Maladaptive Adipose Tissue Activity in Cancer

NCT ID: NCT03621124

Last Updated: 2022-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-16

Study Completion Date

2020-05-20

Brief Summary

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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

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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

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Cancer Nos

Study Groups

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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.

Resting Energy Expenditure

Intervention Type 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.

Thermal Comfort Questionnaire

Intervention Type 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

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.

Resting Energy Expenditure

Intervention Type 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.

Thermal Comfort Questionnaire

Intervention Type OTHER

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

Interventions

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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.

Intervention Type PROCEDURE

Thermal Comfort Questionnaire

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

Intervention Type OTHER

Other Intervention Names

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ENRGEXP

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francesco S Celi, MD, MHSc

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virginia Commonwealth University/ Massey Cancer Center

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2018-01510

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA016059

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HM20009089

Identifier Type: OTHER

Identifier Source: secondary_id

MCC-17-13470

Identifier Type: -

Identifier Source: org_study_id

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