Maladaptive Adipose Tissue Activity in Cancer

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.

Study Overview

• Status: Terminated
• Conditions: Cancer Nos
• Intervention / Treatment: Procedure: Resting Energy Expenditure; Other: Thermal Comfort Questionnaire

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 Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298-0070
      • Virginia Commonwealth University/ Massey Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.; Other Names: ENRGEXP; Other: Thermal Comfort Questionnaire; 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; 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; 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.; Other Names: ENRGEXP; Other: Thermal Comfort Questionnaire; Patients will be given a questionnaire to assess their thermal response (whether they felt warmer or colder) during each study visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	27 Months

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2018
• Primary Completion (Actual): May 20, 2020
• Study Completion (Actual): May 20, 2020

Study Registration Dates

• First Submitted: August 1, 2018
• First Submitted That Met QC Criteria: August 6, 2018
• First Posted (Actual): August 8, 2018

Study Record Updates

• Last Update Posted (Actual): April 4, 2022
• Last Update Submitted That Met QC Criteria: March 23, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: MCC-17-13470; P30CA016059 (U.S. NIH Grant/Contract); NCI-2018-01510 (Other Identifier: NCI CTRP); HM20009089 (Other Identifier: IRB No.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No