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Investigating the Prevalence and Prognostic Importance of Polypharmacy in Adults Treated for Newly Diagnosed Acute Myelogenous Leukemia (AML)

29. juni 2018 oppdatert av: Wake Forest University Health Sciences
Prevalence and prognostic significance of polypharmacy has not been evaluated in adults undergoing treatment for AML. Investigating the significance of polypharmacy in this population may help improve patient assessment and provide an opportunity to design simple interventions to minimize unnecessary morbidity associated with treatment.

Studieoversikt

Status

Fullført

Intervensjon / Behandling

Detaljert beskrivelse

The incidence of acute myelogenous leukemia (AML) increases with age. Older AML patients, generally defined by age 60 years and above, have worse treatment outcomes than younger patients. While selected older patients can benefit from standard therapies, as a group they experience increased treatment-related toxicity, decreased remission rates, decreased disease-free survival and decreased overall survival. Outcome disparity is in part explained by age related biologic features. Older patients are more likely to present with unfavorable cytogenetic abnormalities, multidrug resistance phenotypes, and secondary AML. However, even older adults with favorable tumor biology have a worse prognosis compared to younger patients. Patient-specific factors including impaired physical function and comorbidity independently predict increased treatment toxicity and decreased survival. Improving patient assessment strategies is critical to identify those patients who are most likely to benefit from induction and post-remission therapies.

Treatment decision-making for older adults is hampered by the difficulty of accurately predicting vulnerability to toxicity. Increasing age alone is a risk factor for poor response to therapy. Older adults of the same chronologic age represent a heterogeneous population. Multiple patient-specific factors may impact an older adult's ability to tolerate tumor burden and treatments. Comorbid disease, functional status and cognitive status are examples of factors that reflect an individual patient's reserve capacity; none of these can be adequately assessed with chronologic age alone.

Translating geriatric assessment strategies into the evaluation of older patients with acute leukemia should help refine the treatment approach to this population. One strategy commonly used in geriatric medicine is the comprehensive geriatric assessment (CGA). CGA refers to a multidisciplinary evaluation of geriatric domains, including comorbid disease, physical function, cognitive function, psychological state, nutritional status, and medication management. In older cancer patients CGA can identify problems that may interfere with cancer treatment and is recommended by the NCCN Guidelines for "Senior Adult Oncology". The optimal measures to use and how to change management based on results are less clear.

Medication management may be of particular importance for older adults with AML due to the potentially high prevalence of polypharmacy in this population. Studies of older adults with cancer report average numbers of medications ranging from 4-9. These numbers may be higher for patients being actively treated for acute leukemia. Polypharmacy is associated with increased adverse drug reactions and increased risk of drug-drug interactions. Careful medication review with discontinuation of potentially unnecessary or inappropriate medications may minimize negative consequences of polypharmacy.

To date, however, prevalence and prognostic significance of polypharmacy has not been evaluated in adults undergoing treatment for AML. Investigating the significance of polypharmacy in this population may help improve patient assessment and provide an opportunity to design simple interventions to minimize unnecessary morbidity associated with treatment.

Studietype

Observasjonsmessig

Registrering (Faktiske)

209

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

60 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Adults age ≥60 who received treatment while hospitalized for AML

Beskrivelse

Inclusion Criteria:

  • Hospitalized between January 2004 and December 2009 with newly diagnosed AML
  • Age ≥60 years at the time of diagnosis
  • Received treatment while hospitalized for AML

Exclusion Criteria:

  • 30-day mortality data unavailable

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Kohort
  • Tidsperspektiver: Retrospektiv

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prevalence of polypharmacy in adults ≥60 years of age hospitalized for treatment of newly diagnosed AML
Tidsramme: Day 1 (admission)
Number of medications at baseline
Day 1 (admission)
Prevalence of polypharmacy in adults ≥60 years of age hospitalized for treatment of newly diagnosed AML
Tidsramme: Through hospitilization, an average of 30 days
Number of medications at discharge
Through hospitilization, an average of 30 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. august 2010

Primær fullføring (Faktiske)

1. april 2014

Studiet fullført (Faktiske)

1. november 2014

Datoer for studieregistrering

Først innsendt

19. januar 2016

Først innsendt som oppfylte QC-kriteriene

21. januar 2016

Først lagt ut (Anslag)

26. januar 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. juli 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. juni 2018

Sist bekreftet

1. juni 2018

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • IRB00014134
  • CCCWFU 22410 (Annen identifikator: Wake Forest University Health Sciences)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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