Breast Cancer
Conditions
Keywords
Breast Cancer, Neoadjuvant Chemotherapy, Depression, Transcranial Direct Current Stimulation
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.
Interventions
OTHERtDCS
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.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective remission rate (ORR) | 18 weeks or 24 weeks, accroding to the neoadjuvant treatment completion | Objective remission rate (ORR) of neoadjuvant treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HAMD score changes | Evaluation was performed before and after neoadjuvant chemotherapy course (each course is 21 days) | Improvement in depression scores (HAMD score changes) |
| pathological complete remission rate (pCR) | 18 weeks or 24 weeks, after surgery completion, according to the neoadjuvant chemotherapy | Pathological complete remission rate (pCR) |
| BSGI | Every 2 cycles of neoadjuvant treatment (i.e., 6 weeks) | Changes in breast-specific gamma imaging (BSGI) |
| QoL | 18 weeks or 24 weeks, accroding to the neoadjuvant treatment completion | quality of life assessment after neoadjuvant chemotherapy, using the World Health Organization Quality of Life-brief Questionnaire (WHOQOL-BREF) . |
| ERP event-related potential detection | 18 weeks or 24 weeks, accroding to the neoadjuvant treatment completion | Event-Related Potentials (ERP) are electrophysiological measures of the brain's electrical activity in response to specific events or stimuli, recorded via electroencephalography (EEG). They reflect cognitive processes and can be used to study various psychological phenomena with high temporal resolution, down to the millisecond. ERPs are valuable in clinical settings for assessing cognitive functions and are used in various fields, including psychiatry and neurology, to understand brain processing and diagnose conditions. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Molecular typing of breast cancer | 18 weeks or 24 weeks, through neoadjuvant treatment completion | Stratified analysis based on breast cancer molecular typing. Estrogen receptor (ER), progesterone receptor (PgR), Ki-67 labeling index and HER2 expression were evaluated by immunohistochemistry. A molecular subtype classification in five categories was adopted based upon the immunohistochemical assessment of ER, PgR, HER2 and Ki-67 according to the 2011 San Gallen consensus conference. |
| Population characteristics | 18 weeks or 24 weeks, through neoadjuvant treatment completion | Information about population characteristics, including age, BMI, menstrual status, and previous medical conditions. |
| Immune components | Evaluation was performed at Day 1 of each course, up to 18 weeks or 24 weeks, through neoadjuvant treatment completion | Tumor immune-related indicators in peripheral blood of patients, such as immune cell components, CRP, and cytokines (TNF-α, IL-6, IL-1, etc) |
| Hormone levels | Evaluation was performed at Day 1 of each course, up to 18 weeks or 24 weeks, through neoadjuvant treatment completion | Stress-related hormones, such as thyroxine, cortisol, adrenocorticotropin, etc |
Countries
China
Contacts
Primary ContactJun Pan
Backup ContactJian Huang
Outcome results
None listed