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Biomarkers of Fatigue Related to Adjuvant Chemotherapy for Breast Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2014 by Felipe Melo Cruz, Faculdade de Medicina do ABC.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02041364
First Posted: January 22, 2014
Last Update Posted: January 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Felipe Melo Cruz, Faculdade de Medicina do ABC
January 18, 2014
January 22, 2014
January 22, 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 ]
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
Not Provided
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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
Not Provided
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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
Not Provided
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
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
Sexes Eligible for Study: Female
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT02041364
Biomarker fatigue ABC001
No
Not Provided
Not Provided
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