Breast CancerNCT02713022
Body Composition and White Adipose Tissue Inflammation
An observational study of Breast Cancer and Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Prostate Cancer, Body Composition
- What is being tested?
- DEXA Scan and Godin Leisure Time Exercise Questionnaire (GLTEQ)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 202 participants
- Where
- 9 sitesUnited States
- Study dates
- 4 Nov 2015to 7 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Memorial Sloan Kettering Cancer Center (Consent Only)
Basking Ridge, New Jersey
Memorial Sloan Kettering Cancer Center @ Commack (Consent Only)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Consent Only)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, 07748
Waters Corporation (Data Analysis Only)
Milford, Massachusetts, 01757
Memorial Sloan Kettering Bergen (Consent only)
Montvale, New Jersey, 07645
Weill Medical College of Cornell University (Data and Specimen Analysis Only)
New York, New York, 10021
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau (Consent only)
Uniondale, New York, 11553
About this study
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.
- Being tested
- DEXA Scan, Godin Leisure Time Exercise Questionnaire (GLTEQ)
- Keywords
- DEXA Scan, 15-235
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEXA ScanDevice
Godin Leisure Time Exercise Questionnaire (GLTEQ)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: DEXA Scan; Behavioral: Godin Leisure Time Exercise Questionnaire (GLTEQ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
fat percentage
as measured by DEXA
Measured: 1 year
presence of White Adipose Tissue Inflammation (WATi )
as measured by DEXA
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study start4 Nov 2015
- Primary completion7 Nov 2023
- Study completion7 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Responsible party
- Sponsor
- Investigators
- Neil Iyengar, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713022
- Sponsor's protocol ID
- 15-235
- Status last verified
- Nov 2023
- First submitted
- 11 Mar 2016
- Last updated
- 8 Nov 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Composition and White Adipose Tissue Inflammation
- ClinicalTrials.gov ID
- NCT02713022
- Acronym / sponsor ID
- 15-235
- Keywords
- DEXA Scan, 15-235
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Study start
- 4 Nov 2015 (actual)
- Primary completion
- 7 Nov 2023 (actual)
- Study completion
- 7 Nov 2023 (actual)
- First posted
- 18 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer | – | Device: DEXA Scan, Behavioral: 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 | – | Device: DEXA Scan, Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEXA Scan | Device | Breast Cancer, Prostate Cancer |
| Godin Leisure Time Exercise Questionnaire (GLTEQ) | Behavioural | Breast Cancer, Prostate Cancer |
Primary outcome
fat percentage
Time frame: 1 year
as measured by DEXA
presence of White Adipose Tissue Inflammation (WATi )
Time frame: 1 year
as measured by DEXA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil Iyengar, MD principal investigator
Memorial Sloan Kettering Cancer Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fat percentage (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.