Survey of the Use of Alternative Medical Therapies in Adult Cancer Patients Enrolled in Phase I Clinical Trials
2008年3月3日 更新者:National Cancer Institute (NCI)
Simultaneous use of alternative or complementary medical therapies by cancer patients undergoing conventional medical treatment is extremely common and may not always be disclosed to the patient's treating physician.
Cancer patients undergoing Phase I therapy on clinical trials constitute a special population of patients, since by definition, their prescribed therapy is scientifically unproven in terms of efficacy.
Phase I patients are closely monitored for adverse effects in order to identify and characterize the toxicities and to define a tolerable dose of their experimental treatment.
Thus, the unrecognized use of alternative therapies by patients actively enrolled in phase I trials may potentially confound rational drug development by causing adverse side effects or by contributing to drug interactions.
Examples of clinical toxicities induced by alternative medical treatments include liver dysfunction or renal failure caused by herbal preparations, or hematologic abnormalities, such as eosinophilia-myalgia syndrome caused by tryptophan food supplements.
Therefore, it is important to document and determine the prevalence of alternative therapy use in this specific patient population; however, this issue has not previously been examined in a scientifically rigorous manner.
We propose to conduct a survey and interview study of phase I cancer patients enrolled in ongoing clinical trials at the National Cancer Institute to determine the prevalence of alternative therapy use in this population.
This study will also examine patient attitudes and perceptions regarding their use of alternative therapy as compared with their scientifically-sanctioned phase I experimental therapy.
This information has important implications for drug development.
研究概览
地位
完全的
条件
详细说明
Simultaneous use of alternative or complementary medical therapies by cancer patients undergoing conventional medical treatment is extremely common and may not always be disclosed to the patient's treating physician.
Cancer patients undergoing Phase I therapy on clinical trials constitute a special population of patients, since by definition, their prescribed therapy is scientifically unproven in terms of efficacy.
Phase I patients are closely monitored for adverse effects in order to identify and characterize the toxicities and to define a tolerable dose of their experimental treatment.
Thus, the unrecognized use of alternative therapies by patients actively enrolled in phase I trials may potentially confound rational drug development by causing adverse side effects or by contributing to drug interactions.
Examples of clinical toxicities induced by alternative medical treatments include liver dysfunction or renal failure caused by herbal preparations, or hematologic abnormalities, such as eosinophilia-myalgia syndrome caused by tryptophan food supplements.
Therefore, it is important to document and determine the prevalence of alternative therapy use in this specific patient population; however, this issue has not previously been examined in a scientifically rigorous manner.
We propose to conduct a survey and interview study of phase I cancer patients enrolled in ongoing clinical trials at the National Cancer Institute to determine the prevalence of alternative therapy use in this population.
This study will also examine patient attitudes and perceptions regarding their use of alternative therapy as compared with their scientifically-sanctioned phase I experimental therapy.
This information has important implications for drug development.
研究类型
观察性的
注册
125
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
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Maryland
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Bethesda、Maryland、美国、20892
- National Cancer Institute (NCI)
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
全部
描述
Patients must be registered and actively participating in a Phase I clinical trial in the Division of Hematology/Oncology, National Naval Medical Center.
Patients must be able to give signed, informed consent.
Patients must be greater than or equal to 18 years old.
Patients must be medically well enough to be interviewed and to fill out the study questionnaire.
Patients must not have been previously enrolled in this study.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Eisenberg DM, Kessler RC, Foster C, Norlock FE, Calkins DR, Delbanco TL. Unconventional medicine in the United States. Prevalence, costs, and patterns of use. N Engl J Med. 1993 Jan 28;328(4):246-52. doi: 10.1056/NEJM199301283280406.
- Cassileth BR, Chapman CC. Alternative and complementary cancer therapies. Cancer. 1996 Mar 15;77(6):1026-34. No abstract available.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
1998年4月1日
研究完成
2002年1月1日
研究注册日期
首次提交
1999年11月3日
首先提交符合 QC 标准的
1999年11月3日
首次发布 (估计)
1999年11月4日
研究记录更新
最后更新发布 (估计)
2008年3月4日
上次提交的符合 QC 标准的更新
2008年3月3日
最后验证
2002年1月1日
更多信息
与本研究相关的术语
其他研究编号
- 980098
- 98-C-0098
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.