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 人待定
概览
- 阶段
- 3 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Breast cancer
- 发起方
- niversitair Medisch Centrum Utrecht
- 入组人数
- 240
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
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).
结局指标
主要结局
未指定
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