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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0009847
Enrollment
30
Registered
2024-10-15
Start date
2023-11-06
Completion date
Unknown
Last updated
2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : Hyperbaric oxygen therapy (HBOT) will be administered through the O2 Fresh M50 (HBOT Medical, Wonju, South Korea) chamber, allowing the patient to breathe 100% oxygen. Upon enterin

Sponsors

CHA University Ilsan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Between the ages of 19 and 69 Patients with biopsy confirmed invasive breast cancer 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. When lymph nodes are included in the required irradiation range The Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Those who understand the content of the study, agree to participate in the study, and provide written informed consent

Exclusion criteria

Exclusion criteria: Subjects with distant metastases of cancer Those whose cancer has invaded the skin of the breast (T4) or who have unhealed wounds on the skin Patients who have a history of radiotherapy of the cervical thoracic region for other reasons in the past Patients with a history of connective tissue disease Subjects with uncontrolled diabetes with HbA1c 7.0 or higher Pneumothorax and symptomatic upper respiratory tract infection If it is judged that there will be a significant decrease in respiratory function Undergoing treatments known to interact with hyperbaric oxygen therapy, such as cisplatin, doxorubicin, bleomycin, disulfiram, etc. 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. If it is determined that the life expectancy is not sufficient follow-up within 3 months. Pregnant and lactating women Other persons who are judged by the researcher to be unsuitable for research

Design outcomes

Primary

MeasureTime frame
incidence of grade 2 or more dermatitis according to RTOG toxicity scale

Secondary

MeasureTime frame
radiation therapy oncology group grade (RTOG grade) ;Modified 10-point Catterall skin scoring profile (CSSP);skindex-29;EORTC-QLQ-C30;numeric rating scale

Countries

Korea, Republic of

Contacts

Public ContactJee Young Lee

CHA University Ilsan Medical Center

happiade@chamc.co.kr+82-31-782-3108

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 5, 2026