Impact of Body Mass Index on Outcomes of Breast Cancer Management

NCT ID: NCT03429504

Last Updated: 2018-02-12

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

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-12

Study Completion Date

2019-08-12

Brief Summary

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Obesity has been linked to an increased risk of developing a number of malignancies, including postmenopausal breast cancer. One of the established risk factors for breast cancer development in post-menopausal women is obesity which has further been linked to breast cancer recurrence and poorer survival in pre- and post-menopausal breast cancer.

Detailed Description

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The biological mechanisms underlying the association between obesity and breast cancer could involve interacting mediators of hormones, adipocytokines, and inflammatory cytokines which link to cell survival or apoptosis, migration and proliferation. Higher level of oestradiol produced in postmenopausal women through aromatization of androgens in the adipose tissues and higher level of insulin, a condition common in obese women, are linked to poorer prognosis in breast cancer. A possible interaction between leptin, insulin and obesity-related markers of inflammation have also been linked to breast cancer outcomes. Non-biological mechanisms could include chemotherapy under-dosing in obese women, suboptimal treatment, and obesity-related complications.

The impact of body mass index on treatment outcome in patients receiving endocrine therapy, there have been consistent results indicating that the efficacy of aromatase inhibitors vary with body mass index; however, the efficacy of tamoxifen is not body mass index-dependent. In the Arimidex, Tamoxifen, Alone or in Combination trial, which compared the efficacy of anastrozole against tamoxifen as an adjuvant treatment for hormone receptor-positive post-menopausal breast cancer patients, anastrozole, a non-steroidal aromatase inhibitor, was significantly less effective in post-menopausal breast cancer patients with a high body mass index, whereas an equal efficacy of tamoxifen was shown across all body mass index levels.

Observational study. Retrospective analysis of data that will be collected from breast cancer patients medical records as body mass index and their response to treatment, progression free survival and overall survival.

Conditions

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Obesity and Breast Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Obese breast cancer patients

Response to treatment and progression free survival in obese breast cancer patients

No interventions assigned to this group

non obese breast cancer patients

Response to treatment and progression free survival in non obese breast cancer patients

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Medical records of female Patients with breast cancer at clinical oncology and nuclear medicine department, Assiut University Hospital between (1st Jan 2012 and 31st Dec 2016), their recorded body mass index and their follow up will be included in the study.

Exclusion Criteria

* Patients' medical records that had no documented weight and height.
* Patients' medical records that had no documented follow up.
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Moheb Ibrahim Melek

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aiat M Mohamed, MD

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

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Samir S Mohamed, MD

Role: CONTACT

00201222302375

Abeer F Amin, MD

Role: CONTACT

00201017483475

References

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Deglise C, Bouchardy C, Burri M, Usel M, Neyroud-Caspar I, Vlastos G, Chappuis PO, Ceschi M, Ess S, Castiglione M, Rapiti E, Verkooijen HM. Impact of obesity on diagnosis and treatment of breast cancer. Breast Cancer Res Treat. 2010 Feb;120(1):185-93. doi: 10.1007/s10549-009-0459-1. Epub 2009 Jul 14.

Reference Type BACKGROUND
PMID: 19597985 (View on PubMed)

Yung RL, Ligibel JA. Obesity and breast cancer: risk, outcomes, and future considerations. Clin Adv Hematol Oncol. 2016 Oct;14(10):790-797.

Reference Type BACKGROUND
PMID: 27930630 (View on PubMed)

Protani M, Coory M, Martin JH. Effect of obesity on survival of women with breast cancer: systematic review and meta-analysis. Breast Cancer Res Treat. 2010 Oct;123(3):627-35. doi: 10.1007/s10549-010-0990-0. Epub 2010 Jun 23.

Reference Type BACKGROUND
PMID: 20571870 (View on PubMed)

Ligibel J. Obesity and breast cancer. Oncology (Williston Park). 2011 Oct;25(11):994-1000.

Reference Type BACKGROUND
PMID: 22106549 (View on PubMed)

Niraula S, Ocana A, Ennis M, Goodwin PJ. Body size and breast cancer prognosis in relation to hormone receptor and menopausal status: a meta-analysis. Breast Cancer Res Treat. 2012 Jul;134(2):769-81. doi: 10.1007/s10549-012-2073-x. Epub 2012 May 5.

Reference Type BACKGROUND
PMID: 22562122 (View on PubMed)

Sestak I, Distler W, Forbes JF, Dowsett M, Howell A, Cuzick J. Effect of body mass index on recurrences in tamoxifen and anastrozole treated women: an exploratory analysis from the ATAC trial. J Clin Oncol. 2010 Jul 20;28(21):3411-5. doi: 10.1200/JCO.2009.27.2021. Epub 2010 Jun 14.

Reference Type BACKGROUND
PMID: 20547990 (View on PubMed)

Other Identifiers

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BMIBC

Identifier Type: -

Identifier Source: org_study_id

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