Maladaptive Adipose Tissue Activity in Cancer

Terminated

• Conditions: Cancer Nos
• Interventions: Procedure: Resting Energy Expenditure; Other: Thermal Comfort Questionnaire

• Registration Number: NCT03621124
• Lead Sponsor: Virginia Commonwealth University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-08-01
• Study First Submitted QC: 2018-08-06
• Study First Posted: 2018-08-08
• Study Start: 2018-08-16
• Primary Completion: 2020-05-20
• Study Completion: 2020-05-20
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-23
• Last Update Posted: 2022-04-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Brown Adipose Tissue Positive patients	Resting Energy Expenditure	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.
Brown Adipose Tissue Negative Patients	Resting Energy Expenditure	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.
Brown Adipose Tissue Positive patients	Thermal Comfort Questionnaire	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.
Brown Adipose Tissue Negative Patients	Thermal Comfort Questionnaire	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.

Primary Outcome Measures

Name	Time	Method
Difference in resting energy expenditure between brown adipose tissue (BAT)-positive and BAT-negative patients with cancer.	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.

Secondary Outcome Measures

Name	Time	Method
Difference in energy expenditure between room temperature and response to warm exposure (energy expenditure) in BAT-positive and BAT-negative cancer patients.	27 Months	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.

Trial Locations

Locations (1)

Virginia Commonwealth University/ Massey Cancer Center; 🇺🇸 Richmond, Virginia, United States