Enrolling by invitationNo phase
Hyperbaric oxygen therapy for breast cancer that has spread to the lungs
Tests hyperbaric oxygen alongside usual treatment in adults with breast cancer lung metastases.
Key facts
- Who runs it
- Jinan Central Hospital
- Where
- Jinan, ChinaSee the site
- Trial code
- Registry title
- Concept-verification Clinical Trial on the Inhibition of Breast Cancer Lung Metastasis Progression by Hyperbaric Oxygen
- Status
- Enrolling by invitation
- People taking part
- 10 people, planned
- Started
- 24 Nov 2025
- Expected to end
- 31 Dec 2026
- Type of study
- Interventional
- Treatments tested
- Hyperbaric Oxygen Therapy
- Record updated
- 7 April 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 18 to 75 with breast cancer that has spread to the lung and has grown after earlier treatment. It tests hyperbaric oxygen therapy added to standard treatment.
- Age
- 18 to 75 years
- Sex
- Women only
- Disease stage
- Invasive breast cancer with lung metastasis, with at least one measurable lung lesion of 10 mm or more that was not treated with radiotherapy before.
- Earlier treatment
- Disease grew after at least 1 line of systemic therapy that included chemotherapy for recurrent or metastatic disease.
Main reasons for not taking part
- Radiotherapy (other than palliative) or major surgery within 3 weeks before treatment
- Heart disease that is serious or not controlled, such as heart failure or a heart attack in the past 6 months
- Pregnant or breastfeeding
- Active hepatitis B or C infection with abnormal liver function
- Conditions that rule out hyperbaric oxygen, such as untreated pneumothorax, severe emphysema, or epilepsy with seizures in the past 2 years
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Active HBV or HCV infection (HBV DNA ≥500 IU/ml or positive HCV RNA) with abnormal liver function
- 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
- Presence of third-space fluid accumulation that cannot be controlled by drainage or other methods
- Currently pregnant or breastfeeding
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in China
- Jinan Central HospitalJinan, ChinaNo longer taking part
About the trial
What the trial wants to find out
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.
The group in the trial
- HBOIBCLMTreatment being tested
Patients in this arm will be treated with HBOT
Treatment: Hyperbaric Oxygen Therapy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Concept - Verification Clinical Trial on the Inhibition of Breast Cancer Lung Metastasis Progression by Hyperbaric Oxygen Therapy
- Plain-language title
- Hyperbaric oxygen therapy for breast cancer that has spread to the lungsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Fit questions
- Built from NCT07514728, who can take part
- Record updated
- 7 April 2026