Radiation PneumonitisNCT05189496
Hyperbaric Oxygen in the Prevention of Radiation Pneumonitis
A study testing hyperbaric oxygen therapy in people with Radiation Pneumonitis, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Radiation Pneumonitis
- What is being tested?
- hyperbaric oxygen therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
- Excluding patients with simple neck lymph node recurrence and patients with distant metastases.
- 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.
- The expected survival period is ≥2 years. (8) There was no acute radiation lung injury in chest CT examination before and after radiotherapy
Who cannot join
- (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).
- Have received hyperbaric oxygen therapy in the past. (3) Radiation pneumonia had occurred at the time of enrollment or before receiving hyperbaric oxygen therapy.
- 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.
- Patients who need mechanical ventilation support. (9) Patients who cannot follow and understand simple commands. (10) Patients with disorientation and mental disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Kun Wang, 13922118086, gawangkun@126.com
About this study
Official title: Study on the Effectiveness and Safety of Hyperbaric Oxygen Therapy for Preventing Radiation Pneumonitis Caused by Radiotherapy and Chemotherapy of Breast Cancer
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.
Read the detailed description
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
- Radiation Pneumonitis
- Being tested
- hyperbaric oxygen therapy
- Keywords
- Hyperbaric Oxygen, Radiation Pneumonitis, Breast Cancer, Radiotherapy, Chemotherapy
- Medical subject headings
- Radiation Pneumonitis, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperbaric oxygen therapyBehavioural
hyperbaric oxygen therapy
| Study group | Role | What they receive |
|---|---|---|
| hyperbaric oxygen therapy group | Experimental | 30-40 times hyperbaric oxygen therapy Receives: Behavioral: hyperbaric oxygen therapy |
| control group | No intervention | No hyperbaric oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of radiation pneumonitis
Rate of enrolled participants with radiation pneumonitis
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start1 Mar 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation PneumonitisStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189496
- Sponsor's protocol ID
- KY-Q-2021-182
- Status last verified
- Feb 2025
- First submitted
- 29 Dec 2021
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: there is no plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effectiveness and Safety of Hyperbaric Oxygen Therapy for Preventing Radiation Pneumonitis Caused by Radiotherapy and Chemotherapy of Breast Cancer
- ClinicalTrials.gov ID
- NCT05189496
- Acronym / sponsor ID
- KY-Q-2021-182
- Conditions
- Radiation Pneumonitis
- Keywords
- Hyperbaric Oxygen, Radiation Pneumonitis, Breast Cancer, Radiotherapy, Chemotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyperbaric oxygen therapy group | Experimental | Behavioral: hyperbaric oxygen therapy30-40 times hyperbaric oxygen therapy |
| control group | No intervention | –No hyperbaric oxygen therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- (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.
Key exclusion criteria (4 listed)
- (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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyperbaric oxygen therapyhyperbaric oxygen therapy | Behavioural | hyperbaric oxygen therapy group |
Primary outcome
Incidence of radiation pneumonitis
Time frame: 1 year
Rate of enrolled participants with radiation pneumonitis
1 secondary outcome
Grade of symptoms related to radiation pneumonitis
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: No. there is no plan to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hyperbaric oxygen therapy in people with Radiation Pneumonitis, run by Guangdong Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kun Wang (13922118086, gzwangkun@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of radiation pneumonitis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.