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Dextromethorphan in Treating Patients With Fatigue Caused by Cancer

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ClinicalTrials.gov Identifier: NCT00176540
Recruitment Status : Terminated (slow accrual)
First Posted : September 15, 2005
Last Update Posted : May 17, 2011
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Rutgers, The State University of New Jersey

Brief Summary:

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 or disease Intervention/treatment Phase
Fatigue Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific Drug: dextromethorphan hydrobromide Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Study Start Date : October 2003
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue
U.S. FDA Resources




Primary Outcome Measures :
  1. Efficacy

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


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

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

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 Posted: September 15, 2005    Key Record Dates
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