Impact of Body Mass Index on Outcomes of Breast Cancer Management

February 6, 2018 updated by: Moheb Ibrahim Melek, Assiut University

Impact of Body Mass Index on Outcomes of Breast Cancer Management (Retrospective Study)

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients with breast cancer that was admitted at clinical oncology and nuclear medicine department, Assiut University Hospital, Egypt

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Obese breast cancer patients
Response to treatment and progression free survival in obese breast cancer patients
non obese breast cancer patients
Response to treatment and progression free survival in non obese breast cancer patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The percentage of obese breast cancer patients with response to treatment compared to non obese breast cancer patients.
Time Frame: The cases will be obtained from the medical records of breast cancer patients admitted to the Clinical Oncology and Nuclear Medicine Department, Assiut University hospital from 1st of January, 2012 - 31st December, 2016
The cases will be obtained from the medical records of breast cancer patients admitted to the Clinical Oncology and Nuclear Medicine Department, Assiut University hospital from 1st of January, 2012 - 31st December, 2016

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Aiat M Mohamed, MD, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 12, 2018

Primary Completion (Anticipated)

February 12, 2019

Study Completion (Anticipated)

August 12, 2019

Study Registration Dates

First Submitted

February 6, 2018

First Submitted That Met QC Criteria

February 6, 2018

First Posted (Actual)

February 12, 2018

Study Record Updates

Last Update Posted (Actual)

February 12, 2018

Last Update Submitted That Met QC Criteria

February 6, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMIBC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity and Breast Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe