Biomarkers of Fatigue Related to Adjuvant Chemotherapy for Breast Cancer

• Conditions: Fatigue; Breast Cancer

• Registration Number: NCT02041364
• Lead Sponsor: Faculdade de Medicina do ABC

Brief Summary

Fatigue is common in cancer patients receiving adjuvant chemotherapy. To further understand the mechanism of fatigue and search for potential biomarkers, we will conduct a prospective study with breast cancer patients receiving adjuvant chemotherapy.

Detailed Description

Patients with breast cancer undergoing adjuvant systemic chemotherapy based on the use of anthracyclines will be screened before the start of chemotherapy.

Patients whose scores on the brief fatigue inventory (BFI) increase after having received the first cycle of chemotherapy will be considered as having manifested fatigue. The patients whose fatigue won't worse following the first cycle of chemotherapy will be used as controls. We will collect blood samples of both groups before and 21 days after the start of chemotherapy. We will analyze the following biomarkers: IL2, IL10, TNF and TGFB-1 measured by amplification reaction; FSH, LH, estradiol, DHEA, DHEAS and cortisol hormones measured by chemiluminescent enzyme immunometric assay

Study Timeline

• Study Start: 2013-11
• Status Verified: 2014-01
• Study First Submitted: 2014-01-18
• Study First Submitted QC: 2014-01-18
• Last Update Submitted: 2014-01-18
• Study First Posted: 2014-01-22
• Last Update Posted: 2014-01-22
• Primary Completion: 2014-03
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 45

Inclusion Criteria

• Non metastatic breast cancer;
• Patients undergoing adjuvant chemotherapy

Exclusion Criteria

• hypothyroidism;
• Depression;
• anemia;
• heart disease or decompensated hypertension

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Potential biomarkers related to chemotherapy induced fatigue	21 days after the start of chemotherapy	This study examines potential biomarkers of fatigue induced by chemotherapy both in the plasma and mononuclear fraction of the peripheral blood of patients with breast cancer

Trial Locations

Locations (1)

Cepho-Fmabc; 🇧🇷 Santo Andre, Sao Paulo, Brazil