Clinical trial NCT06741540: Effects of TDCS Intervention on Neoadjuvant Chemotherapy in Breast Cancer Patients with Mild to Moderate Depression
Official title: Effects of TDCS Intervention on Neoadjuvant Chemotherapy in Breast Cancer Patients with Mild to Moderate Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Neoadjuvant Chemotherapy
Depression
Transcranial Direct Current Stimulation
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Stress is the non-specific physiological and psychological response of the body to various stressors. Previous studies have proven that chronic stress is a recognized risk factor of tumors, participating in multiple stages such as tumor occurrence, development, metastasis, recurrence, and drug resistance. Epidemiological studies show that cancer patients often have chronic mental stress, accompanied by cognitive impairment, symptoms of depression and anxiety, and these patients have a poorer prognosis. Depression and anxiety are also associated with higher incidence of tumors, cancer-specific mortality, and all-cause mortality.

Breast cancer has become the most common malignant tumor in women, accounting for about 30% of new cancer cases in women. Since 1991, the mortality rate of breast cancer in women worldwide has slowed down due to the rapid development of screening and early diagnosis and treatment methods. It is worth noting that in China, breast cancer is still the leading cause of cancer in women, and its mortality rate is still on the rise. 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.

This evidence proves that stress factors should not be ignored in the clinical process of tumor prevention and treatment. Our clinical practice has found that in addition to drug treatment, psychological and physical therapies are also effective for stress disorders. 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). Both the experimental and control groups will receive supportive psychotherapy during the treatment process (mainly to provide psychological support for patients). The primary study endpoint is the objective remission rate (ORR) of neoadjuvant treatment, and the secondary study endpoints include pathological complete remission rate (pCR), improvement in depression scores (HAMD score changes), changes in breast-specific gamma imaging (BSGI), quality of life assessment after neoadjuvant chemotherapy, and ERP event-related potential detection. In addition, further exploratory research will be carried out, with stratified analysis based on breast cancer molecular typing, population characteristics, immune components, and changes in hormone levels.

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 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.

Primary outcomes:
measure: Objective remission rate (ORR)
timeFrame: 18 weeks or 24 weeks, accroding to the neoadjuvant treatment completion
Secondary outcomes:
measure: pathological complete remission rate (pCR)
timeFrame: 18 weeks or 24 weeks, after surgery completion, according to the neoadjuvant chemotherapy
measure: HAMD score changes
timeFrame: Evaluation was performed before and after neoadjuvant chemotherapy course (each course is 21 days)
measure: BSGI
timeFrame: Every 2 cycles of neoadjuvant treatment (i.e., 6 weeks)
measure: QoL
timeFrame: 18 weeks or 24 weeks, accroding to the neoadjuvant treatment completion
measure: ERP event-related potential detection
timeFrame: 18 weeks or 24 weeks, accroding to the neoadjuvant treatment completion
Other outcomes:
measure: Molecular typing of breast cancer
timeFrame: 18 weeks or 24 weeks, through neoadjuvant treatment completion
measure: Population characteristics
timeFrame: 18 weeks or 24 weeks, through neoadjuvant treatment completion
measure: Immune components
timeFrame: Evaluation was performed at Day 1 of each course, up to 18 weeks or 24 weeks, through neoadjuvant treatment completion
measure: Hormone levels
timeFrame: Evaluation was performed at Day 1 of each course, up to 18 weeks or 24 weeks, through neoadjuvant treatment completion
Locations:
city: Hangzhou
country: China
facility: 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Jian Huang
role: PRINCIPAL_INVESTIGATOR
References: