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
  Purpose

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.


Condition
Fatigue
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Biomarkers of Fatigue Related to Adjuvant Chemotherapy for Breast Cancer: Evaluation of Plasma and Lymphocyte Expression.

Resource links provided by NLM:


Further study details as provided by Faculdade de Medicina do ABC:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 45
Study Start Date: November 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  • Non metastatic breast cancer;
  • Patients undergoing adjuvant chemotherapy

Exclusion Criteria:

  • hypothyroidism;
  • Depression;
  • anemia;
  • heart disease or decompensated hypertension
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02041364

Contacts
Contact: Felipe M Cruz, PhD 551144362094 felipemcruz@yahoo.com.br

Locations
Brazil
Cepho-Fmabc Recruiting
Santo Andre, Sao Paulo, Brazil, 09030-310
Contact: Felipe Cruz, PhD    551181388214    felipemcruz@yahoo.com.br   
Principal Investigator: Felipe M Cruz, PhD         
Sponsors and Collaborators
Faculdade de Medicina do ABC
Investigators
Principal Investigator: Felipe M Cruz, PhD 551134744249
  More Information

No publications provided

Responsible Party: Felipe Melo Cruz, PhD, Faculdade de Medicina do ABC
ClinicalTrials.gov Identifier: NCT02041364     History of Changes
Other Study ID Numbers: Biomarker fatigue ABC001
Study First Received: January 18, 2014
Last Updated: January 18, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by Faculdade de Medicina do ABC:
Fatigue
Biomarkers
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Fatigue
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014