Home treatment combining brain stimulation and cognitive training for breast cancer-related depression
Intervention With Non-Invasive Brain Stimulation and Cognitive Training for Depressive Symptomatology Associated With Breast Cancer (ONCODEP)
This study is testing a new home treatment that combines brain stimulation and online brain training to see if it can help improve mood and thinking skills in breast cancer patients dealing with depression.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 30 Years to 65 Years |
| Sex | Female |
| Sponsor | University of Santiago de Compostela Academic / other |
| Drugs / interventions | Chemotherapy, Immunotherapy |
| Locations | 2 sites (Santiago De Compostela, A Coruña and 1 other locations) |
| Trial ID | NCT06053775 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate a home-delivered intervention that integrates Non-Invasive Brain Stimulation techniques, specifically transcranial direct and alternating current stimulation (tDCS and tACS), with Online Cognitive Training (OCT) to address depressive symptoms and cognitive decline in breast cancer patients. Participants will be divided into four groups to receive either OCT alone or in combination with active or sham tDCS/tACS. The study will assess the efficacy and feasibility of this intervention, as well as its medium and long-term effects on patients' mental health and cognitive functioning. Additionally, saliva samples will be collected to identify biomarkers that may predict treatment response.
Who should consider this trial
Good fit: Ideal candidates include early-stage breast cancer patients who are currently undergoing or have recently completed oncological treatment and are experiencing depressive symptoms.
Not a fit: Patients with metastatic breast cancer or a history of psychiatric or cognitive disorders prior to their cancer diagnosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the mental health and cognitive functioning of breast cancer patients experiencing depressive symptoms.
How similar studies have performed: Other studies utilizing non-invasive brain stimulation techniques have shown promise in treating depressive symptoms, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of breast cancer in early stages (life expectancy greater than 12 months). * Patients who are receiving or have finished (maximum 6 months prior to participation in the participating in the study) some type of oncological treatment (Chemotherapy, Radiotherapy, Immunotherapy, Hormonal Therapy). * Patients whose mother tongue is Galician or Spanish. * Ability to give informed consent. * Present depressive symptomatology: score of 4 or higher in the BDI-FS. * Ability to use WhastApp * Have access to some technology (desktop computer, laptop or tablet) and the Internet (Firefox or Chrome browsers). Exclusion Criteria: * Pregnant or breastfeeding women. * Patients with metastasis. * Patients with a history of psychiatric symptomatology (depressive disorder, bipolar,anxious, psychotic...) prior to the oncological process. * Patients with a history of cognitive impairment or dementia prior to the oncologic process. oncological process. * Patients with a history of neurosurgery, cortical lesions or neurological alterations prior to the oncological process. * Patients with history or current consumption of non-prescribed drugs. * Patients with the following medication regimen: mood stabilizers, antipsychotics, anticonvulsants, l-dopa, rivastigmine, dextromethorphan, flunarizine, sulpiride, use of benzodiazepines (excluding long half-life benzodiazepines (Bromazepam, Diazepam) on a continuous/habitual basis,Alprazolam \>1mg per day, Lorazepam \>2mg per day). * Patients taking antidepressant medication should have a stable regimen ( same medication at the same dose for a minimum of four weeks prior to entering the study.The regimen with antidepressant drugs or drugs used as treatment to improve cognition should be kept stable during the entire participation (until the follow-up evaluation has been performed). * Patients unable to complete a neuropsychological examination. * Patients who are participating in a research study/clinical trial with drugs. * Patients who present any condition contraindicated to undergo tES (intracranial ferromagnetic devices or implanted stimulators; history of active epilepsy; history of neurosurgery, traumatic brain injury with loss of brainwith loss of consciousness and/or cortical lesion) (Antal et al., 2017)
Where this trial is running
Santiago De Compostela, A Coruña and 1 other locations
- University of Santiago de Compostela — Santiago De Compostela, A Coruña, Spain (Recruiting)
- Fundación Biomédica Galicia Sur — Vigo, Pontevedra, Spain (Not_yet_recruiting)
Study contacts
- Study coordinator: María Teresa Carrillo de la Peña
- Email: mteresa.carrillo@usc.es
- Phone: +34 647344231
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.