Status:
COMPLETED
Efficacy and Safety of Hyperbaric Oxygen Therapy for Radiation Dermatitis in Patients with Localized Breast Cancer
Lead Sponsor:
Ilsan Cha hospital
Conditions:
Breast Cancer
Radiation Dermatitis
Eligibility:
FEMALE
19-69 years
Phase:
NA
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 HB...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06158347
Start Date
November 6 2023
End Date
September 25 2024
Last Update
November 20 2024
Active Locations (1)
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1
Lee Jee Young
Goyang-si, Gyeonggi-do, South Korea, 10414