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Randomized Comparison of Low and Conventional Irradiance PDT for Skin Cancer

12. desember 2018 oppdatert av: Sally Ibbotson

A Randomized Assessor-blinded Comparison of Low Irradiance and Conventional Irradiance Photodynamic Therapy (PDT) for Superficial Non-melanoma Skin Cancer

This study aims to examine whether the pain of topical photodynamic therapy (PDT) is significantly different when using low irradiance ambulatory light emitting diode (LED) devices compared with conventional higher irradiance hospital based LED light sources when used for superficial non-melanoma skin cancer. The investigators are also investigating the phototoxicity and efficacy of each regime in this randomized assessor-blinded clinical trial.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

A randomized assessor-blinded comparative study of low irradiance ambulatory LED devices with conventional hospital-based LED devices for superficial non-melanoma skin cancer. Preliminary observations suggest that low irradiance LEDs cause less pain but are as effective, so the investigators are examining this in a clinical trial of patients with lesions </= 2cm diameter of non-melanoma skin cancer (Bowen's disease and superficial basal cell carcinoma). Patients with these conditions referred to the PDT clinic will be invited to participate and if they are eligible and consent to treatment then they will be prospectively randomized to either ambulatory PDT or conventional PDT. Pain and phototoxicity scores will be recorded and clinical efficacy will be assessed up to one year after the last treatment. Computer-generated block randomization will be performed and at 90% power to detect as significant at the 5% level a mean difference in pain score of 2 in one group compared with 4 in the other, 36 patients will be needed, and as the participants will often be elderly and frail the investigators will aim for a safety margin of recruiting 50 participants to account for drop-outs. Participants will receive two treatments of either arm at a one week interval and will be assessed clinically at three months and if residual disease remains then the two treatments a week apart are repeated. Pain assessed using a visual analogue scale (VAS) score and phototoxicity on a semi-quantitative scale are recorded at 7 days when the participant returns for their second treatment. Follow up for clinical assessment is at 6 months and one year after treatment. Participants also give their opinion of treatment at one year follow up. Assessors of adverse effects and efficacy will be blinded. Data recording and analysis will be undertaken by the study statistician Dr Robert Dawe and analysis will be on an intention to treat basis using appropriate statistical tests comparing the pre-planned outcome measures, with pain as primary outcome and outcome, efficacy and patient satisfaction as secondary outcomes

Studietype

Intervensjonell

Registrering (Faktiske)

50

Fase

  • Ikke aktuelt

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

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Bowen's disease or superficial basal cell carcinoma referred for PDT and lesion not greater than 2.4cm diameter

Exclusion Criteria:

  • Unable to give consent, >2cm diameter, lesions on highly curved surfaces where ambulatory device would not adhere

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: low irradiance LED PDT
Ambulight LED portable PDT treatment
Enhet: Ambulight (Ambicare Health)
battery-operated low irradiance red light LED ("skin cancer plaster")
Aktiv komparator: conventional higher irradiance LED
Conventional LED hospital based standard PDT treatment
Enhet: Ambulight (Ambicare Health)
battery-operated low irradiance red light LED ("skin cancer plaster")

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pain on VAS Score
Tidsramme: one week after treatment
assess on visual analogue scale (VAS) score of 0 - 10cm, with 0 representing no pain experienced through to 10 representing the worst pain imaginable. The participant marks across a 0-10cm unmarked line where their level of pain experience is and this is measured eg. 2cm if experiencing mild pain or 8.5cm which would represent severe pain
one week after treatment

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Phototoxicity
Tidsramme: one week after treatment

erythema, oedema, blistering, crusting, ulceration on semi-quantitative scale. Erythema is graded as 0 = absent, 1 = mild, 2 = moderate or 3 = severe erythema as assessed by naked eye examination. Oedema is graded as 0 = absent or 1 = present. Likewise crusting or ulceration are each graded as 0 = absent and 1 = present by naked eye examination. Data will be presented and analysed separately ie. erythema data will be presented and then separately whether oedema, crusting or ulceration are present or absent.

ie. reporting may appear as example: erythema score 3 of range of 0-3 options; oedema score 1 (binary option of 0 or 1); crusting score 0 (binary option of 0 or 1); ulceration score 0 (binary option of 0 or 1)
one week after treatment
Clinical Clearance of Lesion
Tidsramme: 12 months after treatment
clinical assessment by study dermatologist to determine by inspection and palpation whether the lesion is clear, partially clear or not clear - assessed at 3, 6 and 12 months after treatment, with 12 months as the final study outcome endpoint analysed
12 months after treatment
Patient Satisfaction
Tidsramme: one year after treatment - last visit

brief patient questionnaire to evaluate their opinion of the treatment they received. This is assessed as A.efficacy of treatment - 1 = not effective NR; 2 = partIally effective PR; 3 = completely effective CR; B.Side effects of treatment eg. pain and inflammation - 1 = severe; 2 = moderate; 3 = mild; 4 = none/minimal. C.Practicalities of treatment eg. ease of use, travel, time, inconvenience - 1 = very disruptive and difficult; 2 = moderately disruptive and difficult; 3 = minimally disruptive and difficult. The scores of A, B and C will be added to give an overall score with range of overall minimum score option 3 and maximum 10.

Patients will also separately be asked to give overall evaluation on a VAS scale of 0 = treatment very poor and would not have again through to 10 = treatment excellent and I would have again - with a continuous line option from 0 - 10 to mark across, providing a separate score with range options 0 to 10
one year after treatment - last visit

Samarbeidspartnere og etterforskere

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

Sponsor

Sally Ibbotson

Etterforskere

  • Hovedetterforsker: Sally H Ibbotson, MD, University of Dundee

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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. oktober 2011

Primær fullføring (Faktiske)

6. februar 2017

Studiet fullført (Faktiske)

6. februar 2017

Datoer for studieregistrering

Først innsendt

5. august 2016

Først innsendt som oppfylte QC-kriteriene

15. august 2016

Først lagt ut (Anslag)

19. august 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. januar 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. desember 2018

Sist bekreftet

1. desember 2018

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2011DS04

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Ja

IPD-planbeskrivelse

peer reviewed publications and presentations at international and national meetings

IPD-delingstidsramme

presenting study data at British Association of Dermatologists annual meeting Edinburgh 5.7.18 and abstract will be published in Br J Dermatol and full publication will follow

Tilgangskriterier for IPD-deling

via presentation and publication in peer-reviewed journal

IPD-deling Støtteinformasjonstype

  • Studieprotokoll
  • Statistisk analyseplan (SAP)
  • Informert samtykkeskjema (ICF)
  • Klinisk studierapport (CSR)

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. .

Kliniske studier på Ikke-melanom hudkreft

Kliniske studier på Ambulight (Ambicare Health)

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