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

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

Study Overview

• Status: Recruiting
• Conditions: Breast Cancers
• Intervention / Treatment: Device: hyperbaric oxygen treatment

• Study Type: Interventional
• Enrollment (Estimated): 161
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Kun Wang Kun Wang, PhD; Phone Number: +8615989223200; Email: gzwangkun@126.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Not yet recruiting
      • Guangdong Provincial People's Hospital
      • Contact: Kun Wang Kun Wang; Phone Number: 13922118086; Email: gzwangkun@126.com
    • Shantou, Guangdong, China, 515041
      • Recruiting
      • Guangdong Provincial People's Hospital
      • Contact: Kun Wang; Phone Number: 13922118086; Email: 19zyzhuang@stu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Understand the study process, participate in the study voluntarily, and sign the informed consent form.
2. 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
3. aged ≥ 18 years and ≤ 60 years, female
4. 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.)
5. ECOG performance status 0-1. 6.
6. LVEF ≥ 55% 7.
7. 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;

8. 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.

9. 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.

Exclusion Criteria:

1. 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).

2. previous hyperbaric oxygen therapy.
3. distant metastases, including lymph node metastases to the contralateral breast and mediastinum.

4. 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.

   Tumour.

5. pregnancy or lactation
6. uncontrolled hypertension, cardiac, hepatic, renal related disease or other medical or psychiatric conditions.
7. 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.
8. 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.
9. recent history of thromboembolism and taking full dose anticoagulant medication.
10. any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hyperbaric Oxygen group; 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).	Device: hyperbaric oxygen treatment; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Miller and payne classification		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.	After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)
RECIST criteria		After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)
life quality		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		during the hyperbaric oxygen therapy (up to half a year)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0		through study completion ( an average of half a year)
the Tumor immune microenvironment of the Hyperbaric Oxygen Therapy and neoadjuvant therapy		the time when the patient enrollment, at the end of the first cycle of neoadjuvant therapy (at about the first month), surgery

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital
• Investigators: Principal Investigator: Kun Wang, PhD, Guangdong Provincial People's Hospital Guangzhou,

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 21, 2025
• First Submitted That Met QC Criteria: February 1, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: KY2024-1081-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No