Breast CancerNCT06741540
Effects of TDCS Intervention on Neoadjuvant Chemotherapy in Breast Cancer Patients with Mild to Moderate Depression
A study testing tDCS in people with Breast Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- tDCS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 310009
Jun Pan, PhD, +8657189713716, amispan@zju.edu.cn
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- tDCS
- Keywords
- Breast Cancer, Neoadjuvant Chemotherapy, Depression, Transcranial Direct Current Stimulation
- Medical subject headings
- Breast Neoplasms, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective remission rate (ORR)
Objective remission rate (ORR) of neoadjuvant treatment
Measured: 18 weeks or 24 weeks, accroding to the neoadjuvant treatment completion
Secondary outcomes (5)
pathological complete remission rate (pCR)
Pathological complete remission rate (pCR)
Measured: 18 weeks or 24 weeks, after surgery completion, according to the neoadjuvant chemotherapy
HAMD score changes
Improvement in depression scores (HAMD score changes)
Measured: Evaluation was performed before and after neoadjuvant chemotherapy course (each course is 21 days)
BSGI
Changes in breast-specific gamma imaging (BSGI)
Measured: Every 2 cycles of neoadjuvant treatment (i.e., 6 weeks)
QoL
quality of life assessment after neoadjuvant chemotherapy, using the World Health Organization Quality of Life-brief Questionnaire (WHOQOL-BREF) .
Measured: 18 weeks or 24 weeks, accroding to the neoadjuvant treatment completion
ERP event-related potential detection
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.
Measured: 18 weeks or 24 weeks, accroding to the neoadjuvant treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start1 Jan 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Huang, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741540
- Sponsor's protocol ID
- 2024-1056
- Status last verified
- Nov 2024
- First submitted
- 29 Nov 2024
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of TDCS Intervention on Neoadjuvant Chemotherapy in Breast Cancer Patients with Mild to Moderate Depression
- ClinicalTrials.gov ID
- NCT06741540
- Acronym / sponsor ID
- 2024-1056
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Neoadjuvant Chemotherapy, Depression, Transcranial Direct Current Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: tDCSNeoadjuvant 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSTranscranial 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. | Other | tDCS with supportive psychotherapy group |
Primary outcome
Objective remission rate (ORR)
Time frame: 18 weeks or 24 weeks, accroding to the neoadjuvant treatment completion
Objective remission rate (ORR) of neoadjuvant treatment
5 secondary outcomes
pathological complete remission rate (pCR)
Time frame: 18 weeks or 24 weeks, after surgery completion, according to the neoadjuvant chemotherapy
HAMD score changes
Time frame: Evaluation was performed before and after neoadjuvant chemotherapy course (each course is 21 days)
BSGI
Time frame: Every 2 cycles of neoadjuvant treatment (i.e., 6 weeks)
QoL
Time frame: 18 weeks or 24 weeks, accroding to the neoadjuvant treatment completion
ERP event-related potential detection
Time frame: 18 weeks or 24 weeks, accroding to the neoadjuvant treatment completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jian Huang principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Breast Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Pan (+8657189713716, amispan@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective remission rate (ORR) (time frame: 18 weeks or 24 weeks, accroding to the neoadjuvant treatment completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.