Clinical trial NCT00176540: 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
Overall status: TERMINATED
Phase: NA
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
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-09-15
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Efficacy
Secondary outcomes:
measure: Correlation of the changes in cancer-related fatigue with the levels of plasma homocysteine versus red blood cell folate
Other outcomes:
Locations:
city: Hamilton
country: United States
facility: Cancer Institute of New Jersey at Hamilton
state: New Jersey
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Susan Goodin, PharmD, FCCP, BCOP
role: PRINCIPAL_INVESTIGATOR
References: