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


N/A
12 Years
75 Years
Not Enrolling
Both
Fatigue, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific

Thank you

Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Efficacy

Principal Investigator

Susan Goodin, PharmD, FCCP, BCOP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute of New Jersey

Authority:

United States: Federal Government

Study ID:

CDR0000539650

NCT ID:

NCT00176540

Start Date:

October 2003

Completion Date:

August 2007

Related Keywords:

  • Fatigue
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • unspecified childhood solid tumor, protocol specific
  • fatigue
  • Fatigue
  • Neoplasms

Name

Location

Cancer Institute of New Jersey at HamiltonHamilton, New Jersey  08690
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903