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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03012139
Other study ID # 16-007030
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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