Breast CancerHBOIBCLMNCT07514728
Concept-verification Clinical Trial on the Inhibition of Breast Cancer Lung Metastasis Progression by Hyperbaric Oxygen
A study testing Hyperbaric Oxygen Therapy in people with Breast Cancer and Lung Metastasis, run by Jinan Central Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Lung Metastasis, Hyperbaric Oxygen Therapy
- What is being tested?
- Hyperbaric Oxygen Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 24 Nov 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Concept - Verification Clinical Trial on the Inhibition of Breast Cancer Lung Metastasis Progression by Hyperbaric Oxygen Therapy
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.
Read the detailed description
Breast cancer is prone to distant metastasis, with the lungs being one of the most common target sites. Tumor hypoxia (a low-oxygen microenvironment) is a key factor promoting tumor progression and metastasis, and it can also reduce the efficacy of conventional treatments. HBOT delivers 100% oxygen at a pressure of 2.0-2.5 atmospheres absolute, which effectively improves tissue oxygenation, modifies the tumor microenvironment, and may suppress tumor growth by inhibiting cell migration and invasion and inducing tumor cell death.
This study aims to verify the potential of HBOT as an adjuvant therapy to slow or block breast cancer lung metastasis progression. Eligible participants (aged 18-75 years with pathologically confirmed breast cancer accompanied by lung metastasis and no prior HBOT contraindications) will receive standard breast cancer treatment (including surgery, chemotherapy, radiotherapy, or targeted therapy as appropriate) combined with HBOT. The HBOT regimen will consist of 6 sessions per week for 2 consecutive weeks, with each session lasting 120 minutes, including 15 minutes for increasing pressure and 15 minutes for reducing pressure, at 2.5 ATA and 100% oxygen. Over a 6-month follow-up period, participants will undergo regular assessments including chest CT (to monitor lung metastasis lesions), serum tumor marker tests, and quality of life evaluations. The primary outcome is the objective response rate (ORR) of tumors evaluated according to the RECIST version 1.1 criteria: the proportion of subjects with complete response (CR) + partial response (PR), and secondary outcomes include changes in progression-free survival, the number and viability of circulating tumor cells and safety indicators.
Participants may benefit from potential inhibition of lung metastasis progression and access to a well-tolerated adjuvant therapy. HBOT-related side effects are usually mild and temporary, such as ear discomfort or pressure changes, which will be closely monitored and managed by the study team throughout the treatment process.
This research is significant as it explores a clinically available, safe therapy for addressing breast cancer lung metastasis-a major challenge affecting patient prognosis. If proven effective, HBOT could become an important part of comprehensive breast cancer treatment, helping to improve patient outcomes and quality of life.
- Conditions
- Breast Cancer, Lung Metastasis, Hyperbaric Oxygen Therapy
- Being tested
- Hyperbaric Oxygen Therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen TherapyDevice
Also called Hyperbaric Oxygen Therapy (2.5 ATA and 100% oxygen)
The HBOT regimen will consist of 6 sessions per week for 2 consecutive weeks, with each session lasting 90 minutes at 2.5 ATA and 100% oxygen.
| Study group | Role | What they receive |
|---|---|---|
| HBOIBCLM | Experimental | Patients in this arm will be treated with HBOT Receives: Device: Hyperbaric Oxygen Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
The objective response rate (ORR) of lung metastatic tumors as assessed according to the RECIST 1.1 standard: the proportion of subjects who achieved complete response (CR) or partial response (PR).
Measured: From the time of registration to 6 weeks after the end of treatment (that is, at 8 weeks)
Secondary outcomes (4)
Disease Control Rate (DCR)
Disease Control Rate (DCR): The proportion of subjects who achieved Complete Response (CR), Partial Response (PR), or Stable Disease (SD)
Measured: Up to 24 weeks
Progression-Free Survival
Progression-Free Survival
Measured: The period of time from the date of patient enrollment until any recorded tumor progression or death due to any cause. Up to 52 weeks
CTC Number and Viability
Number and viability changes of circulating tumor cell in blood samples between before and after treatment
Measured: From enrollment to the end of treatment at 2 weeks
Adverse Events
The incidence, severity and outcome of adverse events during treatment will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE v5.0) of the National Cancer Institute of the United States.
Measured: From enrollment to the end of the trial. Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start24 Nov 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinan Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514728
- Sponsor's protocol ID
- JinanCH
- Acronym
- HBOIBCLM
- Status last verified
- Jan 2026
- First submitted
- 19 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concept - Verification Clinical Trial on the Inhibition of Breast Cancer Lung Metastasis Progression by Hyperbaric Oxygen Therapy
- ClinicalTrials.gov ID
- NCT07514728
- Acronym / sponsor ID
- HBOIBCLM / JinanCH
- Conditions
- Breast Cancer, Lung Metastasis, Hyperbaric Oxygen Therapy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Jinan Central HospitalUniversity, hospital or other
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Breast cancer is prone to distant metastasis, with the lungs being one of the most common target sites. Tumor hypoxia (a low-oxygen microenvironment) is a key factor promoting tumor progression and metastasis, and it can also reduce the efficacy of conventional treatments. HBOT delivers 100% oxygen at a pressure of 2.0-2.5 atmospheres absolute, which effectively improves tissue oxygenation, modifies the tumor microenvironment, and may suppress tumor growth by inhibiting cell migration and invasion and inducing tumor cell death.
This study aims to verify the potential of HBOT as an adjuvant therapy to slow or block breast cancer lung metastasis progression. Eligible participants (aged 18-75 years with pathologically confirmed breast cancer accompanied by lung metastasis and no prior HBOT contraindications) will receive standard breast cancer treatment (including surgery, chemotherapy, radiotherapy, or targeted therapy as appropriate) combined with HBOT. The HBOT regimen will consist of 6 sessions per week for 2 consecutive weeks, with each session lasting 120 minutes, including 15 minutes for increasing pressure and 15 minutes for reducing pressure, at 2.5 ATA and 100% oxygen. Over a 6-month follow-up period, participants will undergo regular assessments including chest CT (to monitor lung metastasis lesions), serum tumor marker tests, and quality of life evaluations. The primary outcome is the objective response rate (ORR) of tumors evaluated according to the RECIST version 1.1 criteria: the proportion of subjects with complete response (CR) + partial response (PR), and secondary outcomes include changes in progression-free survival, the number and viability of circulating tumor cells and safety indicators.
Participants may benefit from potential inhibition of lung metastasis progression and access to a well-tolerated adjuvant therapy. HBOT-related side effects are usually mild and temporary, such as ear discomfort or pressure changes, which will be closely monitored and managed by the study team throughout the treatment process.
This research is significant as it explores a clinically available, safe therapy for addressing breast cancer lung metastasis-a major challenge affecting patient prognosis. If proven effective, HBOT could become an important part of comprehensive breast cancer treatment, helping to improve patient outcomes and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HBOIBCLM | Experimental | Device: Hyperbaric Oxygen TherapyPatients in this arm will be treated with HBOT |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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);
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric Oxygen TherapyAlso: Hyperbaric Oxygen Therapy (2.5 ATA and 100% oxygen)The HBOT regimen will consist of 6 sessions per week for 2 consecutive weeks, with each session lasting 90 minutes at 2.5 ATA and 100% oxygen. | Device | HBOIBCLM |
Primary outcome
Objective Response Rate
Time frame: From the time of registration to 6 weeks after the end of treatment (that is, at 8 weeks)
The objective response rate (ORR) of lung metastatic tumors as assessed according to the RECIST 1.1 standard: the proportion of subjects who achieved complete response (CR) or partial response (PR).
4 secondary outcomes
Disease Control Rate (DCR)
Time frame: Up to 24 weeks
Progression-Free Survival
Time frame: The period of time from the date of patient enrollment until any recorded tumor progression or death due to any cause. Up to 52 weeks
CTC Number and Viability
Time frame: From enrollment to the end of treatment at 2 weeks
Adverse Events
Time frame: From enrollment to the end of the trial. Up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric Oxygen Therapy in people with Breast Cancer and Lung Metastasis, run by Jinan Central Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: From the time of registration to 6 weeks after the end of treatment (that is, at 8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.