Cancer NosNCT03621124
Maladaptive Adipose Tissue Activity in Cancer
An observational study of Cancer Nos, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of this pilot research is to study brown adipose tissue, a type of fat that increases metabolism (burns energy) during exposure to cold, and how it may contribute to the weight loss observed in cancer. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cancer Nos
- What is being tested?
- Resting Energy Expenditure and Thermal Comfort Questionnaire
- Type of treatment
- Surgery or procedure
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2018to 20 May 2020
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients equal to or greater than forty years of age with an active cancer diagnosis.
Who may be able to join
- ≥ 40 years of age
- Have active cancer diagnosis.
- Have had a PET/CT scan within the past 12 months at time of enrollment.
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Current use of beta-blockers
- Women who are pregnant or unsure of their pregnancy status
- Women who are breastfeeding
- Suffers from severe claustrophobia
- Diagnosed with a serious psychiatric condition which could impede the judgement of the investigators, and/or the successful conduct of the recording.
- In remission stage for cancer diagnosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University/ Massey Cancer Center
Richmond, Virginia, 23298-0070
About this study
The purpose of this pilot research is to study brown adipose tissue, a type of fat that increases metabolism (burns energy) during exposure to cold, and how it may contribute to the weight loss observed in cancer.
Read the detailed description
The purpose of this research is to study brown adipose tissue, a type of fat that increases metabolism (burns energy) during exposure to cold, and how it may contribute to the weight loss observed in cancer. Many patients affected by cancer lose weight, despite normal or increased nutrition. It may progress to the condition called "cancer-associated cachexia." Cancer associated cachexia is defined by an ongoing loss of skeletal muscle mass with or without the loss of fat mass, and may negatively affect quality of life and the ability to undergo cancer treatments. Metabolism is the breakdown of food by the body into the energy that your body needs.
- Conditions
- Cancer Nos
- Being tested
- Resting Energy Expenditure, Thermal Comfort Questionnaire
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resting Energy ExpenditureProcedure or surgery
Also called ENRGEXP
During each visit, the participant will be assessed in a resting state in a stable temperature controlled environment, and will undergo tests to find out how the body adjusts its metabolism to different temperatures.
Thermal Comfort QuestionnaireOther
Patients will be given a questionnaire to assess their thermal response (whether they felt warmer or colder) during each study visit.
| Study group | Role | What they receive |
|---|---|---|
| Brown Adipose Tissue Positive patients | Patients with known malignancy and incidental finding of positron emission tomography/ computerized tomography (PET/CT) scans positive for brown adipose tissue (BAT). After obtaining informed consent and all initial screening visit procedures, patients will participate in two four-hour recording sessions in the whole room indirect calorimeter to assess resting energy expenditure, and patient's thermal (comfort) response to the temperature of the room. Receives: Procedure: Resting Energy Expenditure; Other: Thermal Comfort Questionnaire | |
| Brown Adipose Tissue Negative Patients | Patients with known malignancy and no evidence of brown adipose tissue BAT activity positron emission tomography/ computerized tomography (PET/CT) scans to be matched to group 1 for primary tumor and stage, sex, age (±5 years), BMI (±3 Kg/m2). After obtaining informed consent and all initial screening visit procedures, patients will participate in two four-hour recording sessions in the whole room indirect calorimeter to assess resting energy expenditure, and patient's thermal (comfort) response to the temperature of the room. Receives: Procedure: Resting Energy Expenditure; Other: Thermal Comfort Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in resting energy expenditure between brown adipose tissue (BAT)-positive and BAT-negative patients with cancer.
Characterization of the energy metabolism profiles of cancer patients with and without evidence of BAT activation will be assessed utilizing one sided t-test.
Measured: 27 Months
Secondary outcomes (1)
Difference in energy expenditure between room temperature and response to warm exposure (energy expenditure) in BAT-positive and BAT-negative cancer patients.
Assessment of environmental modulation as an effective strategy to mitigate maladaptive BAT activation in patients with malignancy will be assessed by two-sided t-test.
