Hyperbaric Oxygen in the Prevention of Radiation Pneumonitis

NCT05189496 | Recruiting

• 1 other identifier: KY-Q-2021-182
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Pneumonitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of radiation pneumonitis

  Rate of enrolled participants with radiation pneumonitis

  1 year

Secondary Outcomes (1)

• Grade of symptoms related to radiation pneumonitis

  1 year

Study Arms (2)

hyperbaric oxygen therapy group

EXPERIMENTAL

30-40 times hyperbaric oxygen therapy

Behavioral: hyperbaric oxygen therapy

control group

NO INTERVENTION

No hyperbaric oxygen therapy

Interventions

hyperbaric oxygen therapy BEHAVIORAL

hyperbaric oxygen therapy

hyperbaric oxygen therapy group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• (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.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead
• First Affiliated Hospital, Sun Yat-Sen University: collaborator

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Radiation Pneumonitis; Breast Neoplasms

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Lung Injury; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Central Study Contacts

Kun Wang

CONTACT

13922118086; gzwangkun@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 12, 2022
• Study Start: March 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)