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

Plain English Summary

Concept-verification Clinical Trial on the Inhibition of Breast Cancer Lung Metastasis Progression by Hyperbaric Oxygen is a Not Applicable clinical trial sponsored by Jinan Central Hospital studying Breast Cancer, Lung Metastasis, Hyperbaric Oxygen Therapy. This trial tests if breathing pure oxygen under pressure (hyperbaric oxygen therapy) can help stop breast cancer from spreading to the lungs. It is for women with breast cancer that has already spread to the lungs and has not responded well to previous chemotherapy. Participants will receive standard breast cancer treatment along with hyperbaric oxygen therapy. There are no specific alternative treatments mentioned for comparison within this trial. The trial aims to enroll 10 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Women aged 18-75 with breast cancer that has spread to the lungs. Must have had at least one previous chemotherapy treatment for the spread. Cannot have certain heart conditions, uncontrolled infections, or be pregnant/breastfeeding. Cannot have had radiation to the lungs or major surgery recently, and must not have conditions that prevent hyperbaric oxygen therapy (like untreated pneumothorax or recent seizures). This trial is studying Breast Cancer, Lung Metastasis, Hyperbaric Oxygen Therapy, so participants generally need a confirmed diagnosis.

What They're Measuring

The main goal is to see how many patients respond to the treatment by shrinking or stopping the growth of lung tumors, which could mean the therapy is effective. The specific primary outcome measures are: Objective Response Rate (From the time of registration to 6 weeks after the end of treatment (that is, at 8 weeks)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial matters because it explores a new way to potentially stop breast cancer from spreading to the lungs, a common and serious challenge for patients. This research targets Breast Cancer, Lung Metastasis, Hyperbaric Oxygen Therapy, where improved treatment options are needed.

Investor Insight

This early-stage trial signals interest in novel approaches for metastatic breast cancer, a large market, with hyperbaric oxygen therapy representing a potentially competitive, non-chemotherapy option

Is This Trial Right for Me?

Ask your doctor if this therapy is right for you, considering your specific cancer and health. Participation involves receiving standard breast cancer treatments and daily sessions of breathing pure oxygen in a special chamber for two weeks. You will need to attend regular appointments for treatment and monitoring of your condition and any side effects. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 10 participants

Interventions

• DEVICE: Hyperbaric Oxygen Therapy — 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.

Primary Outcomes

• Objective Response Rate (From the time of registration to 6 weeks after the end of treatment (that is, at 8 weeks))

Secondary Outcomes

• Disease Control Rate (DCR) (Up to 24 weeks)
• Progression-Free Survival (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 (From enrollment to the end of treatment at 2 weeks)
• Adverse Events (From enrollment to the end of the trial. Up to 24 weeks)

Full Eligibility Criteria

Inclusion Criteria:

1. Aged 18-75 years, female;
2. Histologically confirmed invasive breast cancer with lung metastasis (diagnosed via contrast-enhanced chest CT, PET-CT, or MRI);
3. Disease progression after at least 1 line of systemic therapy containing chemotherapy for recurrent/metastatic disease (per RECIST 1.1 criteria);
4. At least one measurable lung metastatic lesion (≥10 mm on spiral CT/MRI, not previously treated with radiotherapy) per RECIST 1.1;
5. 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);
6. ECOG performance status ≤2 and life expectancy ≥3 months;
7. Use of medically approved contraception (for women of childbearing potential) during treatment and for at least 3 months after the last treatment;
8. Voluntary participation, signed informed consent, and willingness to comply with treatment and follow-up.

Exclusion Criteria:

1. 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;
2. Persistent grade ≥2 adverse events from prior treatments (e.g., chemotherapy, surgery) (except alopecia or conditions the investigator deems should not result in exclusion);
3. History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina pectoris, myocardial infarction within the past 6 months, or ventricular arrhythmias;
4. Presence of third-space fluid accumulation that cannot be controlled by drainage or other methods;
5. Active HBV or HCV infection (HBV DNA ≥500 IU/ml or positive HCV RNA) with abnormal liver function;
6. Currently pregnant or breastfeeding;
7. 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);
8. 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

• Jinan Central Hospital, Jinan, Shandong, China

Frequently Asked Questions

Related Conditions

• Breast Cancer
• Lung Metastasis
• Metastatic Breast Cancer
• Triple-Negative Breast Cancer
• Hormone Receptor-Positive Breast Cancer
• HER2-Positive Breast Cancer
• Oncology
• Cancer Therapy
• Oxygen Therapy
• Hyperbaric Medicine

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