Dextromethorphan in Treating Patients With Fatigue Caused by Cancer
NCT ID: NCT00176540
Last Updated: 2011-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
30 participants
INTERVENTIONAL
2003-10-31
2007-08-31
Brief Summary
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PURPOSE: This clinical trial is studying how well dextromethorphan works in treating patients with fatigue caused by cancer.
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Detailed Description
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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.
Conditions
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Study Design
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SUPPORTIVE_CARE
NONE
Interventions
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dextromethorphan hydrobromide
Eligibility Criteria
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Inclusion Criteria
* 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
12 Years
75 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Medicine and Dentistry of New Jersey
OTHER
Responsible Party
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UMDNJ/CINJ
Principal Investigators
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Susan Goodin, PharmD, FCCP, BCOP
Role: PRINCIPAL_INVESTIGATOR
Rutgers Cancer Institute of New Jersey
Locations
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Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Countries
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Related Links
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Clinical trial summary from the National Cancer Institute's PDQ® database
Other Identifiers
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CINJ-5017v2
Identifier Type: -
Identifier Source: secondary_id
CINJ-4598
Identifier Type: -
Identifier Source: secondary_id
CINJ-NJ11005
Identifier Type: -
Identifier Source: secondary_id
CDR0000539650
Identifier Type: -
Identifier Source: org_study_id
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