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Biomarkers of Fatigue Related to Adjuvant Chemotherapy for Breast Cancer

Biomarkers of Fatigue Related to Adjuvant Chemotherapy for Breast Cancer: Evaluation of Plasma and Lymphocyte Expression.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02041364
Enrollment
45
Registered
2014-01-22
Start date
2013-11-30
Completion date
2014-03-31
Last updated
2014-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Fatigue

Keywords

Fatigue, Biomarkers, Breast Cancer

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

Interventions

None listed

Sponsors

Faculdade de Medicina do ABC
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Non metastatic breast cancer; * Patients undergoing adjuvant chemotherapy

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Potential biomarkers related to chemotherapy induced fatigue21 days after the start of chemotherapyThis 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

Countries

Brazil

Contacts

Primary ContactFelipe M Cruz, PhD
felipemcruz@yahoo.com.br551144362094

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026