Concept-verification Clinical Trial on the Inhibition of Breast Cancer Lung Metastasis Progression by Hyperbaric Oxygen

Enrolling by invitation · Not applicable

Conditions studied: Breast Cancer, Lung Metastasis, Hyperbaric Oxygen Therapy

In brief

This is a proof-of-concept clinical trial focused on exploring whether hyperbaric oxygen therapy (HBOT) can inhibit the progression of lung metastasis in breast cancer patients. Patients enrolled in this arm will receive standard breast cancer treatment combined with HBOT.

Key facts

Study ID

NCT07514728

Run by

Jinan Central Hospital

People needed

10

Starts

2025-11-24

Expected to finish

2026-12-31

Last updated by the study team

2026-04-07

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Aged 18-75 years, female;
• Histologically confirmed invasive breast cancer with lung metastasis (diagnosed via contrast-enhanced chest CT, PET-CT, or MRI);
• Disease progression after at least 1 line of systemic therapy containing chemotherapy for recurrent/metastatic disease (per RECIST 1.1 criteria);
• At least one measurable lung metastatic lesion (≥10 mm on spiral CT/MRI, not previously treated with radiotherapy) per RECIST 1.1;
• Adequate organ function (e.g., hemoglobin ≥90 g/L, alanine transaminase/aspartate transaminase ≤3× upper limit of normal [ULN], serum creatinine ≤1× ULN, no severe arrhythmia or myocardial ischemia on ECG);
• ECOG performance status ≤2 and life expectancy ≥3 months;
• Use of medically approved contraception (for women of childbearing potential) during treatment and for at least 3 months after the last treatment;
• Voluntary participation, signed informed consent, and willingness to comply with treatment and follow-up.

You may not qualify if…

• Received radiotherapy (excluding palliative radiotherapy) within 3 weeks prior to treatment; received major surgery (excluding minor outpatient procedures such as vascular access placement) within 3 weeks before the first cycle of study treatment;
• Persistent grade ≥2 adverse events from prior treatments (e.g., chemotherapy, surgery) (except alopecia or conditions the investigator deems should not result in exclusion);
• History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina pectoris, myocardial infarction within the past 6 months, or ventricular arrhythmias;
• Presence of third-space fluid accumulation that cannot be controlled by drainage or other methods;
• Active HBV or HCV infection (HBV DNA ≥500 IU/ml or positive HCV RNA) with abnormal liver function;
• Currently pregnant or breastfeeding;
• Allergic diathesis, or known history of allergy to components of the conventional treatment medications in this study, or to HBOT-related equipment/gas components (e.g., pure oxygen);
• Presence of contraindications to HBOT, such as untreated pneumothorax, pulmonary bullae, severe emphysema, history of epilepsy (with seizures within the past 2 years), or acute exacerbation of severe sinusitis/otitis media.

Where it is running

• Jinan Central Hospital — Jinan, Shandong, China

Full record on ClinicalTrials.gov

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