Body Composition and White Adipose Tissue Inflammation

Completed

• Conditions: Body Composition; White Adipose Tissue Inflammation; Breast Cancer; Prostate Cancer
• Interventions: Device: DEXA Scan; Behavioral: Godin Leisure Time Exercise Questionnaire (GLTEQ)

• Registration Number: NCT02713022
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-04
• Study First Submitted: 2016-03-11
• Study First Submitted QC: 2016-03-15
• Study First Posted: 2016-03-18
• Status Verified: 2023-11
• Primary Completion: 2023-11-07
• Study Completion: 2023-11-07
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prostate Cancer	Godin Leisure Time Exercise Questionnaire (GLTEQ)	DEXA scan will be carried out 1 to 30 days prior to radical prostatectomy. Patients will also complete the Godin Leisure Time Exercise Questionnaire (GLTEQ) and their waist to hip ratio will be measured.
Breast Cancer	DEXA Scan	DEXA scan will be carried out 1 to 30 days prior to mastectomy. Patients will also complete the Godin Leisure Time Exercise Questionnaire (GLTEQ) and their waist to hip ratio will be measured.
Breast Cancer	Godin Leisure Time Exercise Questionnaire (GLTEQ)	DEXA scan will be carried out 1 to 30 days prior to mastectomy. Patients will also complete the Godin Leisure Time Exercise Questionnaire (GLTEQ) and their waist to hip ratio will be measured.
Prostate Cancer	DEXA Scan	DEXA scan will be carried out 1 to 30 days prior to radical prostatectomy. Patients will also complete the Godin Leisure Time Exercise Questionnaire (GLTEQ) and their waist to hip ratio will be measured.

Primary Outcome Measures

Name	Time	Method
fat percentage	1 year	as measured by DEXA
presence of White Adipose Tissue Inflammation (WATi )	1 year	as measured by DEXA

Trial Locations

Locations (9)

Memorial Sloan Kettering Cancer Center @ Commack (Consent Only); 🇺🇸 Commack, New York, United States

Waters Corporation (Data Analysis Only); 🇺🇸 Milford, Massachusetts, United States

Memorial Sloan Kettering Westchester (Consent Only); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Monmouth (Consent Only); 🇺🇸 Middletown, New Jersey, 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, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Cancer Center (Consent Only); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Bergen (Consent only); 🇺🇸 Montvale, New Jersey, United States