NL-OMON55553已完成3 期
The effect of Hyperbaric OxygeN therapy on brEast cancer patients with late radiation toxicitY - UMBRELLA HONEY
niversitair Medisch Centrum Utrecht0 个研究点目标入组 240 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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;
- •- Finished surgery and (neo)adjuvant systemic therapy except adjuvant endocrine
- •therapy, for breast cancer.
排除标准
- •- Poor responder (i.e. return of <= 2 UMBRELLA questionnaires);
- •- Previous HBOT;
- •- Contra-indications for HBOT (e.g. (severe) COPD/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).
研究者
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