Breast CancersPhase 1/2NCT06811870
A Phase II Single-Arm Clinical Study to Explore the Efficacy and Safety of Hyperbaric Oxygen in the Neoadjuvant Treatment of Breast Cancer Patients
A Phase 1/2 study testing hyperbaric oxygen treatment in people with Breast Cancers, run by Guangdong Provincial People's Hospital at 2 sites in China.
Trial summary
The goal of the study is to explore the efficacy and safety of hyperbaric oxygen in the neoadjuvant treatment of breast cancer patients Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Breast Cancers
- What is being tested?
- hyperbaric oxygen treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 2 sitesChina
- Study dates
- 1 Feb 2025to 31 Dec 2026
- Phase
- Phase 1/2
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Understand the study process, participate in the study voluntarily, and sign the informed consent form.
- 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
- aged ≥ 18 years and ≤ 60 years, female
- patients who meet the inclusion criteria for neoadjuvant therapy to receive neoadjuvant therapy for breast cancer (locally advanced) Patients with locally advanced breast cancer (AJCC stage III, except T3N1M0) or operable breast cancer, but without breast-conserving or axillary preservation (stage IIA-IIB and T3N1M0) or HER2 positive or TNBC with certain tumour load, or patients with clinical lymph node positivity or tumour size of 2cm and above.)
- ECOG performance status 0-1. 6.
- LVEF ≥ 55% 7.
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- 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;
- 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.
- 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.
Who cannot join
- 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).
- previous hyperbaric oxygen therapy.
- distant metastases, including lymph node metastases to the contralateral breast and mediastinum.
- 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.
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- Tumour.
- pregnancy or lactation
- uncontrolled hypertension, cardiac, hepatic, renal related disease or other medical or psychiatric conditions.
- 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.
- serious or uncontrolled infections that may interfere with study treatment or assessment of study results, including but not limited to Serious or uncontrolled infections that may interfere with study treatment or the evaluation of study results, including but not limited to active hepatitis virus infection, human immunodeficiency virus (HIV) antibody positivity, and pulmonary infections.
- recent history of thromboembolism and taking full dose anticoagulant medication.
- any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Kun Wang Kun Wang, 13922118086, gzwangkun@126.com
- Recruiting
Guangdong Provincial People's Hospital
Shantou, Guangdong, 515041
Kun Wang, 13922118086, 19zyzhuang@stu.edu.cn
About this study
The goal of the study is to explore the efficacy and safety of hyperbaric oxygen in the neoadjuvant treatment of breast cancer patients
- Conditions
- Breast Cancers
- Being tested
- hyperbaric oxygen treatment
- 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 treatmentDevice
Patients who meet the inclusion criteria will be enrolled and given hyperbaric oxygen intervention, with a minimum of 5 hyperbaric oxygen treatments per chemotherapy cycle, one per day for 60-90 minutes, for a total of 30-40 hyperbaric oxygen treatments (100% oxygen at a pressure of 2.0 ATA).
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric Oxygen group | Experimental | Patients who meet the inclusion criteria will be enrolled and given hyperbaric oxygen intervention, with a minimum of 5 times hyperbaric oxygen treatments per chemotherapy cycle, one per day for 60-90 minutes, for a total of 30-40 hyperbaric oxygen treatments (100% oxygen at a pressure of 2.0 ATA). Receives: Device: hyperbaric oxygen treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR rate after hyperbaric oxygen combined with neoadjuvant therapy in breast cancer patients
pCR rate after hyperbaric oxygen combined with neoadjuvant therapy in breast cancer patients
Measured: After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)
Secondary outcomes (7)
The Miller and payne classification
Measured: After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)
RCB 0/1 rate
RCB (Residual Cancer Burden) is a commonly used metric to assess the extent of residual tumor burden after neoadjuvant therapy, such as chemotherapy, radiation therapy, or targeted therapy.
RCB 0: Complete response (CR) - No visible residual tumor, complete disappearance of the tumor.
RCB I: Minimal residual disease - Only a small amount of residual tumor remains, with limited tumor volume and few lymph node metastases.
RCB II: Moderate residual disease - Moderate degree of tumor residual is present.
RCB III: Extensive residual disease - A large amount of residual tumor remains, often with more lymph node metastases.
