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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperbaric Oxygen group | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric oxygen treatment | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| RCB 0/1 rate | After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year) |
| Measure | Description | Time Frame |
|---|---|---|
| pCR rate after hyperbaric oxygen combined with neoadjuvant therapy in breast cancer patients | After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year) | |
| The Miller and payne classification | After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kun wang | Contact | 86+13829694500 | gzwangkun@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | China |
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| RECIST criteria | 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) | 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 | during the hyperbaric oxygen therapy (up to half a year) |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | through study completion ( an average of half a year) |
| the Tumor immune microenvironment of the Hyperbaric Oxygen Therapy and neoadjuvant therapy | the time when the patient enrollment, at the end of the first cycle of neoadjuvant therapy (at about the first month) , surgery |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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