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

Metastatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03012139
• Other study ID #: 16-007030
• Status: Completed
• Start date: January 2017
• Est. completion date: October 11, 2019

Study information

• Verified date: January 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 11, 2019
• Est. primary completion date: October 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Cachexia
• Cachexia; Cancer
• Metastatic Cancer
• Muscular Atrophy

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skeletal muscle oxidative capacity	Muscle oxidative capacity will be measured by magnetic resonance spectroscopy	Approximately within a month of recruitment
Primary	Skeletal muscle protein synthesis	Muscle protein synthesis will be measured in the postabsorptive state from the rate of incorporation of isotopically labeled amino acids given intravenously.	Approximately within a month of recruitment