Clinical trial NCT02713022: Body Composition and White Adipose Tissue Inflammation
Official title: Body Composition and White Adipose Tissue Inflammation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Prostate Cancer
Body Composition
White Adipose Tissue Inflammation
Keywords: DEXA Scan
15-235
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
First posted: 2016-03-18
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is open to patients undergoing prophylactic or therapeutic mastectomy or radical prostatectomy at MSKCC.

Patients will be identified and recruited from the Breast Service at and Plastics and Reconstructive Surgery Clinics MSKCC and approached at the time of initial surgical consultation.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: fat percentage
timeFrame: 1 year
measure: presence of White Adipose Tissue Inflammation (WATi )
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Milford
country: United States
facility: Waters Corporation (Data Analysis Only)
state: Massachusetts
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Cancer Center (Consent Only)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent Only)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent only)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Commack (Consent Only)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent Only)
state: New York
city: New York
country: United States
facility: Weill Medical College of Cornell University (Data and Specimen Analysis Only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Consent only)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Neil Iyengar, MD
role: PRINCIPAL_INVESTIGATOR
References: