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A Phase II Single-Arm Clinical Study to Explore the Efficacy and Safety of Hyperbaric Oxygen in the Neoadjuvant Treatment of Breast Cancer Patients

ConditionBreast Cancers
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorGuangdong Provincial People's Hospital

About this trial

The goal of the study is to explore the efficacy and safety of hyperbaric oxygen in the neoadjuvant treatment of breast cancer patients

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.)

Disqualifiers

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).

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • hyperbaric oxygen treatment

    Device

    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).

Treatment groups

161 Participants
are divided into 1 treatment group
Group A: Hyperbaric Oxygen groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)

Secondary outcomes

1

The Miller and payne classification

Time frame
After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)
2

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.

Time frame
After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)
3

RECIST criteria

Time frame
After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)
4

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangdong Provincial People's Hospital

Lead sponsor

Source ClinicalTrials.gov
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