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

NCT ID: NCT03012139

Last Updated: 2020-01-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 31 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2019-10-11

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.

Conditions

Metastatic Cancer; Cachexia; Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Cancer with cachexia

Men and women (ages 35-80 years) with cancer cachexia (≥5% drop in body mass in less than 12 months)

No interventions assigned to this group

Cancer without cachexia

Men and women (ages 35-80 years) with cancer but without cachexia of similar age and sex as the group with cachexia

No interventions assigned to this group

No cancer

Men and women (ages 35-80 years) without cancer, but similar age and sex as groups with cancer.

No interventions assigned to this group

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Rajiv Kumar, M.D.

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rajiv Kumar, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

16-007030

Identifier Type: -

Identifier Source: org_study_id