RecruitingPhase 1Phase 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


Sponsor

Guangdong Provincial People's Hospital

Enrollment

161 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring whether hyperbaric oxygen therapy — breathing pure oxygen in a pressurized chamber — can improve outcomes when added to standard neoadjuvant (pre-surgery) chemotherapy for breast cancer. **You may be eligible if...** - You are a woman between 18 and 60 years old - You have been newly diagnosed with invasive breast cancer (not inflammatory or eczema-type) - Your cancer is locally advanced (AJCC stage III, excluding T3N1M0) or operable but not suited for breast-conserving surgery - You are already recommended for neoadjuvant chemotherapy before surgery **You may NOT be eligible if...** - You have inflammatory breast cancer or eczema-like (Paget's) breast cancer - You are not a candidate for neoadjuvant chemotherapy - You have conditions that make hyperbaric oxygen unsafe (such as certain lung or ear conditions) - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEhyperbaric 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).


Locations(2)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Guangdong Provincial People's Hospital

Shantou, Guangdong, China

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NCT06811870


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