Body Composition and White Adipose Tissue Inflammation

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02713022
Collaborator
Weill Medical College of Cornell University (Other)
202
8
83.9
25.3
0.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: DEXA Scan
  • Behavioral: Godin Leisure Time Exercise Questionnaire (GLTEQ)

Study Design

Study Type:
Observational
Actual Enrollment :
202 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Body Composition and White Adipose Tissue Inflammation
Study Start Date :
Nov 4, 2015
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

Device: DEXA Scan

Behavioral: Godin Leisure Time Exercise Questionnaire (GLTEQ)

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.

Device: DEXA Scan

Behavioral: Godin Leisure Time Exercise Questionnaire (GLTEQ)

Outcome Measures

Primary Outcome Measures

  1. fat percentage [1 year]

    as measured by DEXA

  2. presence of White Adipose Tissue Inflammation (WATi ) [1 year]

    as measured by DEXA

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Memoral Sloan Kettering Cancer Center (Consent Only) Basking Ridge New Jersey United States
2 Memorial Sloan Kettering Monmouth (Consent Only) Middletown New Jersey United States 07748
3 Memorial Sloan Kettering Bergen (Consent only) Montvale New Jersey United States 07645
4 Memorial Sloan Kettering Cancer Center @ Commack (Consent Only) Commack New York United States 11725
5 Memorial Sloan Kettering Westchester (Consent Only) Harrison New York United States 10604
6 Memorial Sloan Kettering Cancer Center New York New York United States 10065
7 Memorial Sloan Kettering Nassau (Consent only) Uniondale New York United States 11553
8 Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC) Ile-Ife Nigeria

Sponsors and Collaborators

  • Memorial Sloan Kettering Cancer Center
  • Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Neil Iyengar, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT02713022
Other Study ID Numbers:
  • 15-235
First Posted:
Mar 18, 2016
Last Update Posted:
Apr 26, 2022
Last Verified:
Apr 1, 2022
Keywords provided by Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 26, 2022