- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00176540
Dextromethorphan in Treating Patients With Fatigue Caused by Cancer
A Pilot Trial to Evaluate the Effects of Dextromethorphan in Patients Suffering From Cancer-Related Fatigue
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
New Jersey
-
Hamilton, New Jersey, Forenede Stater, 08690
- Cancer Institute of New Jersey At Hamilton
-
New Brunswick, New Jersey, Forenede Stater, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
|---|
|
Effektivitet
|
Sekundære resultatmål
Resultatmål |
|---|
|
Correlation of the changes in cancer-related fatigue with the levels of plasma homocysteine versus red blood cell folate
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Susan Goodin, PharmD, FCCP, BCOP, Rutgers Cancer Institute of New Jersey
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CDR0000539650
- P30CA072720 (U.S. NIH-bevilling/kontrakt)
- CINJ-5017v2
- CINJ-4598
- CINJ-NJ11005
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