NCT00790296终止2 期
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
UConn Health1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2006年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Change in Visual Analog Scale for Energy (VAS-E)Score From Baseline to 7 Hrs Post Study Medication Infusion
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Saline
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
Thyrotropin releasing hormone (TRH)
Experimental
TRH
干预措施: Thyrotropin releasing hormone (TRH) (Drug)
结局指标
主要结局
Change in Visual Analog Scale for Energy (VAS-E)Score From Baseline to 7 Hrs Post Study Medication Infusion
时间窗: Baseline and 7 hours post study medication infusion
1 to 100 scale with 1 referring to No Energy and 100 referring to Normal Energy.
次要结局
未报告次要终点
研究者
研究点 (1)
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