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

NCT06741540 | Recruiting

• 1 other identifier: 2024-1056
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Objective remission rate (ORR)

  Objective remission rate (ORR) of neoadjuvant treatment

  18 weeks or 24 weeks, accroding to the neoadjuvant treatment completion

Secondary Outcomes (5)

• pathological complete remission rate (pCR)

  18 weeks or 24 weeks, after surgery completion, according to the neoadjuvant chemotherapy

• HAMD score changes

  Evaluation was performed before and after neoadjuvant chemotherapy course (each course is 21 days)

• BSGI

  Every 2 cycles of neoadjuvant treatment (i.e., 6 weeks)

• QoL

  18 weeks or 24 weeks, accroding to the neoadjuvant treatment completion

• ERP event-related potential detection

  18 weeks or 24 weeks, accroding to the neoadjuvant treatment completion

Other Outcomes (4)

• Molecular typing of breast cancer

  18 weeks or 24 weeks, through neoadjuvant treatment completion

• Population characteristics

  18 weeks or 24 weeks, through neoadjuvant treatment completion

• Immune components

  Evaluation was performed at Day 1 of each course, up to 18 weeks or 24 weeks, through neoadjuvant treatment completion

Study Arms (2)

Supportive psychotherapy group

NO INTERVENTION

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.

tDCS with supportive psychotherapy group

EXPERIMENTAL

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.

Other: tDCS

Interventions

tDCS OTHER

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that modulates cortical excitability by applying a weak direct current through electrodes placed on the scalp. This technique usually lasts for 20-30 minutes and can affect brain function by altering cortical excitability, local cerebral blood flow, synaptic plasticity, and the balance of cortical excitation/inhibition. tDCS is widely used in clinical settings and has shown some clinical efficacy in treating common psychiatric and neurological disorders. It is also used to improve motor, perceptual, and cognitive processes, as well as to treat a variety of neurological and psychiatric diseases.

tDCS with supportive psychotherapy group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Depression

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Jian Huang

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Pan

CONTACT

+8657189713716; amispan@zju.edu.cn

Jian Huang

CONTACT

+8657189713716; drhuangjian@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that modulates cortical excitability by applying a weak direct current through electrodes placed on the scalp. This technique usually lasts for 20-30 minutes and can affect brain function by altering cortical excitability, local cerebral blood flow, synaptic plasticity, and the balance of cortical excitation/inhibition. tDCS is widely used in clinical settings and has shown some clinical efficacy in treating common psychiatric and neurological disorders. It is also used to improve motor, perceptual, and cognitive processes, as well as to treat a variety of neurological and psychiatric diseases.

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 19, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 7, 2025

Record last verified: 2024-11

Locations

CN (1)