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

RECRUITINGPHASE1/PHASE2

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

NCT06811870•Guangdong Provincial People's Hospital

View on ClinicalTrials.gov

Summary

The goal of the study is to explore the efficacy and safety of hyperbaric oxygen in the neoadjuvant treatment of breast cancer patients

Eligibility

Age

18 - 60 years

Sex

FEMALE

Healthy Volunteers

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
•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.
+3 more criteria

Locations (2)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Guangdong Provincial People's Hospital

Shantou, Guangdong, China

Key Dates

Start Date

February 1, 2025

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2026

Last Updated

April 1, 2025

Enrollment

161

ESTIMATED participants

Conditions

Breast Cancers

Interventions

hyperbaric oxygen treatment

DEVICE

Contacts

Kun Wang Kun Wang, PhD

CONTACT

+8615989223200 gzwangkun@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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