Measured: 27 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start16 Aug 2018
- Primary completion20 May 2020
- Study completion20 May 2020
Why it stopped: COVID-19 Pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer NosStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Francesco S Celi, MD, MHSc, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621124
- Sponsor's protocol ID
- MCC-17-13470
- Other IDs
- NCI-2018-01510, P30CA016059, HM20009089
- Status last verified
- Apr 2026
- First submitted
- 1 Aug 2018
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maladaptive Adipose Tissue Activity in Cancer
- ClinicalTrials.gov ID
- NCT03621124
- Acronym / sponsor ID
- MCC-17-13470
- Conditions
- Cancer Nos
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COVID-19 Pandemic
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 20 May 2020 (actual)
- Study completion
- 20 May 2020 (actual)
- First posted
- 8 Aug 2018 (actual)
- 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.
The purpose of this pilot research is to study brown adipose tissue, a type of fat that increases metabolism (burns energy) during exposure to cold, and how it may contribute to the weight loss observed in cancer.
Detailed description
The purpose of this research is to study brown adipose tissue, a type of fat that increases metabolism (burns energy) during exposure to cold, and how it may contribute to the weight loss observed in cancer. Many patients affected by cancer lose weight, despite normal or increased nutrition. It may progress to the condition called "cancer-associated cachexia." Cancer associated cachexia is defined by an ongoing loss of skeletal muscle mass with or without the loss of fat mass, and may negatively affect quality of life and the ability to undergo cancer treatments. Metabolism is the breakdown of food by the body into the energy that your body needs.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brown Adipose Tissue Positive patients | – | Procedure: Resting Energy Expenditure, Other: Thermal Comfort QuestionnairePatients with known malignancy and incidental finding of positron emission tomography/ computerized tomography (PET/CT) scans positive for brown adipose tissue (BAT). After obtaining informed consent and all initial screening visit procedures, patients will participate in two four-hour recording sessions in the whole room indirect calorimeter to assess resting energy expenditure, and patient's thermal (comfort) response to the temperature of the room. |
| Brown Adipose Tissue Negative Patients | – | Procedure: Resting Energy Expenditure, Other: Thermal Comfort QuestionnairePatients with known malignancy and no evidence of brown adipose tissue BAT activity positron emission tomography/ computerized tomography (PET/CT) scans to be matched to group 1 for primary tumor and stage, sex, age (±5 years), BMI (±3 Kg/m2). After obtaining informed consent and all initial screening visit procedures, patients will participate in two four-hour recording sessions in the whole room indirect calorimeter to assess resting energy expenditure, and patient's thermal (comfort) response to the temperature of the room. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients equal to or greater than forty years of age with an active cancer diagnosis.
Key inclusion criteria (4 listed)
- ≥ 40 years of age
- Have active cancer diagnosis.
- Have had a PET/CT scan within the past 12 months at time of enrollment.
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (6 listed)
- Current use of beta-blockers
- Women who are pregnant or unsure of their pregnancy status
- Women who are breastfeeding
- Suffers from severe claustrophobia
- Diagnosed with a serious psychiatric condition which could impede the judgement of the investigators, and/or the successful conduct of the recording.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resting Energy ExpenditureAlso: ENRGEXPDuring each visit, the participant will be assessed in a resting state in a stable temperature controlled environment, and will undergo tests to find out how the body adjusts its metabolism to different temperatures. | Procedure or surgery | Brown Adipose Tissue Negative Patients, Brown Adipose Tissue Positive patients |
| Thermal Comfort QuestionnairePatients will be given a questionnaire to assess their thermal response (whether they felt warmer or colder) during each study visit. | Other | Brown Adipose Tissue Negative Patients, Brown Adipose Tissue Positive patients |
Primary outcome
Difference in resting energy expenditure between brown adipose tissue (BAT)-positive and BAT-negative patients with cancer.
Time frame: 27 Months
Characterization of the energy metabolism profiles of cancer patients with and without evidence of BAT activation will be assessed utilizing one sided t-test.
1 secondary outcome
Difference in energy expenditure between room temperature and response to warm exposure (energy expenditure) in BAT-positive and BAT-negative cancer patients.
Time frame: 27 Months
Results and safety
The study was stopped early (reason given: COVID-19 Pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Francesco S Celi, MD, MHSc principal investigator
Virginia Commonwealth University
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 Cancer Nos, run by Virginia Commonwealth University 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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 13 Apr 2026. 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 was stopped early (reason given: COVID-19 Pandemic). Results are not available in the source record.
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?
Difference in resting energy expenditure between brown adipose tissue (BAT)-positive and BAT-negative patients with cancer. (time frame: 27 Months). 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 13 Apr 2026.