Efficacy and Safety of Hyperbaric Oxygen Therapy for Radiation Dermatitis in Patients with Localized Breast Cancer : a Randomized Controlled, Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- incidence of grade 2 or more dermatitis according to RTOG toxicity scale
研究概览
简要总结
This study aimed to evaluate reducing the incidence of radiation dermatitis by assigning hyperbaric oxygen therapy to patients with localized breast cancer.
详细描述
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.
- Comparison of the incidence of radiation dermatitis according to RTOG grade
- Catterall skin scoring profile score comparison
- Comparison of Skindex-29 questionnaire scores
- Numeric rating scale score comparison
- Investigation of radiation therapy dose, frequency, schedule, and medical history
- Health-related quality of life questionnaire (EORTC-QLQ-C30)
- Health-related quality of life measurement tool (EQ-5D)
- Safety evaluation
- Health-related quality of life measurement tool (EQ-5D)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
incidence of grade 2 or more dermatitis according to RTOG toxicity scale
时间窗: At the end of 6 weeks
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)
次要结局
- EQ-5D(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)
- 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)
- 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)
- Drug Consumption(At the end of Day 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10)
- Adverse events(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)
研究者
Jee Young Lee
assistant professor
CHA University