Biomarkers of Fatigue Related to Adjuvant Chemotherapy for Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Faculdade de Medicina do ABC
Sponsor:
Information provided by (Responsible Party):
Felipe Melo Cruz, Faculdade de Medicina do ABC
ClinicalTrials.gov Identifier:
NCT02041364
First received: January 18, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted

January 18, 2014
January 18, 2014
November 2013
March 2014   (final data collection date for primary outcome measure)
Potential biomarkers related to chemotherapy induced fatigue [ Time Frame: 21 days after the start of chemotherapy ] [ Designated as safety issue: No ]
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
Same as current
No Changes Posted
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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.

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.

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

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Patients with stage I, II and III breast cancer undergoing adjuvant systemic chemotherapy based on the use of anthracyclines will be screened before the start of their treatment.

  • Fatigue
  • Breast Cancer
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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
  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
March 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Non metastatic breast cancer;
  • Patients undergoing adjuvant chemotherapy

Exclusion Criteria:

  • hypothyroidism;
  • Depression;
  • anemia;
  • heart disease or decompensated hypertension
Female
18 Years to 80 Years
No
Contact: Felipe M Cruz, PhD 551144362094 felipemcruz@yahoo.com.br
Brazil
 
NCT02041364
Biomarker fatigue ABC001
No
Felipe Melo Cruz, Faculdade de Medicina do ABC
Faculdade de Medicina do ABC
Not Provided
Principal Investigator: Felipe M Cruz, PhD 551134744249
Faculdade de Medicina do ABC
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP