Clinical trial NCT06158347: Efficacy and Safety of Hyperbaric Oxygen Therapy for Radiation Dermatitis in Patients with Localized Breast Cancer
Official title: Efficacy and Safety of Hyperbaric Oxygen Therapy for Radiation Dermatitis in Patients with Localized Breast Cancer : a Randomized Controlled, Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Radiation Dermatitis
Lead sponsor: Ilsan Cha hospital
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 30
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: incidence of grade 2 or more dermatitis according to RTOG toxicity scale
timeFrame: At the end of 6 weeks
Secondary outcomes:
measure: RTOG toxicity
timeFrame: At the end of Day 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10
measure: CSSP
timeFrame: At the end of Day 1, week 5, week 8, week 9, week 10
measure: skindex-29
timeFrame: At the end of Day 1, week 5, week 8, week 9, week 10
measure: NRS
timeFrame: At the end of Day 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10
measure: EORTC
timeFrame: At the end of Day 1, week 5, week 8, week 9, week 10
measure: EQ-5D
timeFrame: At the end of Day 1, week 5, week 8, week 9, week 10
measure: Drug Consumption
timeFrame: At the end of Day 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10
measure: Adverse events
timeFrame: At the end of Day 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: Lee Jee Young
state: Gyeonggi-do
Study officials:
affiliation: Ilsan Cha hospital
name: Jee Youg Lee
role: PRINCIPAL_INVESTIGATOR
References: