Clinical trial · Interventional
Reducing Breast Cancer-related Fatigue and Improving Cognition With Non-Invasive Brain Stimulation
NCT03143894CI-TRIAL-00051743terminatedN/AResults postedClinicalTrials.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): Poor accrual (inability to enroll participants)
Summary
Brief summary (as posted)
This study will test the preliminary efficacy of transcranial direct current stimulation (tDCS) to improve fatigue and cognition in women with a history of breast cancer and persistent fatigue.
Conditions
Conditions (3)
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 Dysfunction | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sham tDCS | Other | — | UNRESOLVED |
| tDCS | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Active tDCS first
- description
- 2 mA of active tDCS applied over a 30-minute study session once per day for 5 consecutive days then sham tDCS after washout.
- interventionNames
- Device: tDCS
- Other: Sham tDCS
- type
- SHAM_COMPARATOR
- label
- Sham tDCS first
- description
- Stimulation mimicking the tDCS applied only briefly over a 30-minute study session once per day for 5 consecutive days then active tDCS after washout.
- interventionNames
- Device: tDCS
- Other: Sham tDCS
Primary outcomes (1)
- measure
- Change on Paced Auditory Serial Attention Test (PASAT)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women, 18 years of age or older * Stage I-III breast cancer * Treatment Status: At least 6 months and no more than 5 years after the conclusion of active breast cancer therapy, including surgery, radiation therapy and (neo)adjuvant chemotherapy, if administered. NOTE: Adjuvant HER2-targeted therapy and endocrine therapy may still be ongoing at the time of study enrollment. * Fatigue: Moderate fatigue on most days within the past week (i.e., at least 4 out of the last 7 days), rated as ≥ 4 on a 0 (no fatigue) to 10 (worst fatigue) scale. * Able and willing to complete study tasks as evidenced by at least the following: fluent English speaker; hearing and language comprehension; and, sufficient literacy to complete study forms and questionnaires. * Patient understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form. Exclusion Criteria: * Evidence of recurrent breast cancer at the time of enrollment. * Depression or anxiety as defined either by ongoing pharmacological treatment for depression or anxiety or a HADS score on initial screening. * Dementia as assessed by a MMSE score on initial screening. * Known pregnancy or nursing. * Any of the following: diagnosis of schizophrenia or bipolar disorder made by a physician, seizure disorder, pacemaker, hearing aids, any metal implanted in the head, or the presence of other known current untreated causes of fatigue such as anemia or untreated hypothyroidism. * Use of stimulant medications, sleep medications, nicotine patch, and other drugs thought to interfere with tDCS efficacy for seven days prior to and during study participation. * Use of narcotic pain medication, benzodiazepines, or illicit drugs for seven days prior to and during study participation. * Consumption of \>14 alcoholic drinks per week or positive screening on the CAGE. * Skin conditions involving open sores on the scalp that would prevent proper application of the electrodes. * Hairstyles that obstruct placement of the electrodes including cornrows, dreadlocks, braids or other hair accessories that cannot be removed. * Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study.
References
Publications (0)
Data not yet available
No reference posted for this study.