跳至主要内容
临床试验/NCT03185780
NCT03185780撤回不适用

Impact of Complementary/Integrative Medicine Treatments on Patients With Brain Cancer: A Pilot Study

The Chaim Sheba Medical Center0 个研究点开始时间: 2018年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
主要终点
Measure Yourself Concerns and Wellbeing (MYCAW) study tool

研究概览

简要总结

Nearly a quarter of a million patients are diagnosed each year with tumors of the central nervous system, a third of them malignant. The most common malignant tumor of the brain is the high grade glioma( HGG), whose treatment begins with surgical resection of the tumor, followed by a combined chemo-radiation regimen, with the drug Temodal (temozolomide). This treatment is often accompanied by toxic effects (e.g., nausea, headache, constipation, weakness/fatigue, and others), with treatment of these effects limited in their effectiveness and safety. Complementary medicine treatments such as acupuncture and touch therapies (reflexology, Shiatsu, etc.) have been researched and found to be both safe and effective for some of the toxic effects of oncology treatment regimens.

The present pilot study is set to examine the impact of complementary medicine on the toxic effects of the conventional treatment for HGG. The study will include 40 patients and will last for two years, during which patients will be treated with acupuncture and/or touch therapies, this in parallel to their chemo-radiation regimen. The primary study outcome will be the scores on four Patient-Reported Outcome Measures (PROMs): the Measure Yourself Concerns and Wellbeing (MYCAW) study tool; the Functional Assessment of Cancer Therapy, Brain Cancer (FACT-Br) questionnaire; the Edmonton Symptom Assessment Scale (ESAS); and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-c30). Secondary study outcomes will include the safety of the complementary medicine treatments, and adherence to the planned oncology treatment regimen, as measured by the Relative Dose Intensity (RDI) calculation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patient aged 18 years and older
  • diagnosed with high grade glioma (stage III-IV)
  • following surgical intervention (tumor resection)
  • prior to chemo-radiation treatment
  • signing of informed consent form

排除标准

  • inability/unwillingness to sign informed consent form
  • unwillingness of treating oncologist to allow participation in the study

研究组 & 干预措施

Treatment

Experimental

Patients will be treated with acupuncture and/or touch therapies, this in parallel to their chemo-radiation regimen. These treatments will be administered twice-weekly during active chemo-radiation treatment (6 weeks), followed by once-weekly treatment throughout the remainder of the study period (6 months)

干预措施: Acupuncture (Other)

结局指标

主要结局

Measure Yourself Concerns and Wellbeing (MYCAW) study tool

时间窗: 6 months

Patient-Reported Outcome Measure - Quality of Life Assessment

Functional Assessment of Cancer Therapy, Brain Cancer (FACT-Br) questionnaire

时间窗: 6 months

Patient-Reported Outcome Measure - Quality of Life Assessment

Edmonton Symptom Assessment Scale (ESAS)

时间窗: 6 months

Patient-Reported Outcome Measure - Quality of Life Assessment

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-c30)

时间窗: 6 months

Patient-Reported Outcome Measure - Quality of Life Assessment

次要结局

  • Adverse effects attributed to the complementary/integrative medicine treatments(6 months)
  • RDI - relative dose intensity(6 months)

研究者

发起方
The Chaim Sheba Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Noah Samuels

Medical Director, Tal Center for Integrative Oncology, Institute of Oncology

The Chaim Sheba Medical Center

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