Dextromethorphan in Treating Patients With Fatigue Caused by Cancer

This study has been terminated.
(slow accrual)
Sponsor:
Collaborator:
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00176540
First received: September 12, 2005
Last updated: May 16, 2011
Last verified: May 2011
  Purpose

RATIONALE: Dextromethorphan may help relieve fatigue in patients with cancer.

PURPOSE: This clinical trial is studying how well dextromethorphan works in treating patients with fatigue caused by cancer.


Condition Intervention
Fatigue
Unspecified Adult Solid Tumor, Protocol Specific
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: dextromethorphan hydrobromide

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Pilot Trial to Evaluate the Effects of Dextromethorphan in Patients Suffering From Cancer-Related Fatigue

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Efficacy

Secondary Outcome Measures:
  • Correlation of the changes in cancer-related fatigue with the levels of plasma homocysteine versus red blood cell folate

Estimated Enrollment: 30
Study Start Date: October 2003
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Assess the effects of dextromethorphan hydrobromide in patients with cancer-related fatigue.

Secondary

  • Correlate the changes in cancer-related fatigue with the levels of plasma homocysteine versus red blood cell folate.

OUTLINE: This is a multicenter, open-label, pilot study.

Patients receive oral dextromethorphan hydrobromide 3 times a day on days 1-7. Treatment repeats weekly for up to 3 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of malignancy

    • Must be undergoing active treatment for malignancy which may include hormonal therapy (e.g., tamoxifen citrate or leuprolide acetate), but not radiotherapy alone
  • Fatigue score ≥ 4 on a verbal analogue scale of 0 to 10
  • No untreated cancer-related anemia

PATIENT CHARACTERISTICS:

  • Hemoglobin > 10 g/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to swallow pills
  • No known allergy to dextromethorphan hydrobromide
  • No patients known to be phenotypically poor metabolizers of CYP2D6
  • No untreated hypothyroidism

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Prior single-dose inhibitors (e.g., ranitidine or cimetidine) for hypersensitivity prophylaxis allowed
  • Erythropoietic growth factor therapy of > 8 weeks duration allowed
  • No concurrent CYP2D6 inducers or inhibitors
  • No concurrent monoamine oxidase inhibitors
  • No other concurrent medications containing dextromethorphan hydrobromide
  • No concurrent over-the-counter medication, herbal product, vitamin, food supplement, or any other type of special product unless permission to continue use is obtained from the Principal Investigator
  • No other concurrent anticancer investigational agents or therapies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00176540

Locations
United States, New Jersey
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States, 08690
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Investigators
Principal Investigator: Susan Goodin, PharmD, FCCP, BCOP Rutgers Cancer Institute of New Jersey
  More Information

Additional Information:
No publications provided

Responsible Party: Susan Goodin, MD, UMDNJ/CINJ
ClinicalTrials.gov Identifier: NCT00176540     History of Changes
Other Study ID Numbers: CDR0000539650, P30CA072720, CINJ-5017v2, CINJ-4598, CINJ-NJ11005
Study First Received: September 12, 2005
Last Updated: May 16, 2011
Health Authority: United States: Federal Government

Keywords provided by Rutgers, The State University of New Jersey:
unspecified adult solid tumor, protocol specific
unspecified childhood solid tumor, protocol specific
fatigue

Additional relevant MeSH terms:
Fatigue
Neoplasms
Signs and Symptoms
Dextromethorphan
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antitussive Agents
Central Nervous System Agents
Therapeutic Uses
Respiratory System Agents

ClinicalTrials.gov processed this record on April 22, 2014