Dextromethorphan in Treating Patients With Fatigue Caused by Cancer

Not Applicable

Terminated

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

• Registration Number: NCT00176540
• Lead Sponsor: University of Medicine and Dentistry of New Jersey

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.

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-16
• Last Update Posted: 2011-05-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy

Secondary Outcome Measures

Name	Time	Method
Correlation of the changes in cancer-related fatigue with the levels of plasma homocysteine versus red blood cell folate

Trial Locations

Locations (2)

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School; 🇺🇸 New Brunswick, New Jersey, United States

Cancer Institute of New Jersey at Hamilton; 🇺🇸 Hamilton, New Jersey, United States