Metabolic Syndrome and Female Breast Cancer

Completed

• Conditions: Breast Cancer
• Interventions: Other: Observation about the presence of metabolic syndrome

• Registration Number: NCT02282592
• Lead Sponsor: Catholic University of Pelotas

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Primary Completion: 2014-08
• Status Verified: 2014-10
• Study Completion: 2014-10
• Study First Submitted: 2014-10-17
• Study First Submitted QC: 2014-10-31
• Last Update Submitted: 2014-10-31
• Study First Posted: 2014-11-04
• Last Update Posted: 2014-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 164

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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.