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| Sponsor: | University of Connecticut Health Center |
|---|---|
| Collaborators: |
Susan G. Komen Breast Cancer Foundation Hollfelder foundation |
| Information provided by: | University of Connecticut Health Center |
| 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) Drug: Placebo |
Phase II |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion criteria:
Contacts and Locations| United States, Connecticut | |
| University of Connecticut Health Center | |
| Farmington, Connecticut, United States, 06030 | |
| Principal Investigator: | Andrew Winokur, MD PhD | University of Connecticut Health Center |
More Information
| 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 |
|
cancer fatigue |
|
Fatigue Signs and Symptoms Hormones Thyrotropin-Releasing Hormone |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |