What is hyperbaric oxygen therapy studying for breast cancer?

Hyperbaric oxygen therapy is being studied as part of the pre-surgery treatment for breast cancer to see how it works alongside chemotherapy. Researchers want to find out if adding this therapy can improve treatment outcomes and safety. The study is sponsored by Guangdong Provincial People's Hospital to explore new options for breast cancer care.

Who may be eligible for this breast cancer clinical trial?

Women aged 18 to 60 with confirmed unilateral invasive breast cancer, who are candidates for neoadjuvant chemotherapy, may be eligible. Participants must have good heart and bone marrow function and be able to consent voluntarily. Please review eligibility criteria for more details.

Is there any cost to participate in this breast cancer clinical trial?

Study-related care, including the study treatment and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years - 60Years

FEMALE

ID06811870

Phase II Study of Hyperbaric Oxygen Therapy Combined with Neoadjuvant Treatment for Breast Cancer in Women Aged 18 to 60

Led by Guangdong Provincial People's Hospital · Updated on 2025-04-01

161

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of hyperbaric oxygen therapy as a part of neoadjuvant treatment for women with breast cancer. This Phase II single-arm clinical study aims to explore how well hyperbaric oxygen works alongside standard chemotherapy before surgery, focusing on patients with specific types of invasive breast cancer. The study is sponsored by Guangdong Provincial Peoples Hospital and seeks to improve treatment outcomes for breast cancer patients. Participants will receive hyperbaric oxygen treatments at a pressure of 2.0 ATA with 100% oxygen for 60 to 90 minutes per session. Treatments are given at least five times during each chemotherapy cycle, totaling between 30 and 40 sessions over the course of the study. This intervention is combined with standard neoadjuvant chemotherapy cycles, each lasting three weeks, with up to eight cycles. During the study, participants will undergo assessments including tumor response evaluations using pathological complete response rates, imaging criteria, and tumor immune environment analysis. Quality of life will be measured at enrollment, before surgery, and three months after surgery. Side effects and treatment-related adverse events will be monitored throughout the therapy and for up to six months. The total participation duration spans approximately half a year, covering treatment and follow-up periods.

CONDITIONS

Brief 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

Who Can Participate

Age: 18Years - 60Years

FEMALE

Eligibility Criteria

You may qualify if you...

Understand the study process, participate voluntarily, and sign informed consent.
Female patients aged 18 to 60 years.
Histopathologically confirmed initial unilateral primary invasive breast cancer, excluding occult, inflammatory breast cancer, and eczema-like carcinoma.
Eligible for neoadjuvant therapy: locally advanced breast cancer (AJCC stage III except T3N1M0), operable breast cancer without breast-conserving or axillary preservation (stage IIA-IIB and T3N1M0), HER2 positive or triple-negative breast cancer with certain tumor load, clinical lymph node positivity, or tumor size 2cm and above.
ECOG performance status 0-1.
Left ventricular ejection fraction (LVEF) ≥ 55%.
Adequate bone marrow function: WBC ≥ 3.0 x 10^9/L, neutrophils ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, hemoglobin ≥ 90 g/L.
Liver and kidney function within specified limits: AST, ALT ≤ 2.5 times upper limit, alkaline phosphatase ≤ 2.5 times upper limit, total bilirubin ≤ 1.5 times upper limit, serum creatinine ≤ 1.5 times upper limit.
For non-menopausal or non-surgically sterilized women: agree to use contraception during treatment and for at least 7 months after last dose.

You will not qualify if you...

Contraindications to hyperbaric oxygen therapy including untreated pneumothorax, concurrent use of disulfiram, certain chemotherapy drugs (bleomycin, cisplatin, adriamycin), premature or low birth weight neonates, severe lung diseases (COPD, herpetic lung disease, infections, uncontrolled asthma or diarrhea), middle ear or ocular diseases.
Previous hyperbaric oxygen therapy.
Distant metastases including contralateral breast or mediastinal lymph nodes.
Other malignant tumors within last two years except certain skin or cervical carcinomas.
Pregnancy or breastfeeding.
Uncontrolled hypertension, heart, liver, kidney diseases, or psychiatric conditions.
Recent major surgery unrelated to breast cancer within 4 weeks or not fully recovered.
Serious or uncontrolled infections including active hepatitis, HIV positivity, pulmonary infections.
Recent thromboembolism requiring full-dose anticoagulation.
Any condition judged by the investigator to make participation unsuitable.

Research Team

Kun Wang Kun Wang, PhD

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Phase II Study of Hyperbaric Oxygen Therapy Combined with Neoadjuvant Treatment for Breast Cancer in Women Aged 18 to 60

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria