
  • The presence of infections, highly communicable diseases (AIDS, active tuberculosis, venereal 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.

Inclusion Criteria - Group 3 NO Cancer:

  • Adults 21 years or older.
  • BMI < 45.

Exclusion Criteria:

  • Diagnosis of Rheumatoid Arthritis.
  • Current use of corticosteroids.
  • Diagnosis of COPD: Chronic Obstructive Pulmonary Disease.
  • Patient is taking calcium or vitamin D supplements and unwilling to stop for study duration.
  • Calcium or phosphorus level above the institutional upper limit of normal.
  • Fasting plasma glucose ≥ 126 mg/dL.
  • Renal failure (serum creatinine > 1.5mg/dl men, > 1.3mg/dl women).
  • Chronic active liver disease (Total Bilirubin > 1.2mg/dl, AST> 1.5IU/L, or ALT>1.5IU/L).
  • History of chronic hepatitis.
  • 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).
  • Oral warfarin group medications or history of blood clotting disorders.
  • People who have taken Bevacizumab in the last 6 weeks.
  • Platelet count <100,000 per uL within the last 7 days.
  • Pregnancy or breastfeeding.
  • Alcohol consumption greater than 2 glasses/day or other substance abuse.
  • Untreated or uncontrolled thyroid disorders (TSH > 10 or <. 5mlU/L).
  • 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 ( DXA T Score < - 3).
  • The presence of infections, highly communicable diseases (AIDS, active tuberculosis, venereal 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.

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Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Rajiv Kumar, M.D.

Closed for enrollment

Contact information:

Christine Huyber

(507) 266-0984

Huyber.Christine@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20265562

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