Dextromethorphan in Treating Patients With Fatigue Caused by Cancer

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00176540
• Other study ID #: CDR0000539650
• Secondary ID: P30CA072720CINJ-
• Status: Terminated
• Phase: N/A
• First received: September 12, 2005
• Last updated: May 16, 2011
• Start date: October 2003
• Est. completion date: August 2007

Study information

• Verified date: May 2011
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 75 Years

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

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

Intervention

Drug:
• dextromethorphan hydrobromide

Locations

Country	Name	City	State
United States	Cancer Institute of New Jersey at Hamilton	Hamilton	New Jersey
United States	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy
Secondary	Correlation of the changes in cancer-related fatigue with the levels of plasma homocysteine versus red blood cell folate

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database