Metabolic Syndrome and Female Breast Cancer

Metabolic Syndrome and Female Breast Cancer: a Case-control Study in Southern Brazil

The role among metabolic syndrome and breast cancer risk is not well understood and must be further explored. The objective of this study is to evaluate the association between metabolic syndrome and breast cancer in Southern Brazil. In this case-control study, breast cancer patients and controls without malignant disease, matched for age (±5 years) and menopausal status, were interviewed and asked to make a glucose, HDL-cholesterol and triglycerides test. Waist circumference and blood pressure were measured using standardized procedures. Metabolic Syndrome was considered by NCEP ATP III (2001) and IDF (2006) definitions. Cases and controls were compared in relation to the presence of diagnosed MetS (yes/no), number of metabolic abnormalities identified (1 to 5) for each definition, and according to each metabolic abnormality cutoff point.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Observation about the presence of metabolic syndrome

• Study Type: Observational
• Enrollment (Actual): 164

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Between December 2013 and August 2014, newly diagnosed (within 6 months) BC female patients referred to the oncology sector of the Teaching Hospital of the Federal University of Pelotas and to the Radiotherapy and Oncology Center of Santa Casa de Misericordia of Pelotas were invited to the study, before starting any adjuvant or neoadjuvant treatment. Women with a recidivated tumor, HIV infection, renal, heart or liver disease, hypothyroidism or hyperthyroidism, mobility or neurological limitations, chronicle use of corticosteroids, pacemakers or identified with severe edema were excluded. For each cancer case, one female control should be matched for age (± 5 years) and menopausal status (pre and post-menopausal). Apart from being free from all the exclusion criteria used for BC cases, controls should also have no signs of malignant disease. These women were invited to participate in the study while frequenting the Gynecologic Ambulatory of the same institutions, in the same period.

Description

Inclusion Criteria:

• For cases: having newly diagnosed breast cancer without adjuvant or neoadjuvant treatment;
• For controls: having no evidence of cancer; be matched for age and menopausal status with controls

Exclusion Criteria:

• Women with a recidivated tumor, HIV infection, renal, heart or liver disease, hypothyroidism or hyperthyroidism, mobility or neurological limitations, chronicle use of corticosteroids, pacemakers or identified with severe edema were excluded.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases; newly diagnosed (within 6 months) breast cancer patients, before adjuvant or neoadjuvant treatment.	Other: Observation about the presence of metabolic syndrome
Controls; patients without any malignant disease, matched for age an menopausal status with cases.	Other: Observation about the presence of metabolic syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Odds Ratio for Breast Cancer according to the presence of Metabolic Syndrome and its components	Participants will be evaluated only once before the first appointment with the oncologist (cases with a biopsy) and gynecologist (controls). The blood test results for Metabolic Syndrome parameters were collected in an expected average of 30 days.

Collaborators and Investigators

• Sponsor: Catholic University of Pelotas

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: October 17, 2014
• First Submitted That Met QC Criteria: October 31, 2014
• First Posted (Estimate): November 4, 2014

Study Record Updates

• Last Update Posted (Estimate): November 4, 2014
• Last Update Submitted That Met QC Criteria: October 31, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Metabolic syndrome; Breast cancer; case-control study
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Insulin Resistance; Hyperinsulinism; Breast Neoplasms; Metabolic Syndrome
• Other Study ID Numbers: 481.165