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Dextromethorphan in Treating Patients With Fatigue Caused by Cancer

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00176540
Enrollment
30
Registered
2005-09-15
Start date
2003-10-31
Completion date
2007-08-31
Last updated
2011-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

National Cancer Institute (NCI)
CollaboratorNIH
University of Medicine and Dentistry of New Jersey
Lead SponsorOTHER

Study design

Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 75 Years
Healthy volunteers
No

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

MeasureTime frame
Efficacy

Secondary

MeasureTime frame
Correlation of the changes in cancer-related fatigue with the levels of plasma homocysteine versus red blood cell folate

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026