The Effect of Hyperbaric Oxygen Therapy on Breast Cancer Patients With Late Radiation Toxicity
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- Change in breast/chest wall pain: EORTC QLQ-BR23 questionnaire
研究概览
简要总结
The "Hyperbaric OxygeN therapy on brEast cancer patients with late radiation toxicity" (HONEY) trial aims to evaluate the effectiveness of HBOT on late radiation toxicity in breast cancer patients using the trial within cohorts (TwiCs) design.
详细描述
Objective
The aim of this study is to assess whether HBOT reduces pain, and improves physical functioning and QoL in breast cancer patients with late radiation toxicity.
Study design: Randomized controlled trial, nested within the prospective UMBRELLA breast cancer cohort according to the TWiC's design. UMBRELLA is a prospective cohort study including all breast cancer patients visiting the University Medical Center (UMC) Utrecht department of Radiotherapy. In total 120 patients will be randomized in a ratio of 2:1.
Study population: Breast cancer patients participating in the UMBRELLA cohort who have given informed consent to be invited for future research (e.g. cmRCT's), and who have reported symptoms of late radiation toxicity.
Intervention: Eligible patients will be referred to the HBO center for a standard HBO treatment. HBOT consists of 30-40 treatment sessions (1 session per day during 5 days per week). During the hyperbaric oxygen (HBO) sessions patients breath in 100% oxygen during 4 times 20 minutes in a hyperbaric chamber.
Main study parameters/endpoints: The primary endpoint of this study is patient reported breast/chest wall pain. Secondary endpoints are: physical functioning, QoL cosmetic outcome, physician reported pain and radiation toxicity (according to CTCAE criteria version 4.03, tissue oxygenation previous to HBOT and after HBOT and side-effects of HBOT.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Self reported pain grade 3-4 (on a scale of 1-4) as assessed by the late radiation toxicity questionnaire;
- •Participation >12 months in the UMBRELLA cohort;
- •Previous treatment with radiotherapy for breast cancer;
- •Completed surgery and (neo)adjuvant systemic therapy except adjuvant endocrine therapy, for breast cancer.
排除标准
- •Poor responder to questionnaires (i.e. return of ≤ 2 UMBRELLA questionnaires);
- •Previous HBOT;
- •Contra-indications for HBOT (e.g. (severe) chronic obstructive pulmonary disease (COPD) or asthma, pacemaker, morbid obesity, epilepsy in medical history, severe heart failure);
- •Current metastatic disease or recurrent breast cancer.
- •Additional exclusions criteria based on screening visit:
- •Inability to follow schedule of all consecutive HBO treatments (e.g. due to scheduled holidays > 2 days);
- •Not meeting criteria for HBOT (e.g. due to complaints similar to late radiation toxicity, not caused by radiotherapy).
研究组 & 干预措施
Hyperbaric oxygen therapy
Hyperbaric oxygen therapy consists of 30-40 treatment sessions (1 session per day during 5 days per week). During the hyperbaric oxygen (HBO) sessions the pressure will be raised to 2.4 atmospheres absolute in a hyperbaric chamber and patients breath in 100% oxygen during 4 times 20 minutes.
干预措施: Hyperbaric oxygen therapy (Drug)
结局指标
主要结局
Change in breast/chest wall pain: EORTC QLQ-BR23 questionnaire
时间窗: Baseline and 6 months after baseline (i.e. 3 months after HBOT)
The primary endpoint of this study is the difference in proportion of patient-reported breast/chest wall pain grade 3-4 between control and intervention group. Pain is assessed by means of the EORTC QLQ-BR23 questionnaire on a 4-point Likert scale. At baseline all patients have a pain score of 3 or 4 (see inclusion criteria). The proportion of patients with 3-4 at 6 months will be compared between intervention and control group. A higher score indicates more pain.
次要结局
- Change in patient-reported quality of life: (EORTC QLQ) C30(Baseline and 6 months after baseline (i.e. 3 months after HBOT))
- Change in patient-reported late radiation toxicity(Baseline and 6 months after baseline (i.e. 3 months after HBOT))
- Physician-reported late radiation toxicity(Baseline (prior to HBOT), 3 months after baseline (i.e. after HBOT) and 6 months after baseline (i.e. 3 months after the last HBO session))
- Patient-reported cosmetic outcome(Baseline and 6 months after baseline (i.e. 3 months after HBOT))
- Physician-reported cosmetic outcome(Baseline and 6 months after baseline (i.e. 3 months after HBOT))
- Number of participants with side effects of treatment with hyperbaric oxygen therapy(During hyperbaric oxygen treatment sessions and at 3 months after last HBO session)
- Oxygenation of the skin(Baseline and prior to last hyperbaric oxygen session (i.e. 3 months after baseline).)