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Dextromethorphan in Treating Patients With Fatigue Caused by Cancer
This study has been completed.
Sponsors and Collaborators: Cancer Institute of New Jersey
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00176540
  Purpose

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.


Condition Intervention
Fatigue
Unspecified Adult Solid Tumor, Protocol Specific
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: dextromethorphan hydrobromide

MedlinePlus related topics: Cancer
Drug Information available for: Dextromethorphan Dextromethorphan hydrobromide Levomethorphan Racemethorphan
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Open Label
Official Title: A Pilot Trial to Evaluate the Effects of Dextromethorphan in Patients Suffering From Cancer-Related Fatigue

Further study details as provided by National Cancer Institute (NCI):

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

Estimated Enrollment: 30
Study Start Date: March 2004
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

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00176540

Locations
United States, New Jersey
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States, 08690
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
Cancer Institute of New Jersey
Investigators
Principal Investigator: Susan Goodin, PharmD Cancer Institute of New Jersey
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000539650, CINJ-5017v2, CINJ-4598, CINJ-NJ11005
Study First Received: September 12, 2005
Last Updated: August 13, 2008
ClinicalTrials.gov Identifier: NCT00176540  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific
unspecified childhood solid tumor, protocol specific
fatigue

Study placed in the following topic categories:
Naphazoline
Oxymetazoline
Excitatory Amino Acids
Signs and Symptoms
Fatigue
Guaifenesin
Phenylephrine
Dextromethorphan
Phenylpropanolamine

Additional relevant MeSH terms:
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Excitatory Amino Acid Agents
Antitussive Agents
Central Nervous System Agents
Pharmacologic Actions
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on January 16, 2009