跳至主要内容
临床试验/EUCTR2019-002635-28-NL
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

niversity Medical Center Utrecht0 个研究点目标入组 120 人开始时间: 2019年10月14日最近更新:
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

相似试验