Metastatic CancerNCT03012139
Cancer-Associated Muscle Atrophy and Weakness: An Investigation of Etiology
An observational study of Metastatic Cancer and Cachexia; Cancer, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 35 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Metastatic Cancer, Cachexia; Cancer
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to 11 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Neoplasm Metastasis, Cachexia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal muscle oxidative capacity
Muscle oxidative capacity will be measured by magnetic resonance spectroscopy
Measured: 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.
Measured: Approximately within a month of recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startJan 2017
- Primary completion11 Oct 2019
- Study completion11 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajiv Kumar, M.D., Mayo Clinic
- Investigators
- Rajiv Kumar, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012139
- Sponsor's protocol ID
- 16-007030
- Status last verified
- Jan 2020
- First submitted
- 3 Jan 2017
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer-Associated Muscle Atrophy and Weakness: An Investigation of Etiology
- ClinicalTrials.gov ID
- NCT03012139
- Acronym / sponsor ID
- 16-007030
- Conditions
- Metastatic Cancer, Cachexia; Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- 11 Oct 2019 (actual)
- Study completion
- 11 Oct 2019 (actual)
- First posted
- 6 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (20 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Skeletal muscle oxidative capacity
Time frame: Approximately within a month of recruitment
Muscle oxidative capacity will be measured by magnetic resonance spectroscopy
Skeletal muscle protein synthesis
Time frame: Approximately within a month of recruitment
Muscle protein synthesis will be measured in the postabsorptive state from the rate of incorporation of isotopically labeled amino acids given intravenously.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajiv Kumar, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Cancer and Cachexia; Cancer, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal muscle oxidative capacity (time frame: Approximately within a month of recruitment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2020.