NCT06158347

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: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Ilsan Cha hospital · Academic / Other
• Sex: Female
• Age: 19 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

This study aimed to evaluate reducing the incidence of radiation dermatitis by assigning hyperbaric oxygen therapy to patients with localized breast cancer.

Detailed description

To evaluate the efficacy of hyperbaric oxygen therapy (HBOT) on the prevention of radiation dermatitis, patients with localized breast cancer between the ages of 19 and 69 were randomly assigned to HBOT group and usual care group in a 1:1 ratio during the period of adjuvant radiotherapy. The primary purpose of this study was to administer oxygen therapy three times a week during the radiotherapy period for those who were recommended to receive radiotherapy with a Biological equivalent dose (BED10) of 60 Gy or more as adjuvant radiotherapy after breast-conserving surgery to determine the radiation at the end of radiotherapy. The purpose is to compare the incidence of radiation dermatitis of therapy oncology group grade (RTOG grade) grade 2 or higher between the two groups. The secondary purpose of this study is to evaluate/compare the following items in the relevant treatment group. 1. Comparison of the incidence of radiation dermatitis according to RTOG grade 2. Catterall skin scoring profile score comparison 3. Comparison of Skindex-29 questionnaire scores 4. Numeric rating scale score comparison 5. Investigation of radiation therapy dose, frequency, schedule, and medical history 6. Health-related quality of life questionnaire (EORTC-QLQ-C30) 7. Health-related quality of life measurement tool (EQ-5D) 8. Safety evaluation 9. Health-related quality of life measurement tool (EQ-5D)

Conditions

• Breast Cancer
• Radiation Dermatitis

Interventions

Type	Name	Description
DEVICE	hyperbaric oxygen chamber	Hyperbaric oxygen therapy allows patients to breathe 100% oxygen through an O2 Fresh M50 (HBOT Medical, Wonju, South Korea) chamber. Upon entering the chamber, oxygen is supplied by gradually increasing the barometric pressure from normal pressure to 1.5 atmospheres absolute (ATA).

Timeline

• Start date: 2023-11-06
• Primary completion: 2024-09-06
• Completion: 2024-09-25
• First posted: 2023-12-06
• Last updated: 2024-11-20

Locations

1 site across 1 country: South Korea