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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02304640 |
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Date of registration:
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21/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Prevalence, Severity and Determinants of Cancer-related Fatigue (CRF) in Asian Breast Cancer Patients
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Scientific title:
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Prevalence, Severity and Determinants of Cancer-related Fatigue (CRF) in Asian Breast Cancer Patients |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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194 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02304640 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Singapore
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- At least 21 years of age
- 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:
- Physically or mentally unable to provide verbal/written consent
- 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)
Age minimum:
21 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Chemotherapy
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Supportive Care
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Breast Cancer
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Fatigue
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Primary Outcome(s)
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Incidence of cancer-related fatigue
[Time Frame: One year post chemotherapy]
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Secondary Outcome(s)
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Incidence of cognitive impairment
[Time Frame: One year post chemotherapy]
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Secondary ID(s)
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2014/754/B
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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