Trials Sponsors Conditions Drugs Pricing

Conditions

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

Keywords

unspecified adult solid tumor, protocol specificunspecified childhood solid tumor, protocol specificfatigue

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 hydrobromideDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age12 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (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

Sponsors & Collaborators

University of Medicine and Dentistry of New Jersey
Otherlead
National Cancer Institute (NCI)
NIHcollaborator

Study Sites (2)

Cancer Institute of New Jersey at Hamilton

Hamilton, New Jersey, 08690, United States

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

New Brunswick, New Jersey, 08903, United States

MeSH Terms

Conditions

Fatigue

Interventions

Dextromethorphan

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenes

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 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

August 2007

Actual (reported)

Study Stopped

Dextromethorphan in Treating Patients With Fatigue Caused by Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (2)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (2)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations