Breast cancer
Conditions
Interventions
Hyperbaric Oxygen group:Hyperbaric Oxygen group
Sponsors
Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences)
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Understand the study process, participate in the study voluntarily, and sign the informed consent form. 2. patients with histopathologically confirmed initial unilateral primary invasive breast cancer, occult breast cancer, Patients with histopathologically confirmed initial unilateral primary invasive breast cancer, with the exception of occult breast cancer, inflammatory breast cancer and eczema-like carcinoma; 3. aged >= 18 years and = 55%; 7. Adequate bone marrow functional reserve: white blood cell count >=3.0 x 10^9/L, neutrophil count >=1.5 x 10^9/L; and 1.5 x 10^9/L; platelet count >= 100 x 10^9/L; haemoglobin >= 90 g/L; 8. AST, ALT <= 2.5 times the upper limit of normal value, alkaline phosphatase <= 2.5 times the upper limit of normal value. Total bilirubin <= 1.5 times the upper limit of normal value; serum creatinine <= 1.5 times the upper limit of normal value; 9. For non-menopausal or non-surgically sterilised female patients: during treatment and at least 7 months after the last dose of study treatment. For non-menopausal or non-surgically sterilised female patients: consent to contraception during treatment and for at least 7 months after the last dose of study treatment.
Exclusion criteria
Exclusion criteria: 1. Contraindication to hyperbaric oxygen therapy: untreated pneumothorax. Concurrent use of disulfiram. concomitant administration of anti-tumour drugs such as bleomycin, cisplatin, adriamycin concomitant administration of antineoplastic drugs such as bleomycin, cisplatin, adriamycin. Premature and/or low body mass neonates. Lung disease (severe chronic obstructive pulmonary disease). Diseases of the lungs (severe chronic obstructive airway disease, herpetic lung disease, acute or chronic lung infections, uncontrolled asthma, uncontrolled diarrhoea). controlled asthma, untreated pneumothorax), history of previous middle ear surgery, middle ear disease (eustachian tube Dysfunction of the eustachian tube, recurrent episodes of vertigo), ocular disease (retinal detachment). 2. previous hyperbaric oxygen therapy. 3. distant metastases, including lymph node metastases to the contralateral breast and mediastinum. 4. other malignant tumours within the last two years, except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix. Tumour. 5. pregnancy or lactation; 6. uncontrolled hypertension, cardiac, hepatic, renal related disease or other medical or psychiatric conditions. 7. major surgical procedure unrelated to breast cancer within 4 weeks prior to randomisation, or the patient has not fully recovered from such procedure; or has not fully recovered from such surgical intervention. 8. serious or uncontrolled infections that may interfere with study treatment or assessment of study results, including but not limited to Serious or uncontrolled infections that may interfere with study treatment or the evaluation of study results, including but not limited to active hepatitis virus infection, human immunodeficiency virus (HIV) antibody positivity, and pulmonary infections. 9. recent history of thromboembolism and taking full dose anticoagulant medication. 10. any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR rate after hyperbaric oxygen combined with neoadjuvant therapy in breast cancer patients; | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effects of hyperbaric oxygen therapy;Changes in tumor microenvironment before and after hyperbaric oxygen combined with neoadjuvant therapy versus tumor microenvironment with neoadjuvant therapy only;Safety of the study;The Miller and payne classification;RECIST criteria;RCB;Life quality; | — |
Countries
China
Contacts
Public ContactKun Wang
Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences)
Outcome results
None listed