Maladaptive Adipose Tissue Activity in Cancer

Cancer Nos Clinical Trial

Official title:

Maladaptive Adipose Tissue Activity in Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03621124
• Other study ID #: MCC-17-13470
• Secondary ID: NCI-2018-01510P3
• Status: Terminated
• Start date: August 16, 2018
• Est. completion date: May 20, 2020

Study information

• Verified date: March 2022
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: May 20, 2020
• Est. primary completion date: May 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Nos
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Virginia Commonwealth University/ Massey Cancer Center	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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