search
Back to results

Dextromethorphan in Treating Patients With Fatigue Caused by Cancer

Primary Purpose

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

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
dextromethorphan hydrobromide
Sponsored by
University of Medicine and Dentistry of New Jersey
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fatigue focused on measuring unspecified adult solid tumor, protocol specific, unspecified childhood solid tumor, protocol specific, fatigue

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Institute of New Jersey at Hamilton
  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

Outcomes

Primary Outcome Measures

Efficacy

Secondary Outcome Measures

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

Full Information

First Posted
September 12, 2005
Last Updated
May 16, 2011
Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00176540
Brief Title
Dextromethorphan in Treating Patients With Fatigue Caused by Cancer
Official Title
A Pilot Trial to Evaluate the Effects of Dextromethorphan in Patients Suffering From Cancer-Related Fatigue
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Terminated
Why Stopped
slow accrual
Study Start Date
October 2003 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Masking
None (Open Label)
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
dextromethorphan hydrobromide
Primary Outcome Measure Information:
Title
Efficacy
Secondary Outcome Measure Information:
Title
Correlation of the changes in cancer-related fatigue with the levels of plasma homocysteine versus red blood cell folate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Goodin, PharmD, FCCP, BCOP
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute of New Jersey at Hamilton
City
Hamilton
State/Province
New Jersey
ZIP/Postal Code
08690
Country
United States
Facility Name
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States

12. IPD Sharing Statement

Links:
URL
http://clinicaltrials.gov/ct2/show/NCT00176540
Description
Clinical trial summary from the National Cancer Institute's PDQ® database

Learn more about this trial

Dextromethorphan in Treating Patients With Fatigue Caused by Cancer

We'll reach out to this number within 24 hrs