Using hyperbaric oxygen to prevent lung damage from breast cancer radiation therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Guangdong Provincial People's Hospital
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Kun Wang
• Email: gzwangkun@126.com
• Phone: 13922118086

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.