- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
New Jersey
-
Hamilton, New Jersey, Forente stater, 08690
- Cancer Institute of New Jersey At Hamilton
-
New Brunswick, New Jersey, Forente stater, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Masking: Ingen (Open Label)
Hva måler studien?
Primære resultatmål
Resultatmål |
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Effektivitet
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Sekundære resultatmål
Resultatmål |
|---|
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Correlation of the changes in cancer-related fatigue with the levels of plasma homocysteine versus red blood cell folate
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Susan Goodin, PharmD, FCCP, BCOP, Rutgers Cancer Institute of New Jersey
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CDR0000539650
- P30CA072720 (U.S. NIH-stipend/kontrakt)
- CINJ-5017v2
- CINJ-4598
- CINJ-NJ11005
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