Using hyperbaric oxygen to treat breast cancer before surgery

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

This study is testing if hyperbaric oxygen therapy can help shrink breast tumors in women aged 18 to 60 before they have surgery.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 161 (estimated)
• Ages: 18 Years to 60 Years
• Sex: Female
• Sponsor: Guangdong Provincial People's Hospital (other)
• Locations: 2 sites (Guangzhou, Guangdong and 1 other locations)
• Trial ID: NCT06811870 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of hyperbaric oxygen therapy as a neoadjuvant treatment for patients with breast cancer. It involves administering hyperbaric oxygen to women aged 18 to 60 with specific types of breast cancer prior to surgical intervention. The study will assess how this treatment impacts tumor size and overall patient outcomes. Participants must meet certain health criteria and provide informed consent to join the trial.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 to 60 with histopathologically confirmed locally advanced or operable breast cancer.

Not a fit: Patients with inflammatory breast cancer, eczema-like carcinoma, or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve the effectiveness of neoadjuvant therapy for breast cancer patients, potentially leading to better surgical outcomes.

How similar studies have performed: While hyperbaric oxygen therapy has been explored in various contexts, this specific application in neoadjuvant breast cancer treatment is relatively novel.

Eligibility 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 ≤ 60 years, female
4. patients who meet the inclusion criteria for neoadjuvant therapy to receive neoadjuvant therapy for breast cancer (locally advanced) Patients with locally advanced breast cancer (AJCC stage III, except T3N1M0) or operable breast cancer, but without breast-conserving or axillary preservation (stage IIA-IIB and T3N1M0) or HER2 positive or TNBC with certain tumour load, or patients with clinical lymph node positivity or tumour size of 2cm and above.)
5. ECOG performance status 0-1. 6.
6. LVEF ≥ 55% 7.
7. Adequate bone marrow functional reserve: white blood cell count ≥3.0 x 109/L, neutrophil count ≥1.5 x 109/L; and 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: 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:

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

Where this trial is running

Guangzhou, Guangdong and 1 other locations

• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (NOT_YET_RECRUITING)
• Guangdong Provincial People's Hospital — Shantou, Guangdong, China (RECRUITING)

Study contacts

• Principal investigator: Kun Wang, PhD — Guangdong Provincial People's Hospital Guangzhou,
• Study coordinator: Kun Wang Kun Wang, PhD

Conditions: Breast Cancers