Clinical trial · Observational
Prevalence, Severity and Determinants of Cancer-related Fatigue (CRF) in Asian Breast Cancer Patients
NCT02304640CI-TRIAL-00047111unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
There is a paucity of studies that focus on the symptom burden of cancer patients in Singapore, particularly the clinical effects of cancer-related fatigue (CRF). Knowing that early-stage breast cancer is curable, it is of paramount importance to evaluate the clinical and biological determinants of lingering symptoms in breast cancer survivors so that appropriate psychosocial interventions can be formulated.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemotherapy | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
| Supportive Care | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Early-stage breast cancer patients
- label
- Healthy control
Primary outcomes (1)
- measure
- Incidence of cancer-related fatigue
- timeFrame
- One year post chemotherapy
- description
- MFSI-SF will be used. This is a multidimensional questionnaire for measuring fatigue in cancer patients that has been validated in a group of breast cancer patients undergoing anticancer treatment. It consists of 30 items and has five subscales, each with six items: general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor. The MFSI-SF measures different dimensions of fatigue, which can be combined to obtain an overall score. It has favorable psychometric properties with internal consistency reliability within the range of 0.87 to 0.96 and established convergent and divergent validity. As such, it is an appropriate tool for measuring fatigue.
Secondary outcomes (1)
- measure
- Incidence of cognitive impairment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.