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Dextromethorphan in Treating Patients With Fatigue Caused by Cancer

This study has been terminated.
(slow accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00176540
First Posted: September 15, 2005
Last Update Posted: May 17, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Rutgers, The State University of New Jersey
  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: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 of New Jersey
National Cancer Institute (NCI)
Investigators
Principal Investigator: Susan Goodin, PharmD, FCCP, BCOP Rutgers Cancer Institute of New Jersey
  More Information

Additional Information:
Responsible Party: Susan Goodin, MD, UMDNJ/CINJ
ClinicalTrials.gov Identifier: NCT00176540     History of Changes
Other Study ID Numbers: CDR0000539650
P30CA072720 ( U.S. NIH Grant/Contract )
CINJ-5017v2
CINJ-4598
CINJ-NJ11005
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: May 17, 2011
Last Verified: May 2011

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:
Neoplasms
Fatigue
Signs and Symptoms
Dextromethorphan
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs