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Evaluation of Synthetic Thyrotropin Releasing Hormone (TRH) as a Treatment for Cancer-Related Fatigue
This study is currently recruiting participants.
Verified by University of Connecticut, November 2008
Sponsors and Collaborators: University of Connecticut Health Center
Susan G. Komen Breast Cancer Foundation
Hollfelder foundation
Information provided by: University of Connecticut
ClinicalTrials.gov Identifier: NCT00790296
  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)
Other: Placebo
Phase II

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Thyrotropin Protirelin
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment, Safety/Efficacy Study
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 Breast or Prostate Cancer

Further study details as provided by University of Connecticut:

Primary Outcome Measures:
  • visual analog scale for energy (VAS-E) [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • hospital anxiety and depression scale (HADS) [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: December 2006
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Thyrotropin releasing hormone (TRH): Experimental
TRH
Drug: Thyrotropin releasing hormone (TRH)
0.5mg and 1.5mg
Saline: Placebo Comparator
Placebo
Other: 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 breast cancer or prostate cancer (maximum within 5 years of cancer diagnosis) who have recently undergone or are currently undergoing radiation therapy and who 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 breast cancer or prostate 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00790296

Contacts
Contact: Jayesh Kamath, MD PhD 860-679-6727 jkamath@uchc.edu
Contact: Andrew Winokur, MD PhD 860-679-6775 winokur@psychiatry.uchc.edu

Locations
United States, Connecticut
University of Connecticut Health Center Recruiting
Farmington, Connecticut, United States, 06030
Contact: Jayesh Kamath, MD PhD     860-679-6727     jkamath@uchc.edu    
Contact: Andrew Winokur, MD PhD     860-679-6775     winokur@psychiatry.uchc.edu    
Principal Investigator: Andrew Winokur, MD PhD            
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

Responsible Party: University of Connecticut Health Center ( Andrew Winokur MD PhD )
Study ID Numbers: 05-269-2, 601
Study First Received: November 10, 2008
Last Updated: November 10, 2008
ClinicalTrials.gov Identifier: NCT00790296  
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Connecticut:
cancer fatigue

Study placed in the following topic categories:
Signs and Symptoms
Fatigue
Prostatic Neoplasms
Thyrotropin-Releasing Hormone

Additional relevant MeSH terms:
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009