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

This study has been terminated.
(Interim analyses showed statistically and clinically significant results.)
Sponsor:
Collaborators:
Susan G. Komen Breast Cancer Foundation
Hollfelder foundation
Information provided by:
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00790296
First received: November 10, 2008
Last updated: April 5, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Cancer-related Fatigue
Drug: Thyrotropin releasing hormone (TRH)
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • Change in Visual Analog Scale for Energy (VAS-E)Score From Baseline to 7 Hrs Post Study Medication Infusion [ Time Frame: Baseline and 7 hours post study medication infusion ] [ Designated as safety issue: No ]
    1 to 100 scale with 1 referring to No Energy and 100 referring to Normal Energy.


Enrollment: 11
Study Start Date: December 2006
Study Completion Date: March 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Thyrotropin releasing hormone (TRH)
TRH
Drug: Thyrotropin releasing hormone (TRH)
0.5mg and 1.5mg
Placebo Comparator: Saline
Placebo
Drug: Placebo
Saline

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790296

Locations
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
University of Connecticut Health Center
Susan G. Komen Breast Cancer Foundation
Hollfelder foundation
Investigators
Principal Investigator: Andrew Winokur, MD PhD University of Connecticut Health Center
  More Information

No publications provided

Responsible Party: Andrew Winokur MD PhD, University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT00790296     History of Changes
Other Study ID Numbers: 05-269-2, 601
Study First Received: November 10, 2008
Results First Received: January 31, 2011
Last Updated: April 5, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Connecticut Health Center:
cancer fatigue

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms
Hormones
Thyrotropin-Releasing Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014