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Maladaptive Adipose Tissue Activity in Cancer

Maladaptive Adipose Tissue Activity in Cancer

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03621124
Enrollment
3
Registered
2018-08-08
Start date
2018-08-16
Completion date
2020-05-20
Last updated
2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Nos

Brief 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.

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.

Interventions

PROCEDUREResting Energy Expenditure

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.

OTHERThermal Comfort Questionnaire

Patients will be given a questionnaire to assess their thermal response (whether they felt warmer or colder) during each study visit.

Sponsors

Virginia Commonwealth University
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* ≥ 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Difference in resting energy expenditure between brown adipose tissue (BAT)-positive and BAT-negative patients with cancer.27 MonthsCharacterization of the energy metabolism profiles of cancer patients with and without evidence of BAT activation will be assessed utilizing one sided t-test.

Secondary

MeasureTime frameDescription
Difference in energy expenditure between room temperature and response to warm exposure (energy expenditure) in BAT-positive and BAT-negative cancer patients.27 MonthsAssessment of environmental modulation as an effective strategy to mitigate maladaptive BAT activation in patients with malignancy will be assessed by two-sided t-test.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORFrancesco S Celi, MD, MHSc

Virginia Commonwealth University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 14, 2026