Hyperbaric Oxygen in the Prevention of Radiation Pneumonitis

ConditionRadiation Pneumonitis

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-70

SponsorGuangdong Provincial People's Hospital

About this trial

Radiotherapy is one of the important treatments to improve the survival rate of breast cancer patients, but also has the risk of radiation lung injury, which can develop into pulmonary fibrosis. Hyperbaric oxygen can improve the tissue after radiation by promoting the function of vascular endothelial cells and fibroblasts, and reducing the secretion of inflammatory factors, thereby inhibiting the process of fibrosis and fiber atrophy after radiotherapy, and promoting tissue repair. Therefore, it has the potential value of treating chronic radiation injury. We aim to investigate whether hyperbaric oxygen treatment can reduce the incidence of radiation pneumonia and improve patients' quality of life, and to evaluate its safety and the impact on the patients' long-term survival outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

(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.

Disqualifiers

(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).

Trial design

Design model

Single group

Treatments tested in this trial

hyperbaric oxygen therapy
Behavioral
hyperbaric oxygen therapy

Treatment groups

380 Participants

are divided into 2 treatment groups

Group A: hyperbaric oxygen therapy groupExperimental treatment 1 intervention

Group B: control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

Incidence of radiation pneumonitis

Rate of enrolled participants with radiation pneumonitis

Time frame

1 year

Secondary outcomes

Grade of symptoms related to radiation pneumonitis

The severity of symptoms (cough, shortness of breath, and so on) related to radiation pneumonitis, which is based on the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grading scale.

Time frame

1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangdong Provincial People's Hospital

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Collaborator

Source ClinicalTrials.gov

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