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

NCT ID: NCT06158347

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-06
• Study Completion Date: 2024-09-25

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HBOT group

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.

Group Type: EXPERIMENTAL

hyperbaric oxygen chamber

Intervention Type: 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).

control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ilsan Cha hospital

OTHER

Sponsor Role: lead

Responsible Party

Jee Young Lee

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jee Youg Lee

Role: PRINCIPAL_INVESTIGATOR

Ilsan Cha hospital

Locations

Lee Jee Young

Goyang-si, Gyeonggi-do, South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 40259026 (View on PubMed)

Other Identifiers

ICICC-CT-23-01

Identifier Type: -

Identifier Source: org_study_id