The goal of the study is to explore the efficacy and safety of hyperbaric oxygen therapy in the neoadjuvant treatment of triple-negative and HER2+ breast cancer patients
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
348
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, China
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 the first cycle of neoadjuvant therapy (at about 1 month), After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)
Life quality (EORTC QLQ C-30、EORTC QLQ BR-23 questionnaire)
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