Clinical trial NCT03012139: Cancer-Associated Muscle Atrophy and Weakness: An Investigation of Etiology
Official title: Cancer-Associated Muscle Atrophy and Weakness: An Investigation of Etiology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Cancer
Cachexia; Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-01-06
Enrollment: 31
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will recruit patients with metastatic cancer with or without evidence of cachexia, defined as ≥5% drop in body mass in less than 12 months. Controls without cancer but similar in age, sex, and body mass index will be recruited.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Skeletal muscle oxidative capacity
timeFrame: Approximately within a month of recruitment
measure: Skeletal muscle protein synthesis
timeFrame: Approximately within a month of recruitment
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Rajiv Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References: