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

NCT03012139 | Completed

• 1 other identifier: 16-007030
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Skeletal muscle oxidative capacity

  Muscle oxidative capacity will be measured by magnetic resonance spectroscopy

  Approximately within a month of recruitment

• 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

Study Arms (3)

Cancer with cachexia

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

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 cancer

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

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum, and skeletal muscle tissue will be collected.

MeSH Terms

Conditions

Neoplasm Metastasis; Cachexia; Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Thinness

Study Officials

• Rajiv Kumar, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: January 6, 2017
• Study Start: January 1, 2017
• Primary Completion: October 11, 2019
• Study Completion: October 11, 2019
• Last Updated: January 21, 2020

Record last verified: 2020-01

Locations

US (1)