Clinical trial · Interventional
Cranial Stimulation for Chemotherapy Symptoms in Breast Cancer
- 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)
RATIONALE: Cranial microcurrent electrical stimulation (CES) is mild electrical current received through electrodes placed on the earlobes. CES may lessen symptoms in women with breast cancer receiving chemotherapy. It is not yet known whether CES is more effective than sham therapy in reducing symptoms caused by chemotherapy in women with breast cancer. PURPOSE: This randomized phase III trial is studying mild electrical stimulation to see how well it works compared with sham therapy in reducing symptoms caused by chemotherapy in women with stage I, stage II, or stage IIIA breast cancer receiving chemotherapy.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety Disorder | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Depression | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
| Sleep Disorders | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| energy-based therapy | Procedure | — | UNRESOLVED |
| sham intervention | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (cranial microcurrent electrical stimulation [CES])
- description
- Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.
- interventionNames
- Procedure: energy-based therapy
- type
- SHAM_COMPARATOR
- label
- Arm II (sham CES)
- description
- Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.
- interventionNames
- Procedure: sham intervention
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of stage I-IIIA breast cancer * Scheduled to receive adjuvant chemotherapy * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Pre, peri, or post-menopausal * ECOG performance status 0-1 * No dementia * No active psychosis * No history of seizure disorder * No implanted electrical device PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior chemotherapy * No initiation of a medication regimen for depression or other psychiatric condition within the past 30 days
References
Publications (1)
- DERIVEDLyon D, Kelly D, Walter J, Bear H, Thacker L, Elswick RK. Randomized sham controlled trial of cranial microcurrent stimulation for symptoms of depression, anxiety, pain, fatigue and sleep disturbances in women receiving chemotherapy for early-stage breast cancer. Springerplus. 2015 Jul 23;4:369. doi: 10.1186/s40064-015-1151-z. eCollection 2015. PMID 26435889