Effects of TDCS Intervention on Neoadjuvant Chemotherapy in Breast Cancer Patients with Mild to Moderate Depression
Recruiting · NCT06741540 · Interventional (participants receive a specific treatment) · Lead sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Depression and anxiety are associated with higher incidence of tumors, cancer-specific mortality, and all-cause mortality. Compared with patients with other types of cancer, breast cancer patients often accompany physical damage, changes in physiological status, decline in quality of life, sensitivity in interpersonal relationships, and side effects of drug treatment during the occurrence, development, and treatment of cancer, leading to long-term chronic mental stress. The prevalence of depression and anxiety in early-stage breast cancer patients in China is as high as 44.1% and 35.2%, respectively. A meta-analysis based on 282,203 breast cancer patients suggests that depression is related to breast cancer-specific mortality, and patients with breast cancer and depression have a poorer prognosis. Intervention in response to stressors may improve psychological and physiological adaptation processes and even benefit quality of life and clinical health outcomes. More and more randomized controlled trials focus on improving the quality of life and adverse reactions of cancer patients after stress management, but there are few reports on the direct improvement of anti-tumor efficacy. Therefore, we plan to conduct a small sample, exploratory, randomized controlled study to clarify the impact of transcranial direct current stimulation (tDCS) intervention on the efficacy of neoadjuvant chemotherapy in breast cancer patients with depressive symptoms. Newly diagnosed breast cancer patients will be assessed for emotions by mental health professionals, with a PHQ9 score of 5-14 and ≥ 5 symptoms considered positive, combined with enrollment criteria for screening. Patients who meet the enrollment criteria will be randomly divided into the control group (i.e., supportive psychotherapy group) and the experimental group (i.e., tDCS + supportive psychotherapy group). The primary study endpoint is the objective remission rate (ORR) of neoadjuvant treatment. This study aims to improve the depressive state of breast cancer patients undergoing neoadjuvant chemotherapy through physical therapy (tDCS) and to clarify whether there is a correlation between emotional intervention and neoadjuvant efficacy.
Who can take part
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 it is running
1 location listed.
- 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China - Hangzhou, Zhejiang, China