Status:
TERMINATED
Dextromethorphan in Treating Patients With Fatigue Caused by Cancer
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Fatigue
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
12-75 years
Phase:
NA
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 canc...
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 pl...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00176540
Start Date
October 1 2003
End Date
August 1 2007
Last Update
May 17 2011
Active Locations (2)
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1
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States, 08690
2
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903