Biomarkers of Fatigue Related to Adjuvant Chemotherapy for Breast Cancer
1 other identifier
observational
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 18, 2014
CompletedFirst Posted
Study publicly available on registry
January 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedJanuary 22, 2014
January 1, 2014
4 months
January 18, 2014
January 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Potential biomarkers related to chemotherapy induced fatigue
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
21 days after the start of chemotherapy
Study Arms (2)
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
Eligibility Criteria
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.
You may qualify if:
- Non metastatic breast cancer;
- Patients undergoing adjuvant chemotherapy
You may not qualify if:
- hypothyroidism;
- Depression;
- anemia;
- heart disease or decompensated hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cepho-Fmabc
Santo André, São Paulo, 09030-310, Brazil
Related Publications (1)
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.
PMID: 25852820DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Felipe M Cruz, PhD
551134744249
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
January 18, 2014
First Posted
January 22, 2014
Study Start
November 1, 2013
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
January 22, 2014
Record last verified: 2014-01