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

NCT00790296 | Terminated Phase 2 Results DMC

• 2 other identifiers: 05-269-2601
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer-related Fatigue

Keywords

cancer fatigue

Outcome Measures

Primary Outcomes (1)

• Change in Visual Analog Scale for Energy (VAS-E)Score From Baseline to 7 Hrs Post Study Medication Infusion

  1 to 100 scale with 1 referring to No Energy and 100 referring to Normal Energy.

  Baseline and 7 hours post study medication infusion

Study Arms (2)

Thyrotropin releasing hormone (TRH)

EXPERIMENTAL

TRH

Drug: Thyrotropin releasing hormone (TRH)

Saline

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Thyrotropin releasing hormone (TRH) DRUG

0.5mg and 1.5mg

Thyrotropin releasing hormone (TRH)

Placebo DRUG

Saline

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• UConn Health: lead
• Susan G. Komen Breast Cancer Foundation: collaborator
• Hollfelder foundation: collaborator

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

MeSH Terms

Interventions

Thyrotropin-Releasing Hormone

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Limitations and Caveats

Limitation: small sample size

Results Point of Contact

• Title: Andrew Winokur MD PhD
• Organization: University of Connecticut Health Center

awinokur@uchc.edu

860-679-6775

Study Officials

• Andrew Winokur, MD PhD

  UConn Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2008
• First Posted: November 13, 2008
• Study Start: December 1, 2006
• Primary Completion: February 1, 2010
• Study Completion: March 1, 2010
• Last Updated: December 28, 2017
• Results First Posted: May 3, 2011

Record last verified: 2017-12

Locations

US (1)