The goal of this study is to explore the efficacy and safety of hyperbaric oxygen in the neoadjuvant treatment of hormone receptor positive breast cancer patients
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
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
RCB 0/1 rate
Time frame: After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)
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)
RECIST criteria
Time frame: After completion of the first cycle of adjuvant therapy, 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 (8 cycle, 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)
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
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