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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
RECRUITING
Hangzhou
Contact Information
Primary
Jun Pan
amispan@zju.edu.cn
+8657189713716
Backup
Jian Huang
drhuangjian@zju.edu.cn
+8657189713716
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 60
Treatments
No_intervention: Supportive psychotherapy group
Neoadjuvant chemotherapy with supportive psychotherapy and sham tDCS. A neoadjuvant chemotherapy regimen will be recommended to the patient based on the guidelines, combined with the patient's molecular typing and condition. Neoadjuvant chemotherapy lasts for 21 days per cycle, and the patient needs to be hospitalized for neoadjuvant chemotherapy once. During each neoadjuvant chemotherapy hospitalization, a full-time staff member will be arranged to perform sham tDCS treatment for the patient.~The rest of the treatment was consistent with the tDCS group, but no current passed through the head-mounted device in this group.~During the treatment,all patients in this group will recieve supportive psychotherapy, with mainly provide psychological support to patients.
Experimental: tDCS with supportive psychotherapy group
Neoadjuvant chemotherapy with supportive psychotherapy and tDCS. A neoadjuvant chemotherapy regimen will be recommended to the patient based on the guidelines, combined with the patient's molecular typing and condition. Neoadjuvant chemotherapy lasts for 21 days per cycle, and the patient needs to be hospitalized for neoadjuvant chemotherapy once. During each neoadjuvant chemotherapy hospitalization, a full-time staff member will be arranged to perform tDCS treatment for the patient. The treatment is a head-mounted device, which is performed 1 hour before neoadjuvant chemotherapy and 2 hours after neoadjuvant chemotherapy. Each tDCS treatment lasts about 30 minutes. The patient's activities are not affected during the treatment, and no additional harm or pain is caused to the patient. A total of 6 tDCS treatments are completed per cycle of neoadjuvant chemotherapy, and 36 tDCS treatments will be completed during the entire treatment process.
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University

This content was sourced from clinicaltrials.gov