Dextromethorphan in Treating Patients With Fatigue Caused by Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Trial to Evaluate the Effects of Dextromethorphan in Patients Suffering From Cancer-Related Fatigue

Conditions
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Fatigue, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: dextromethorphan hydrobromide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: dextromethorphan hydrobromide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of the changes in cancer-related fatigue with the levels of plasma homocysteine versus red blood cell folate |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific, unspecified childhood solid tumor, protocol specific, fatigue