Using hyperbaric oxygen to prevent lung damage from breast cancer radiation therapy
Study on the Effectiveness and Safety of Hyperbaric Oxygen Therapy for Preventing Radiation Pneumonitis Caused by Radiotherapy and Chemotherapy of Breast Cancer
This study is testing if hyperbaric oxygen therapy can help prevent lung damage in breast cancer patients receiving radiation treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 380 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Guangdong Provincial People's Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05189496 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of hyperbaric oxygen therapy to reduce the incidence of radiation pneumonitis in breast cancer patients undergoing radiotherapy. It aims to enroll 380 participants who will be randomly assigned to receive either hyperbaric oxygen therapy or standard care after their radiotherapy treatment. The study will evaluate the safety of the therapy and its potential to improve patients' quality of life and long-term survival outcomes by promoting tissue repair and reducing inflammation. The approach focuses on enhancing vascular function and reducing fibrosis associated with radiation injury.
Who should consider this trial
Good fit: Ideal candidates are breast cancer patients aged 18 to 70 who have undergone radical treatment and are receiving adjuvant chemotherapy followed by radiotherapy.
Not a fit: Patients with severe lung diseases or those who have experienced acute radiation lung injury may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of radiation pneumonitis and improve the quality of life for breast cancer patients.
How similar studies have performed: While hyperbaric oxygen therapy has shown promise in treating radiation injuries in other contexts, this specific application in breast cancer patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * (1) Volunteer to participate and sign informed consent in writing. (2) Past pathological diagnosis of breast cancer followed by radical treatment/surgery for breast cancer, followed by adjuvant chemotherapy followed by radiotherapy. (3) Excluding patients with simple neck lymph node recurrence and patients with distant metastases. (4) There is no secondary malignant tumor in other parts. (5) Age at entry ≥ 18 years old and ≤ 70 years old, both male and female. (6) The Eastern Cooperative Oncology Group (ECOG) has a performance status score of 0 or 1. (7) The expected survival period is ≥2 years. (8) There was no acute radiation lung injury in chest CT examination before and after radiotherapy Exclusion Criteria: * (1) Contraindications to hyperbaric oxygen therapy: lung disease (severe chronic obstructive airway disease, bullous lung disease, acute or chronic lung infection, uncontrolled asthma, untreated pneumothorax), in the past History of ear surgery, middle ear disease (eustachian tube dysfunction, recurrent dizziness), eye disease (retinal detachment). (2) Have received hyperbaric oxygen therapy in the past. (3) Radiation pneumonia had occurred at the time of enrollment or before receiving hyperbaric oxygen therapy. (4) Women who are pregnant or breastfeeding. (5) Patients who have not completed comprehensive breast cancer treatment due to disease progression, intolerable side effects, abandonment of treatment and other reasons. (8) Patients who need mechanical ventilation support. (9) Patients who cannot follow and understand simple commands. (10) Patients with disorientation and mental disorders.
Where this trial is running
Guangzhou, Guangdong
- Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Kun Wang
- Email: gzwangkun@126.com
- Phone: 13922118086
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.