Evaluation of Synthetic Thyrotropin Releasing Hormone (TRH) as a Treatment for Cancer-related Fatigue
2017年12月4日 更新者:UConn Health
A Pilot, Randomized Double-Blind Placebo-Controlled Crossover Study of Synthetic Thyrotropin Releasing Hormone (TRH) Administration for the Treatment of Fatigue in Patients With Cancer
The primary objective of the study is to evaluate thyrotropin releasing hormone (TRH) as a treatment for cancer-related fatigue.
The central hypothesis of this pilot study is that TRH is more efficacious than placebo in alleviating cancer-related fatigue in patients with breast or prostate cancer.
研究概览
研究类型
介入性
注册 (实际的)
11
阶段
- 阶段2
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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Connecticut
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Farmington、Connecticut、美国、06030
- University of Connecticut Health Center
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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
18年 及以上 (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
Inclusion Criteria:
- Patients with a diagnosis of cancer who have undergone or are currently undergoing radiation or chemotherapy therapy and are expected not to have any significant change in cancer treatment sessions during the study period
- Provide written informed consent prior to initiation of any study-related procedures.
- Male or female, 18 years of age or older with a diagnosis of cancer.
- Able to understand and comply with the requirements of the study.
Exclusion criteria:
- Hospitalized patients.
- Patients with an identifiable diagnosis of substance abuse or dependence within 6 months prior to evaluation (except those in full remission, or those with caffeine or nicotine dependence) as defined by DSM-IV criteria.
- Patients with any of the following cardiovascular symptomatology.
- Office systolic BP > 160mmHg and/or diastolic BP > 90mmHg.
- Persons with a resting hear rate of > 100 beats per minute
- Persons with a history of chronic stable angina
- Persons with myocardial infarction or unstable angina or vascular surgery within 6 months
- Persons with history of vaso-vagal or other syncopal episodes
- Patients with any known clinically significant cardiac problems
- Patients with any history of stroke or at significant risk for stroke.
- Patients with a history of seizures
- Patients with a history of asthma
- Patients with any clinically significant unstable or inadequately treated co- morbid medical condition or patients currently on medications that would confound evaluation of CF (e.g. diabetes, CHF, history of other cancers) as judged by the investigator.
- Patients with any clinically significant, unstable psychiatric disorder (except mild to moderate depressive or anxiety disorders) or patients on psychotropic medications that would confound CF assessment as judged by the investigator. Patients with history of depressive or anxiety disorders will not be excluded from the study
- Patients with a history of illnesses or treatments that would be expected to significantly alter immune function (viz. HIV infection, systemic lupus erythematosus, patients taking immunosuppressive medications).
- Patients with diseases or on medications that significantly affect the hypothalamic-pituitary-adrenocortical (HPA) axis function (viz. Cushings disease).
- Pregnant patients, breastfeeding or plans to become pregnant during the study
- Patients with known allergy to TRH
- Any other condition, which, in the opinion of the investigator, would make the patient, unsuited for enrollment, confound CF evaluation or could interfere with the patient's participation in the study.
- Patients with medically reversible causes of CF (viz., anemia, hypothyroidism, electrolyte abnormalities etc).
- Patients with potentially treatable associated symptoms dominating the CF scenario such as pain, or sleep disturbances which may have a significant causal relationship to CF.
- Patients identified as pregnant based on the pregnancy test during screening.
- Patients physically unable to complete the walking test (WT) assessment or when the WT would increase risk for medical complications
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?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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安慰剂比较:盐水
安慰剂
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盐水
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实验性的:Thyrotropin releasing hormone (TRH)
TRH
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0.5mg and 1.5mg
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change in Visual Analog Scale for Energy (VAS-E)Score From Baseline to 7 Hrs Post Study Medication Infusion
大体时间:Baseline and 7 hours post study medication infusion
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1 to 100 scale with 1 referring to No Energy and 100 referring to Normal Energy.
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Baseline and 7 hours post study medication infusion
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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。
赞助
调查人员
- 首席研究员:Andrew Winokur, MD PhD、UConn Health
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
2006年12月1日
初级完成 (实际的)
2010年2月1日
研究完成 (实际的)
2010年3月1日
研究注册日期
首次提交
2008年11月10日
首先提交符合 QC 标准的
2008年11月10日
首次发布 (估计)
2008年11月13日
研究记录更新
最后更新发布 (实际的)
2017年12月28日
上次提交的符合 QC 标准的更新
2017年12月4日
最后验证
2017年12月1日
更多信息
与本研究相关的术语
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.
安慰剂的临床试验
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City of Hope Medical CenterNational Cancer Institute (NCI)主动,不招人造血和淋巴细胞肿瘤 | 骨髓纤维化 | 慢性淋巴细胞白血病 | 缓解期成人急性髓性白血病 | 骨髓增生异常综合症 | 缓解期成人急性淋巴细胞白血病 | 骨髓增殖性肿瘤 | 慢性期慢性粒细胞白血病,BCR-ABL1 阳性 | 成人淋巴母细胞淋巴瘤 | 加速期慢性粒细胞白血病,BCR-ABL1 阳性 | HLA-A*0201 阳性细胞存在 | 巨细胞病毒感染 | 成人霍奇金淋巴瘤 | 成人非霍奇金淋巴瘤美国
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Mila (bMotion Technologies)完全的
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Universidad Autonoma de MadridCentro Universitario La Salle完全的