Dextromethorphan in Treating Patients With Fatigue Caused by Cancer

NCT00176540 | Terminated DMC

• 5 other identifiers: CDR0000539650P30CA072720CINJ-5017v2CINJ-4598CINJ-NJ11005
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Efficacy

Secondary Outcomes (1)

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

Interventions

dextromethorphan hydrobromide DRUG

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Cancer Institute of New Jersey at Hamilton

Hamilton, New Jersey, 08690, United States

Location

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

New Brunswick, New Jersey, 08903, United States

Location

Related Links

• Clinical trial summary from the National Cancer Institute's PDQ® database

MeSH Terms

Conditions

Fatigue

Interventions

Dextromethorphan

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Susan Goodin, PharmD, FCCP, BCOP

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: October 1, 2003
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: May 17, 2011

Record last verified: 2011-05

Locations

US (2)