Prevalence, Severity and Determinants of Cancer-related Fatigue (CRF) in Asian Breast Cancer Patients
NCT ID: NCT02304640
Last Updated: 2020-09-11
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
194 participants
OBSERVATIONAL
2014-10-31
2020-12-31
Brief Summary
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Detailed Description
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This will be a multicenter, prospective, longitudinal, observational study conducted at the National Cancer Centre Singapore and KK Women's and Children's Hospital. Informed consent will be obtained from participants before the investigators proceed with data collection.
The study participants will be assessed at relevant time points. Biological determinants and symptoms associated with CRF will be assessed. The associations between changes in CRF, plasma cytokines levels, serum cortisol levels, and other clinical determinants will be elucidated.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Early-stage breast cancer patients
No interventions assigned to this group
Healthy control
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Stage I-III breast cancer
* Chinese, Malay or Indian ethnics
* Surgical treatment has been performed
* Scheduled to receive four cycles of chemotherapy (doxorubicin/cyclophosphamide \[AC\], docetaxel/cyclophosphamide \[TC\], 5-fluorouracil/epirubicin/cyclophosphamide \[FEC\]) (total duration of 3 months) and/or radiotherapy and/or hormonal therapy
* No prior history of chemotherapy and/or radiotherapy
* Able to read and understand either English or Mandarin
Exclusion Criteria
* Symptomatically ill (such as infection or an allergic reaction to chemotherapy)
* Presence of another condition for which fatigue is a prominent symptom (e.g. AIDS, fibromyalgia, or rheumatoid arthritis)
* Newly started on any medications that can cause general fatigue and body weakness (e.g. a beta-blocker or antidepressant, antihistamine, or antipsychotic medication)
* Presence of neurologic or immune-related medical condition or behavior known to influence the immune system (e.g. smoking or heavy drinking)
21 Years
FEMALE
Yes
Sponsors
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National University of Singapore
OTHER
Responsible Party
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Alexandre Chan
Associate Professor and Specialist Pharmacist (Oncology Pharmacy)
Locations
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Alexandre Chan
Singapore, , Singapore
Countries
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Other Identifiers
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2014/754/B
Identifier Type: -
Identifier Source: org_study_id
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