Dextromethorphan in Treating Patients With Fatigue Caused by Cancer

• Status: Terminated
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Medicine and Dentistry of New Jersey
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dextromethorphan

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