An interventional study of Hyperbaric oxygen treatment in Breast Cancers, sponsored by Guangdong Provincial People's Hospital. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-02-13.
Sponsored by Guangdong Provincial People's Hospital · Not applicable, Interventional, and Treatment
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
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 55 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Guangdong Provincial People's Hospital is the lead sponsor of 237 studies on the registry; 102 are open to participants now.
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Exclusion Criteria:
Patients who meet the inclusion criteria will be enrolled and given hyperbaric oxygen intervention, with a minimum of 5 times 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).
Device: Hyperbaric oxygen treatment
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).
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
This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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