Evaluation of Synthetic Thyrotropin Releasing Hormone (TRH) as a Treatment for Cancer-related Fatigue

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.

Study Overview

• Status: Terminated
• Conditions: Cancer-related Fatigue
• Intervention / Treatment: Drug: Placebo; Drug: Thyrotropin releasing hormone (TRH)

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • University of Connecticut Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Saline; Placebo	Drug: Placebo; Saline
Experimental: Thyrotropin releasing hormone (TRH); TRH	Drug: Thyrotropin releasing hormone (TRH); 0.5mg and 1.5mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Visual Analog Scale for Energy (VAS-E)Score From Baseline to 7 Hrs Post Study Medication Infusion	1 to 100 scale with 1 referring to No Energy and 100 referring to Normal Energy.	Baseline and 7 hours post study medication infusion

Collaborators and Investigators

• Sponsor: UConn Health
• Collaborators: Susan G. Komen Breast Cancer Foundation; Hollfelder foundation
• Investigators: Principal Investigator: Andrew Winokur, MD PhD, UConn Health

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: November 10, 2008
• First Submitted That Met QC Criteria: November 10, 2008
• First Posted (Estimate): November 13, 2008

Study Record Updates

• Last Update Posted (Actual): December 28, 2017
• Last Update Submitted That Met QC Criteria: December 4, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: cancer fatigue
• Additional Relevant MeSH Terms: Fatigue; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones; Thyrotropin-Releasing Hormone
• Other Study ID Numbers: 05-269-2; 601