Using brain stimulation to help breast cancer patients with depression during chemotherapy

Effects of TDCS Intervention on Neoadjuvant Chemotherapy in Breast Cancer Patients with Mild to Moderate Depression

This study is testing if a gentle brain stimulation technique can help breast cancer patients feel less depressed during their chemotherapy treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: Female
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06741540 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of transcranial direct current stimulation (tDCS) on breast cancer patients who are undergoing neoadjuvant chemotherapy and experiencing mild to moderate depression. It aims to assess whether this non-invasive brain stimulation technique can improve psychological well-being and potentially enhance treatment outcomes. The study will include newly diagnosed breast cancer patients who meet specific criteria and will evaluate their emotional and physical responses to the intervention. By addressing the mental health challenges associated with cancer treatment, the study seeks to improve overall quality of life for participants.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 to 65 with newly diagnosed breast cancer and mild to moderate depression who are eligible for neoadjuvant chemotherapy.

Not a fit: Patients with severe physical illnesses, suicidal tendencies, or those who have recently received other treatments for depression may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve the mental health and treatment outcomes for breast cancer patients facing depression.

How similar studies have performed: Previous studies have shown promising results for tDCS in improving mental health outcomes in various patient populations, suggesting potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

* Age between 18 and 65 years old;
* Newly diagnosed and pathologically confirmed breast cancer patients;
* Meet the guidelines for neoadjuvant chemotherapy indications, have no contraindications, and accept neoadjuvant treatment;
* At least one measurable lesion that can be assessed according to RECIST 1.1 criteria;
* Positive initial emotional assessment (5≤PHQ9 score ≤14), ≥ 5 symptoms and have not undergone other treatments;
* Cardiopulmonary function can withstand surgery, no other severe diseases, and Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
* Informed and willing to participate in the study, and have signed the informed consent form.

Exclusion Criteria:

* Concurrent severe physical illnesses;
* Suicidal tendencies;
* Pregnant or breastfeeding;
* Received tDCS physical therapy, systemic psychotherapy, antidepressant medication, or other treatments for negative emotions within the past 6 months;
* Patients with brain trauma and other organic brain diseases, and other contraindications for tDCS;
* Severe anxiety with GAD7 score ≥10.

Where this trial is running

Hangzhou, Zhejiang

• 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Jian Huang — Second Affiliated Hospital, School of Medicine, Zhejiang University
• Study coordinator: Jun Pan

Conditions Breast Cancer; Neoadjuvant Chemotherapy; Depression; Transcranial Direct Current Stimulation