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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

Phase 2
18 Years
Not Enrolling
Cancer-related Fatigue

Thank you

Trial Information

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

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Change in Visual Analog Scale for Energy (VAS-E)Score From Baseline to 7 Hrs Post Study Medication Infusion

Outcome Description:

1 to 100 scale with 1 referring to No Energy and 100 referring to Normal Energy.

Outcome Time Frame:

Baseline and 7 hours post study medication infusion

Safety Issue:


Principal Investigator

Andrew Winokur, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Connecticut Health Center


United States: Food and Drug Administration

Study ID:




Start Date:

December 2006

Completion Date:

March 2010

Related Keywords:

  • Cancer-Related Fatigue
  • cancer fatigue
  • Fatigue



University of Connecticut Health Center Farmington, Connecticut  06360-7106