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Sponsors and Collaborators: |
University of Connecticut Health Center Susan G. Komen Breast Cancer Foundation Hollfelder foundation |
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Information provided by: | University of Connecticut |
ClinicalTrials.gov Identifier: | NCT00790296 |
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 |
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Cancer-Related Fatigue |
Drug: Thyrotropin releasing hormone (TRH) Other: Placebo |
Phase II |
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 |
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 |
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Thyrotropin releasing hormone (TRH): Experimental
TRH
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Drug: Thyrotropin releasing hormone (TRH)
0.5mg and 1.5mg
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Saline: Placebo Comparator
Placebo
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Other: Placebo
Saline
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion criteria:
Contact: Jayesh Kamath, MD PhD | 860-679-6727 | jkamath@uchc.edu |
Contact: Andrew Winokur, MD PhD | 860-679-6775 | winokur@psychiatry.uchc.edu |
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 |
Principal Investigator: | Andrew Winokur, MD PhD | University of Connecticut Health Center |
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 |
cancer fatigue |
Signs and Symptoms Fatigue Prostatic Neoplasms Thyrotropin-Releasing Hormone |
Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Pharmacologic Actions |