Fatigue, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified adult solid tumor, protocol specific, unspecified childhood solid tumor, protocol specific, fatigue
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.
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlation of the changes in cancer-related fatigue with the levels of plasma homocysteine versus red blood cell folate | — |
Countries
United States