Biomarkers of Fatigue Related to Adjuvant Chemotherapy for Breast Cancer
NCT ID: NCT02041364
Last Updated: 2014-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
45 participants
OBSERVATIONAL
2013-11-30
2014-03-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Control: patients without fatigue
Patients whose scores on the brief fatigue inventory (BFI) (15) won't increase after having received the first cycle of chemotherapy will be considered as controls
No interventions assigned to this group
Patients with fatighe
Patients whose scores on the brief fatigue inventory (BFI) (15) increase after having received the first cycle of chemotherapy will be considered as having manifested fatigue
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing adjuvant chemotherapy
Exclusion Criteria
* Depression;
* anemia;
* heart disease or decompensated hypertension
18 Years
80 Years
FEMALE
No
Sponsors
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Faculdade de Medicina do ABC
OTHER
Responsible Party
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Felipe Melo Cruz
PhD
Principal Investigators
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Felipe M Cruz, PhD
Role: PRINCIPAL_INVESTIGATOR
551134744249
Locations
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Cepho-Fmabc
Santo André, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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Cruz FM, Munhoz BA, Alves BC, Gehrke FS, Fonseca FL, Kuniyoshi RK, Cubero D, Peppone LJ, Del Giglio A. Biomarkers of fatigue related to adjuvant chemotherapy for breast cancer: evaluation of plasma and lymphocyte expression. Clin Transl Med. 2015 Feb 14;4:4. doi: 10.1186/s40169-015-0051-8. eCollection 2015.
Other Identifiers
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Biomarker fatigue ABC001
Identifier Type: -
Identifier Source: org_study_id
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