Maladaptive Adipose Tissue Activity in Cancer

NCT03621124 | Terminated DMC

• 4 other identifiers: MCC-17-13470NCI-2018-01510P30CA016059HM20009089
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Nos

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  27 Months

Study Arms (2)

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.

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.

Procedure: Resting Energy Expenditure; Other: Thermal Comfort Questionnaire

Interventions

Resting Energy Expenditure PROCEDURE

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.

Also known as: ENRGEXP

Brown Adipose Tissue Negative Patients; Brown Adipose Tissue Positive patients

Thermal Comfort Questionnaire OTHER

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

Brown Adipose Tissue Negative Patients; Brown Adipose Tissue Positive patients

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients equal to or greater than forty years of age with an active cancer diagnosis.

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Virginia Commonwealth University/ Massey Cancer Center

Richmond, Virginia, 23298-0070, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Energy Metabolism

Intervention Hierarchy (Ancestors)

Metabolism

Study Officials

• Francesco S Celi, MD, MHSc

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 8, 2018
• Study Start: August 16, 2018
• Primary Completion: May 20, 2020
• Study Completion: May 20, 2020
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)