The goal of the study is to explore the efficacy and safety of hyperbaric oxygen in the neoadjuvant treatment of breast cancer patients
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
161
Patients who meet the inclusion criteria will be enrolled and given hyperbaric oxygen intervention, with a minimum of 5 hyperbaric oxygen treatments per chemotherapy cycle, one per day for 60-90 minutes, for a total of 30-40 hyperbaric oxygen treatments (100% oxygen at a pressure of 2.0 ATA).
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGGuangdong Provincial People's Hospital
Shantou, Guangdong, China
RECRUITINGpCR rate after hyperbaric oxygen combined with neoadjuvant therapy in breast cancer patients
pCR rate after hyperbaric oxygen combined with neoadjuvant therapy in breast cancer patients
Time frame: After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)
The Miller and payne classification
Time frame: After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)
RCB 0/1 rate
RCB (Residual Cancer Burden) is a commonly used metric to assess the extent of residual tumor burden after neoadjuvant therapy, such as chemotherapy, radiation therapy, or targeted therapy. RCB 0: Complete response (CR) - No visible residual tumor, complete disappearance of the tumor. RCB I: Minimal residual disease - Only a small amount of residual tumor remains, with limited tumor volume and few lymph node metastases. RCB II: Moderate residual disease - Moderate degree of tumor residual is present. RCB III: Extensive residual disease - A large amount of residual tumor remains, often with more lymph node metastases.
Time frame: After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)
RECIST criteria
Time frame: After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)
life quality
Time frame: At the time of patient enrolment, Each cycle of chemotherapy (8cycle, each cycle is 3 weeks), Day before surgery, 3 months after surgery.
Side effects of hyperbaric oxygen therapy
Time frame: during the hyperbaric oxygen therapy (up to half a year)
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Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: through study completion ( an average of half a year)
the Tumor immune microenvironment of the Hyperbaric Oxygen Therapy and neoadjuvant therapy
Time frame: the time when the patient enrollment, at the end of the first cycle of neoadjuvant therapy (at about the first month), surgery