Clinical trial NCT00790296: Evaluation of Synthetic Thyrotropin Releasing Hormone (TRH) as a Treatment for Cancer-related Fatigue
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cancer-related Fatigue
Keywords: cancer fatigue
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: Susan G. Komen Breast Cancer Foundation
name: Hollfelder foundation
First posted: 2008-11-13
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Visual Analog Scale for Energy (VAS-E)Score From Baseline to 7 Hrs Post Study Medication Infusion
timeFrame: Baseline and 7 hours post study medication infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
Study officials:
affiliation: UConn Health
name: Andrew Winokur, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: