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

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ClinicalTrials.gov Identifier: NCT00790296
Recruitment Status : Terminated (Interim analyses showed statistically and clinically significant results.)
First Posted : November 13, 2008
Results First Posted : May 3, 2011
Last Update Posted : December 28, 2017
Sponsor:
Collaborators:
Susan G. Komen Breast Cancer Foundation
Hollfelder foundation
Information provided by (Responsible Party):
UConn Health

Study Description
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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.


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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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
Study Start Date : December 2006
Actual Primary Completion Date : February 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue Hormones
Drug Information available for: Protirelin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Thyrotropin releasing hormone (TRH)
TRH
 Drug: Thyrotropin releasing hormone (TRH)
0.5mg and 1.5mg
Placebo Comparator: Saline
Placebo
 Drug: Placebo
Saline


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    1 to 100 scale with 1 referring to No Energy and 100 referring to Normal Energy.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00790296


Locations
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United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
UConn Health
Susan G. Komen Breast Cancer Foundation
Hollfelder foundation
Investigators
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Principal Investigator: Andrew Winokur, MD PhD UConn Health
More Information
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Responsible Party: UConn Health
ClinicalTrials.gov Identifier: NCT00790296    
Other Study ID Numbers: 05-269-2
601
First Posted: November 13, 2008    Key Record Dates
Results First Posted: May 3, 2011
Last Update Posted: December 28, 2017
Last Verified: December 2017
Keywords provided by UConn Health:
cancer fatigue
Additional relevant MeSH terms:
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Fatigue
Hormones
Thyrotropin-Releasing Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs