Efficacy and Safety of Hyperbaric Oxygen Therapy for Radiation Dermatitis in Patients with Localized Breast Cancer

NCT06158347 | Completed

• 1 other identifier: ICICC-CT-23-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer; Radiation Dermatitis

Outcome Measures

Primary Outcomes (1)

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

  ① Grade 0: No change before or after treatment (No change over baseline) * Grade 1: Cystic lesions, erythema with faint or reduced skin luster, implantation, dry epidermis shedding, and decreased sweating. (Follicular, faint or dull erythema, epilation, dry desquamation, decreased sweating) * Grade 2: Tender or bright erythema, ecchymosis, desquamation of the wet epidermis, and moderate edema. (Tender or bright erythema, patchy moist desquamation, moderate edema) * Grade 3: Confluent skin lesions, desquamation of the wet epidermis other than the area where the skin is folded, pitting edema (Confluent, moist desquamation other than skin folds, pitting edema) * Grade 4: Ulcerative bleeding, skin necrosis (Ulceration hemorrhage, necrosis)

  At the end of 6 weeks

Secondary Outcomes (8)

• RTOG toxicity

  At the end of Day 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10

• CSSP

  At the end of Day 1, week 5, week 8, week 9, week 10

• skindex-29

  At the end of Day 1, week 5, week 8, week 9, week 10

• NRS

  At the end of Day 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10

• EORTC

  At the end of Day 1, week 5, week 8, week 9, week 10

Study Arms (2)

HBOT group

EXPERIMENTAL

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.

Device: hyperbaric oxygen chamber

control group

NO INTERVENTION

The control group will receive systemic education in dermal care and will be under the instruction of usual self-care.

Interventions

hyperbaric oxygen chamber DEVICE

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).

HBOT group

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ilsan Cha hospital: lead

Study Sites (1)

Lee Jee Young

Goyang-si, Gyeonggi-do, 10414, South Korea

Location

Related Publications (1)

• Lee 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 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Radiodermatitis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Dermatitis; Radiation Injuries; Wounds and Injuries

Study Officials

• Jee Youg Lee

  Ilsan Cha hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: December 6, 2023
• Study Start: November 6, 2023
• Primary Completion: September 6, 2024
• Study Completion: September 25, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)