A Phase II Single-Arm Clinical Study to Explore the Efficacy and Safety of Hyperbaric Oxygen in the Neoadjuvant Treatment of Triple-Negative and HER2+ Breast Cancer Patients

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status: Not yet enrolling

Conditions: Breast Cancers

Treatments: Device: Hyperbaric oxygen treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06825975

KY2024-1118-02

Details and patient eligibility

About

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

Enrollment: 348 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Understand the study process, participate in the study voluntarily, and sign the informed consent form.

2. have an initial histopathologically confirmed diagnosis of unilateral primary invasive breast cancer, excluding occult breast cancer, inflammatory breast cancer and eczema-like carcinoma

3. aged ≥ 18 years and ≤ 60 years, female

4. patients who meet the inclusion criteria of neoadjuvant therapy to receive neoadjuvant therapy for breast cancer (patients with locally advanced breast cancer (AJCC Stage III, except T3N1M0) or operable but not in breast-conserving or axillary-sparing condition (Stage IIA-IIB and T3N1M0), or patients with a certain tumour load of HER2-positive or TNBC with clinical lymph node positivity, or patients with a tumour size of 2cm and above). or tumour size 2cm and above).

5. ECOG performance status 0-1.

6. LVEF ≥ 55%

7. Adequate bone marrow functional reserve: white blood cell count ≥3.0 x 109/L, neutrophil count ≥1.5 x 109/L; platelet count ≥100 x 109/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: consent to contraception during treatment and for at least 7 months after the last dose of the study treatment

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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348 participants in 1 patient group

Hyperbaric Oxygen group

Experimental group

Description:

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).

Treatment:

Device: Hyperbaric oxygen treatment