EUCTR2019-002635-28-NL进行中(未招募)1 期
The effect of hyperbaric oxygen therapy on breast cancer patients with late radiation toxicity - UMBRELLA HONEY
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
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 exclusion 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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