Back to results

Hyperbaric Oxygen in the Prevention of Radiation Pneumonitis

Primary Purpose

Radiation Pneumonitis

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

hyperbaric oxygen therapy

About this trial

This is an interventional prevention trial for Radiation Pneumonitis focused on measuring Hyperbaric Oxygen, Radiation Pneumonitis, Breast Cancer, Radiotherapy, Chemotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Guangdong Provincial People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

hyperbaric oxygen therapy group

control group

Arm Description

30-40 times hyperbaric oxygen therapy

No hyperbaric oxygen therapy

Outcomes

Primary Outcome Measures

Incidence of radiation pneumonitis

Rate of enrolled participants with radiation pneumonitis

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05189496

First Posted

December 29, 2021

Last Updated

March 17, 2022

Sponsor

Guangdong Provincial People's Hospital

Collaborators

First Affiliated Hospital, Sun Yat-Sen University

1. Study Identification

Unique Protocol Identification Number

NCT05189496

Brief Title

Hyperbaric Oxygen in the Prevention of Radiation Pneumonitis

Official Title

Study on the Effectiveness and Safety of Hyperbaric Oxygen Therapy for Preventing Radiation Pneumonitis Caused by Radiotherapy and Chemotherapy of Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 1, 2022 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Guangdong Provincial People's Hospital

Collaborators

First Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Radiation Pneumonitis

Keywords

Hyperbaric Oxygen, Radiation Pneumonitis, Breast Cancer, Radiotherapy, Chemotherapy

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

380 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

hyperbaric oxygen therapy group

Arm Type

Experimental

Arm Description

30-40 times hyperbaric oxygen therapy

Arm Title

control group

Arm Type

No Intervention

Arm Description

No hyperbaric oxygen therapy

Intervention Type

Behavioral

Intervention Name(s)

hyperbaric oxygen therapy

Intervention Description

hyperbaric oxygen therapy

Primary Outcome Measure Information:

Title

Incidence of radiation pneumonitis

Description

Rate of enrolled participants with radiation pneumonitis

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Grade of symptoms related to radiation pneumonitis

Description

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kun Wang

Phone

13922118086

gzwangkun@126.com

Facility Information:

Facility Name

Guangdong Provincial People's Hospital

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510080

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kun Wang

Phone

13922118086

gawangkun@126.com

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

there is no plan to make individual participant data (IPD) available to other researchers.

Learn more about this trial

Hyperbaric Oxygen in the Prevention of Radiation Pneumonitis

We'll reach out to this number within 24 hrs