Body Composition and White Adipose Tissue Inflammation

NCT ID: NCT02713022

Last Updated: 2023-11-08

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

COMPLETED

Total Enrollment

202 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-04

Study Completion Date

2023-11-07

Brief Summary

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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

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Conditions

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Breast Cancer Prostate Cancer Body Composition White Adipose Tissue Inflammation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Breast Cancer

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.

DEXA Scan

Intervention Type DEVICE

Godin Leisure Time Exercise Questionnaire (GLTEQ)

Intervention Type BEHAVIORAL

Prostate Cancer

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.

DEXA Scan

Intervention Type DEVICE

Godin Leisure Time Exercise Questionnaire (GLTEQ)

Intervention Type BEHAVIORAL

Interventions

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DEXA Scan

Intervention Type DEVICE

Godin Leisure Time Exercise Questionnaire (GLTEQ)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neil Iyengar, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Waters Corporation (Data Analysis Only)

Milford, Massachusetts, United States

Site Status

Memorial Sloan Kettering Cancer Center (Consent Only)

Basking Ridge, New Jersey, United States

Site Status

Memorial Sloan Kettering Monmouth (Consent Only)

Middletown, New Jersey, United States

Site Status

Memorial Sloan Kettering Bergen (Consent only)

Montvale, New Jersey, United States

Site Status

Memorial Sloan Kettering Cancer Center @ Commack (Consent Only)

Commack, New York, United States

Site Status

Memorial Sloan Kettering Westchester (Consent Only)

Harrison, New York, United States

Site Status

Weill Medical College of Cornell University (Data and Specimen Analysis Only)

New York, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Memorial Sloan Kettering Nassau (Consent only)

Uniondale, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

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15-235

Identifier Type: -

Identifier Source: org_study_id

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