Hyperbaric Oxygen in the Prevention of Radiation Pneumonitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Continuous Positive Airway Pressure Device or Deep Inspiration Breath Hold in Reducing Tumor Motion in Patients Undergoing Stereotactic Body Radiation Therapy for Lung Cancer

NCT03422302

Lung Carcinoma Malignant Respiratory Tract Neoplasm Metastatic Malignant Neoplasm in the Lung

RECRUITING NA

Active Breathing Coordinator-based vs VisionRT-based Deep Inspiration Breath-hold for Radiation for Breast Cancer

NCT02694029

Breast Cancer

COMPLETED NA

Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Centrally Located Early-stage Non-small Cell Lung Cancer

NCT06730295

Lung Cancer (NSCLC)

RECRUITING PHASE2

Thermal Ablation Combined With External Beam Radiation Therapy for Patients With Inoperable Non-Small Cell Lung Cancer > 3.5 cm in Size

NCT01028612

Non-small Cell Lung Cancer

TERMINATED NA

Prevention of Radiation Pneumonitis After Three-dimensional Conformal Radiation Therapy (3D-CRT) in Patients With Non-small-cell Lung Cancer

NCT00349102

Carcinoma, Non-small-cell Lung

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Radiotherapy is one of the important treatments to improve the survival rate of breast cancer patients. Radiotherapy also has the risk of radiation lung injury, which can develop into pulmonary fibrosis, which seriously affects the quality of life of patients. Hyperbaric oxygen has received more attention in the field of delayed tissue damage caused by radiotherapy. In a hyperbaric oxygen environment, sufficient oxygen supply can improve the tissue after radiation by promoting the function of vascular endothelial cells and fibroblasts, and reducing the secretion of inflammatory factors. Low blood vessel density, low cell activity and low oxygen content in the "three low" state, 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. Can hyperbaric oxygen therapy be applied for breast cancer patients who were receiving radiotherapy, reduce the risk of radiation pneumonitis, prevent radiation pneumonitis and even radiofibrosis, and improve long-term survival? Therefore, we plan to prospectively enroll 380 breast cancer patients and randomly divide them into two groups. The treatment group will be given 30-40 hyperbaric oxygen therapy immediately after the end of radiotherapy, to study whether hyperbaric oxygen therapy reduces the risk of radiation pneumonia, and to evaluate hyperbaric oxygen The safety of treatment and its impact on the patient's quality of life and long-term survival outcomes provide an effective means to reduce the incidence of radiation pneumonia and improve the long-term quality of life.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Radiation Pneumonitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

hyperbaric oxygen therapy group

30-40 times hyperbaric oxygen therapy

Group Type EXPERIMENTAL

hyperbaric oxygen therapy

Intervention Type BEHAVIORAL

hyperbaric oxygen therapy

control group

No hyperbaric oxygen therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

hyperbaric oxygen therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No