Actively Recruiting
A Phase II Single-Arm Clinical Study to Explore the Efficacy and Safety of Hyperbaric Oxygen in the Neoadjuvant Treatment of Breast Cancer Patients
Led by Guangdong Provincial People's Hospital · Updated on 2025-04-01
161
Participants Needed
2
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of the study is to explore the efficacy and safety of hyperbaric oxygen in the neoadjuvant treatment of breast cancer patients
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 60 years
- Diagnosed with initial unilateral primary invasive breast cancer excluding occult, inflammatory, or eczema-like carcinoma
- Eligible for neoadjuvant therapy for locally advanced or certain operable breast cancer stages
- ECOG performance status of 0 or 1
- Left ventricular ejection fraction (LVEF) of 55% or higher
- Adequate bone marrow function with specified blood count thresholds
- Liver enzymes (AST, ALT) and alkaline phosphatase not exceeding 2.5 times the upper normal limit
- Total bilirubin and serum creatinine within 1.5 times the upper normal limit
- For non-menopausal or non-sterilized women, agreement to use contraception during and for at least 7 months after treatment
- Voluntary participation with informed consent
You will not qualify if you...
- Contraindications to hyperbaric oxygen therapy, including untreated pneumothorax, concurrent use of disulfiram, or certain anti-tumor drugs
- History of middle ear surgery or middle ear disease
- Previous hyperbaric oxygen therapy
- Presence of distant metastases
- Other malignancies within the past two years except certain treated skin or cervical cancers
- Pregnancy or lactation
- Uncontrolled hypertension or significant cardiac, liver, kidney, or psychiatric diseases
- Major surgery unrelated to breast cancer within 4 weeks before enrollment or incomplete recovery
- Serious or uncontrolled infections including active hepatitis, HIV positivity, or pulmonary infections
- Recent thromboembolism requiring full-dose anticoagulants
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Not Yet Recruiting
2
Guangdong Provincial People's Hospital
Shantou, Guangdong, China, 515041
Actively Recruiting
Research Team
K
Kun Wang Kun Wang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here