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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) 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 2010 |
| Estimated Primary Completion Date: | June 2010 (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 |
Inclusion Criteria:
Exclusion criteria:
Contacts and Locations| 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 |
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: | May 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00790296 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
cancer fatigue |
|
Signs and Symptoms Fatigue Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Hormones Pharmacologic Actions Thyrotropin-Releasing Hormone |