Clinical trial · Interventional
Efficacy and Safety of Hyperbaric Oxygen Therapy for Radiation Dermatitis in Patients with Localized Breast Cancer
Efficacy and Safety of Hyperbaric Oxygen Therapy for Radiation Dermatitis in Patients with Localized Breast Cancer : a Randomized Controlled, Pilot Study
NCT06158347CI-TRIAL-00082745HBOTcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aimed to evaluate reducing the incidence of radiation dermatitis by assigning hyperbaric oxygen therapy to patients with localized breast cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Radiation Dermatitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hyperbaric oxygen chamber | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HBOT group
- description
- Hyperbaric oxygen therapy allows the patient to breathe 100% oxygen through an O2 Fresh M50 (HBOT Medical, Wonju, South Korea) chamber. Upon entering the chamber, oxygen is supplied while gradually increasing the atmospheric pressure from normal atmospheric pressure to 1.5 atmospheres absolute (ATA). If the intensity acceptable to the clinical research subject is lower than 1.5 ATA, maintain it at the point acceptable to the research subject and record that value.
- interventionNames
- Device: hyperbaric oxygen chamber
- type
- NO_INTERVENTION
- label
- control group
- description
- The control group will receive systemic education in dermal care and will be under the instruction of usual self-care.
Primary outcomes (1)
- measure
- incidence of grade 2 or more dermatitis according to RTOG toxicity scale
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: 1. Between the ages of 19 and 69 2. Patients with biopsy confirmed invasive breast cancer 3. Patients who have undergone breast-conserving surgery for the purpose of tumor resection and require adjuvant radiotherapy or have undergone adjuvant radiotherapy within 5 times. 4. The Eastern Cooperative Oncology Group (ECOG) performance status 0-1 5. Those who understand the content of the study, agree to participate in the study, and provide written informed consent Exclusion Criteria: 1. Subjects with distant metastases of cancer 2. Those whose cancer has invaded the skin of the breast (T4) or who have unhealed wounds on the skin 3. Patients who have a history of radiotherapy of the cervical thoracic region for other reasons in the past 4. Patients with a history of connective tissue disease 5. Subjects with uncontrolled diabetes with HbA1c 7.0 or higher 6. Pneumothorax and symptomatic upper respiratory tract infection 7. If it is judged that there will be a significant decrease in respiratory function 8. Undergoing treatments known to interact with hyperbaric oxygen therapy, such as cisplatin, doxorubicin, bleomycin, disulfiram, etc. 9. When it is judged that diseases other than cancer (dementia, cerebrovascular disease, severe renal failure, etc.) may have a significant effect on the decline of physical function. 10. If it is determined that the life expectancy is not sufficient follow-up within 3 months. 11. Pregnant and lactating women 12. Other persons who are judged by the researcher to be unsuitable for research
References
Publications (1)
- DERIVEDLee JY, Hyun MH, Yang G, Lee S. Efficacy and safety of hyperbaric oxygen therapy for radiation-induced dermatitis in patients with breast cancer: a randomized pilot study. Support Care Cancer. 2025 Apr 21;33(5):399. doi: 10.1007/s00520-025-09463-0. PMID 40259026