Weight Loss and Breast Cancer

December 8, 2022 updated by: ANIL ERGIN, Fatih Sultan Mehmet Training and Research Hospital

Evaluation of the Relationship Between Weight Loss and Breast Cancer After Laparoscopic Sleeve Gastrectomy Surgery

Obesity is an important risk factor for postmenopausal breast cancer. A large meta-analysis concluded that obesity is associated with a 20% to 40% increased risk for receptor-positive postmenopausal breast cancer. The International Agency for Research on Cancer working group on obesity and cancer risk drew similar conclusions. Obesity seems to have the opposite effect among premenopausal women, with most studies suggesting that higher BMI is associated with a reduced risk of premenopausal breast cancer.

Determining whether deliberate weight loss is associated with a reduced risk of breast cancer is difficult in part because sustained weight loss is difficult to achieve and few studies have sufficient statistical power to address this question. Bariatric surgery is one of the few weight loss interventions in which significant weight loss is maintained. A limited number of previous studies have suggested a reduced risk of cancer following bariatric surgery. Recently, it showed that bariatric surgery is associated with a lower risk of several types of cancer, including an approximately 40 % reduction in the risk of postmenopausal breast cancer. However, whether bariatric surgery affects breast cancer risk in premenopausal women and whether this association is altered by estrogen receptor (ER) status has not been addressed.

The aim of this study is to examine the relationship between weight loss after laparoscopic sleeve gastrectomy (LSG) and breast cancer.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

In this study, 300 female patients who underwent laparoscopic sleeve gastrectomy due to morbid obesity in Fatih Sultan Mehmet Training and Research Hospital General Surgery Clinic will be included. The number of samples was calculated by performing impact power analysis.

Mamagrophy is recommended for all women over the age of 40 as part of the routine cancer screening program in our country. For this reason, it is assumed that female patients over the age of 40 who have undergone LSG operation have undergone mammography as of 2022. For this reason, the data of these patients will be examined by scanning from the hospital system. Patients who have undergone mammography examination at least 3 years after the LSG operation will be included in the study. The mammograms of the patients who underwent mammography in January 2015 and later will be evaluated. The final diagnosis of breast cancer will be made with the pathology result in patients with suspicious appearance on mamagrophy.

If there is a malignancy detected as a result of the examinations, its size and pathology will be recorded. Patients' age, gender, and total weight loss will be recorded.

In this retrospective study, we aimed to determine the incidence of breast cancer in patients who had undergone LSG surgery and also to determine whether there was a change in breast cancer compared to weight loss.

The patient inclusion criteria are as follows:

  • 40 years and older (age as of 2022, not the age of operation)
  • LSG was applied in our clinic due to morbid obesity.
  • Patients whose mamagrofi images are available in the hospital system

The patient exclusion criteria are as follows:

  • Patients who underwent abdominal surgery again after LSG
  • Patients whose mamagrophy image is not in the system
  • Patients with suspicious findings as a result of mammography and who did not undergo additional imaging or biopsy
  • Patients out of follow-up after the operation

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.

Study Contact

Study Locations

  • Turkey
      • Istanbul, Turkey, 34734
        • fatih sultan mehmet research and training hospital
        • Contact:

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

female patients over 40 years of age

Description

Inclusion Criteria:

  • 40 years and older (age as of 2022, not the age of operation)
  • LSG was applied in our clinic due to morbid obesity.
  • Patients whose mamagrofi images are available in the hospital system

Exclusion Criteria:

  • Patients who underwent abdominal surgery again after LSG
  • Patients whose mamagrophy image is not in the system
  • Patients with suspicious findings as a result of mammography and who did not undergo additional imaging or biopsy
  • Patients out of follow-up after the operation

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: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
significant weight loss+ breast cancer
The group that lost significant weight after laparoscopic sleeve gastrectomy and was diagnosed with breast cancer
Diagnostic test: mammography
All patients are checked for mammography every year after surgery.
regain+breast cancer
The group who lost significant weight after laparoscopic sleeve gastrectomy and regained it afterwards, or who could not lose weight and were diagnosed with breast cancer
Diagnostic test: mammography
All patients are checked for mammography every year after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
breast cancer incidence after laparoscopic sleeve gastrectomy
Time Frame: 5 year
Comparison of breast cancer incidence in those who lost weight after laparoscopic sleeve gastrectomy and those who did not.
5 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
breast cancer incidance
Time Frame: 5 year
Comparison of breast cancer incidence in those who lose weight after laparoscopic sleeve gastrectomy with the normal population
5 year

Collaborators and Investigators

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

Sponsor

Fatih Sultan Mehmet Training and Research Hospital

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)

December 15, 2022

Primary Completion (Anticipated)

January 1, 2026

Study Completion (Anticipated)

May 1, 2026

Study Registration Dates

First Submitted

December 8, 2022

First Submitted That Met QC Criteria

December 8, 2022

First Posted (Actual)

December 16, 2022

Study Record Updates

Last Update Posted (Actual)

December 16, 2022

Last Update Submitted That Met QC Criteria

December 8, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANILERGİNN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

If there is a request for the sharing of data, it will be shared.

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.

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