Dextromethorphan in Treating Patients With Fatigue Caused by Cancer

University of Medicine and Dentistry of New Jersey

Status: Terminated

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

Treatments: Drug: dextromethorphan hydrobromide

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00176540

P30CA072720 (U.S. NIH Grant/Contract)

CINJ-NJ11005

CINJ-4598

CINJ-5017v2

CDR0000539650

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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