Body Composition and White Adipose Tissue Inflammation

Breast Cancer Clinical Trial

Official title:

Body Composition and White Adipose Tissue Inflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02713022
• Other study ID #: 15-235
• Status: Completed
• Start date: November 4, 2015
• Est. completion date: November 7, 2023

Study information

• Verified date: November 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators want to find a better way to predict the risk of having fatty tissue inflammation by using a different approach to finding out body fat composition. In this study, the investigators want to estimate the body fat composition using a DEXA scan. DEXA stands for dual energy X-ray absorptiometry. It is the standard and established test to determine bone mineral density (how strong the bones are) to diagnose osteoporosis. This test can also be used to determine the body composition including percent body fat and lean mass. The investigators will compare the participants DEXA scan results for body fat composition to the inflammation found in the breast tissue from the mastectomy to see if there is a relationship. If successful, this may help us predict which patients may be at risk for breast cancer in the future. In addition, the investigators will compare the participants DEXA scan results for body fat composition and inflammation found in the fat tissue from the mastectomy or prostatectomy to the level of exercise activity as measured by a short questionnaire to see if there is a relationship. The investigators will also measure the participants waist to hip ratio. Finally, at the time the participant has blood drawn for their standard presurgical testing, the investigators will also test the blood for prediabetes using a blood test called hemoglocin A1c. The investigators will also measure for the participants waist to hip ratio, and a Hgb A1c blood drawn will be take at the time of presurgical testing. If not feasible, Hgb A1c can be drawn at a separate visit prior to the DEXA scan. If successful, this may help us predict which patients may be at risk for breast cancer in the future.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: November 7, 2023
• Est. primary completion date: November 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18
• Female
• All BMIs
• Patients undergoing mastectomy at MSKCC (i.e. Nipple-sparing mastectomy, skin-sparing mastectomy, simple mastectomy, modified radical mastectomy, radical mastectomy); mastectomy may be either prophylactic or therapeutic. OR
• Patients undergoing hysterectomy at MSKCC
• History of prior breast surgeries/procedures is acceptable

Exclusion Criteria:

• Pregnancy (confirmed or suspected);
• Inability to lay supine on equipment table and maintain the position for the necessary time;
• Weight superior to the maximum allowed by the DEXA machine (over 350 lbs or 158 kg);
• Greater than 10% baseline weight loss in the past year;
• Planned surgical procedure is not a Mastectomy (i.e. breast conservation surgery or other non-mastectomy procedure; such as lumpectomy) or hysterectomy
• Metastatic cancer
• History of Wasting Syndromes or Cachexia
• Use of daily NSAIDs, aspirin, or steroids (other than inhaled or topical) within 30 days of surgery
• Use of neoadjuvant systemic or radiation therapy.

Related Conditions & MeSH terms

• Body Composition
• Breast Cancer
• Inflammation
• Prostate Cancer
• White Adipose Tissue Inflammation

Intervention

Device:
• DEXA Scan

Behavioral:
• Godin Leisure Time Exercise Questionnaire (GLTEQ)

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center (Consent Only)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Cancer Center @ Commack (Consent Only)	Commack	New York
United States	Memorial Sloan Kettering Westchester (Consent Only)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (Consent Only)	Middletown	New Jersey
United States	Waters Corporation (Data Analysis Only)	Milford	Massachusetts
United States	Memorial Sloan Kettering Bergen (Consent only)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Weill Medical College of Cornell University (Data and Specimen Analysis Only)	New York	New York
United States	Memorial Sloan Kettering Nassau (Consent only)	Uniondale	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fat percentage	as measured by DEXA	1 year
Primary	presence of White Adipose Tissue Inflammation (WATi )	as measured by DEXA	1 year

External Links

•   Memorial Sloan Kettering Cancer Center