Actively Recruiting
Study on the Effectiveness and Safety of Hyperbaric Oxygen Therapy for Preventing Radiation Pneumonitis Caused by Radiotherapy and Chemotherapy of Breast Cancer
Led by Guangdong Provincial People's Hospital · Updated on 2025-02-12
380
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
G
Guangdong Provincial People's Hospital
Lead Sponsor
F
First Affiliated Hospital, Sun Yat-Sen University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether hyperbaric oxygen therapy can reduce the risk of radiation pneumonitis and improve quality of life in breast cancer patients who have undergone radiotherapy. Radiotherapy is an important treatment to increase survival but can cause lung injury and pulmonary fibrosis, affecting patients' health. This study aims to assess the safety and long-term survival impact of hyperbaric oxygen treatment in this setting. The study randomly divides 380 breast cancer patients into two groups. One group receives 30 to 40 sessions of hyperbaric oxygen therapy immediately after finishing radiotherapy, while the other group does not receive this treatment. Researchers will compare the incidence of radiation pneumonitis and evaluate symptom severity, safety, and quality of life outcomes between the groups. Participants will be monitored over a one-year period to track the occurrence and severity of radiation pneumonitis using clinical assessments and imaging. Quality of life and long-term survival outcomes will also be evaluated. The study includes regular follow-ups to assess safety and treatment effects, providing important data on whether hyperbaric oxygen therapy can help protect lung tissue after radiotherapy in breast cancer patients.
CONDITIONS
Brief Title
Hyperbaric Oxygen in the Prevention of Radiation Pneumonitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteer to participate and sign informed consent in writing
- Past pathological diagnosis of breast cancer with radical treatment or surgery
- Completed adjuvant chemotherapy followed by radiotherapy
- No simple neck lymph node recurrence or distant metastases
- No secondary malignant tumor in other parts
- Age between 18 and 70 years, male or female
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Expected survival period of at least 2 years
- No acute radiation lung injury on chest CT before and after radiotherapy
You will not qualify if you...
- Contraindications to hyperbaric oxygen therapy such as severe chronic obstructive airway disease, bullous lung disease, acute or chronic lung infection, uncontrolled asthma, untreated pneumothorax
- History of ear surgery, middle ear disease, or eye disease like retinal detachment
- Previous hyperbaric oxygen therapy
- Existing radiation pneumonia at enrollment or before hyperbaric oxygen therapy
- Women who are pregnant or breastfeeding
- Incomplete comprehensive breast cancer treatment due to disease progression, side effects, or treatment abandonment
- Need for mechanical ventilation support
- Inability to follow or understand simple commands
- Disorientation or mental disorders
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of 30 to 40 therapy sessions following radiotherapy
Participants in the treatment group receive 30 to 40 sessions of hyperbaric oxygen therapy immediately after completing radiotherapy. Participants in the control group do not receive hyperbaric oxygen therapy.
30 to 40 visits (in-person)
Duration - Up to 1 year
Participants are monitored for up to 1 year after treatment to assess the incidence and severity of radiation pneumonitis and to evaluate safety and quality of life.
Regular follow-up visits during the year
Trial Site Locations
Total: 1 location
1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Actively Recruiting
Research Team
K
Kun Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
2
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