Measured: After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)
RECIST criteria
Measured: After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)
life quality
Measured: At the time of patient enrolment, Each cycle of chemotherapy (8cycle, each cycle is 3 weeks), Day before surgery, 3 months after surgery.
Side effects of hyperbaric oxygen therapy
Measured: during the hyperbaric oxygen therapy (up to half a year)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: through study completion ( an average of half a year)
the Tumor immune microenvironment of the Hyperbaric Oxygen Therapy and neoadjuvant therapy
Measured: the time when the patient enrollment, at the end of the first cycle of neoadjuvant therapy (at about the first month), surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start1 Feb 2025
- Primary completion31 Dec 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 CancersStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 161 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kun Wang, Guangdong Provincial People's Hospital
- Investigators
- Kun Wang, PhD, Principal investigator, Guangdong Provincial People's Hospital Guangzhou,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811870
- Sponsor's protocol ID
- KY2024-1081-03
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2025
- Last updated
- 1 Apr 2025
- 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 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Single-Arm Clinical Study to Explore the Efficacy and Safety of Hyperbaric Oxygen in the Neoadjuvant Treatment of Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06811870
- Acronym / sponsor ID
- KY2024-1081-03
- Conditions
- Breast Cancers
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 161 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Feb 2025 (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.
The goal of the study is to explore the efficacy and safety of hyperbaric oxygen in the neoadjuvant treatment of breast cancer patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric Oxygen group | Experimental | Device: hyperbaric oxygen treatmentPatients who meet the inclusion criteria will be enrolled and given hyperbaric oxygen intervention, with a minimum of 5 times hyperbaric oxygen treatments per chemotherapy cycle, one per day for 60-90 minutes, for a total of 30-40 hyperbaric oxygen treatments (100% oxygen at a pressure of 2.0 ATA). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Understand the study process, participate in the study voluntarily, and sign the informed consent form.
- 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
- aged ≥ 18 years and ≤ 60 years, female
- patients who meet the inclusion criteria for neoadjuvant therapy to receive neoadjuvant therapy for breast cancer (locally advanced) Patients with locally advanced breast cancer (AJCC stage III, except T3N1M0) or operable breast cancer, but without breast-conserving or axillary preservation (stage IIA-IIB and T3N1M0) or HER2 positive or TNBC with certain tumour load, or patients with clinical lymph node positivity or tumour size of 2cm and above.)
- ECOG performance status 0-1. 6.
Key exclusion criteria (13 listed)
- 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).
- previous hyperbaric oxygen therapy.
- distant metastases, including lymph node metastases to the contralateral breast and mediastinum.
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 treatmentPatients who meet the inclusion criteria will be enrolled and given hyperbaric oxygen intervention, with a minimum of 5 hyperbaric oxygen treatments per chemotherapy cycle, one per day for 60-90 minutes, for a total of 30-40 hyperbaric oxygen treatments (100% oxygen at a pressure of 2.0 ATA). | Device | Hyperbaric Oxygen group |
Primary outcome
pCR rate after hyperbaric oxygen combined with neoadjuvant therapy in breast cancer patients
Time frame: After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)
pCR rate after hyperbaric oxygen combined with neoadjuvant therapy in breast cancer patients
7 secondary outcomes
The Miller and payne classification
Time frame: After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)
RCB 0/1 rate
Time frame: After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)
RECIST criteria
Time frame: After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)
life quality
Time frame: At the time of patient enrolment, Each cycle of chemotherapy (8cycle, each cycle is 3 weeks), Day before surgery, 3 months after surgery.
Side effects of hyperbaric oxygen therapy
Time frame: during the hyperbaric oxygen therapy (up to half a year)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: through study completion ( an average of half a year)
the Tumor immune microenvironment of the Hyperbaric Oxygen Therapy and neoadjuvant therapy
Time frame: the time when the patient enrollment, at the end of the first cycle of neoadjuvant therapy (at about the first month), surgery
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 1 Apr 2025.
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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.
Kun Wang, PhD principal investigator
Guangdong Provincial People's Hospital Guangzhou,
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing hyperbaric oxygen treatment in people with Breast Cancers, run by Guangdong Provincial People's Hospital at 2 sites 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 11 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Kun Wang Kun Wang, PhD (+8615989223200, gzwangkun@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR rate after hyperbaric oxygen combined with neoadjuvant therapy in breast cancer patients (time frame: After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)). 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 1 Apr 2025.