Clinical trial · Observational
Fatigue Caused by Chemotherapy in Women Who Have Undergone Surgery for Breast Cancer and in Healthy Volunteers
Physiology of Chemotherapy Induced Fatigue and Cognitive Dysfunction in Early Stage Breast Cancer
NCT00909662CI-TRIAL-00019321terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding unavailable
Summary
Brief summary (as posted)
RATIONALE: Gathering information over time from women undergoing chemotherapy for breast cancer may help doctors learn more about mental and physical fatigue caused by treatment. PURPOSE: This clinical trial is studying fatigue caused by chemotherapy in women who have undergone surgery for stage I, stage II, or stage III breast cancer and in healthy volunteers.
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 |
| Cognitive/Functional Effects | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
| Long-term Effects Secondary to Cancer Therapy in Adults | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| assessment of therapy complications | Procedure | — | UNRESOLVED |
| cognitive assessment | Procedure | — | UNRESOLVED |
| fatigue assessment and management | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Patients
- description
- Female patients with operable breast cancer intending to undergo adjuvant chemotherapy
- interventionNames
- Procedure: assessment of therapy complications
- Procedure: cognitive assessment
- Procedure: fatigue assessment and management
- label
- Participants
- description
- Female control subjects will be recruited, consisting predominantly of age-matched (i.e.+/- 10 years of age) friends or family members of the patients.
- interventionNames
- Procedure: assessment of therapy complications
- Procedure: cognitive assessment
- Procedure: fatigue assessment and management
Primary outcomes (5)
- measure
- Treatment-related fatigue as assessed by a brief fatigue inventory, a Brief Mental Fatigue Questionnaire, and a motor fatigability task with concurrent physiological measurements at baseline, during treatment, and 1 year after treatment completion
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Meets either of the following criteria:
* Has completed surgery for stage I-III breast cancer AND meets the following criteria:
* No bilateral axillary dissection
* Clinically free of active disease
* Planning to receive adjuvant chemotherapy for operable breast cancer
* Friend or relative of patient matched for age (± 10 years) (control)
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Known menopausal status
* Able to read English
* No history of significant cardiovascular disease or stroke, polyneuropathy, amyotrophy, myosthenic syndrome, or pulmonary compromise
* Prior depression allowed provided that it was not significant
* Willing to come to the Cleveland Clinic for 3 assessments
PRIOR CONCURRENT THERAPY:
* See Disease CharacteristicsReferences
Publications (0)
Data not yet available
No reference posted for this study.