Cancer-Associated Muscle Atrophy and Weakness: An Investigation of Etiology
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-007030
NCT ID: NCT03012139
Sponsor Protocol Number: 16-007030
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.
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Rajiv Kumar, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available