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Swallowing Rehabilitation in Patients With Head and Neck Cancer Receiving Radiotherapy (ReDyOR)

18. september 2020 opdateret af: Esther Marco Navarro, Parc de Salut Mar

Effects of Prophylactic Swallowing Exercises on Dysphagia and Quality of Life in Patients With Head and Neck Cancer Receiving Radiotherapy: A Randomized Clinical Trial

Head and neck cancer has a negative impact in swallowing function and quality of life. Rehabilitation has proven its usefulness after radiation therapy (RT), but some studies suggest that interventions should be initiated prior to RT sessions. This study aims to evaluate the effects of prophylactic rehabilitation on swallowing and quality of life. The study pretends to establish a preventive rehabilitative program with the target of reducing RT side effects and improve patients' quality of life.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Head and neck cancer has a negative impact in swallowing function and quality of life. Although current diagnostic and therapeutic protocols try to preserve swallowing and speaking, acute or late dysphagia as well as a poor quality of life are frequent in these patients.

Some studies have reported an improvement in swallowing function after an exercise based intervention following radiation therapy (RT), regardless the need of concomitant chemotherapy (RT-QT). Other studies focus the interest in the use of prophylactic exercises to prevent or minimize post-swallowing dysfunction.

Patients receiving RT or RT-QT refer worsening of their quality of life, especially during the first days after treatment. One study suggests that rehabilitation prior to cancer treatment could potentially improve quality of life. However, this observation should be contrasted with a randomized study.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

52

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Spanien
      • Barcelona, Spanien, 08024
        • Hospital de l'Esperança

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients with advanced head and neck cancer receiving radiotherapy

Exclusion Criteria:

  • Candidates to surgical treatment
  • Previous head and neck cancer
  • Dysphagia due to causes other than cancer
  • Previous head or neck radiation therapy.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Early rehabilitation
Early intervention consisting in standard swallow therapy and instructions to train respiratory muscles starting 2 weeks before Radiotherapy during 6 months
Andet: Early rehabilitation

Early swallowing exercises and respiratory muscle training: Standard swallow therapy and instructions for training submental muscles involved in swallowing function and expiratory strength starting 2 weeks before radiotherapy

Expiratory/Inspiratory training: the training load is the maximum inspiratory/expiratory load defined according to patient tolerance. This load will be equivalent to 10 maximal repetitions (RM) as 10 consecutive inspirations (x 5 sessions), three times a day.

All sessions will be conducted under the supervision of an expert physiotherapist/swallowing therapist. The total duration of the training program is 6 months.
Aktiv komparator: Later rehabilitation
Late intervention consists of standard swallow therapy and instructions to train respiratory muscles starting after completing Radiotherapy
Andet: Late rehabilitation
Late swallowing exercises and respiratory muscle training: Standard swallow therapy and instructions for training submental muscles involved in swallowing function and expiratory strength starting after completing radiotherapy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in dysphagia severity at three months post radiotherapy
Tidsramme: 2 weeks before beginning radiotherapy, and 3 months after completing radiotherapy
8-point Penetration Aspiration Scale: scores of 1-2 indicate normal swallowing, 3-5 reflect penetration, and >6, aspiration
2 weeks before beginning radiotherapy, and 3 months after completing radiotherapy
Change in quality of life at three months post radiotherapy
Tidsramme: 2 weeks before beginning radiotherapy and 3 months after completing radiotherapy
Head & Neck Cancer 35 (HN35)
2 weeks before beginning radiotherapy and 3 months after completing radiotherapy

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in dysphagia security signs at three months post radiotherapy
Tidsramme: 2 weeks before beginning radiotherapy and 3 months after completing radiotherapy
Security signs (tone of voice, coughing during or after eating, or desaturation of more than 3% compared to baseline pulse oximetry) assessed with the Volume Viscosity Swallow Test
2 weeks before beginning radiotherapy and 3 months after completing radiotherapy
Change in lingual Force at three months post radiotherapy
Tidsramme: 2 weeks before beginning radiotherapy and 3 months after completing radiotherapy
Lingual Force: maximum isometric tongue pressure of three peak isometric tongue pressure scores assessed with the IOPI system.
2 weeks before beginning radiotherapy and 3 months after completing radiotherapy

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Parc de Salut Mar

Samarbejdspartnere

Asociación Española contra el Cáncer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2016

Primær færdiggørelse (Faktiske)

1. april 2020

Studieafslutning (Faktiske)

1. maj 2020

Datoer for studieregistrering

Først indsendt

15. februar 2016

Først indsendt, der opfyldte QC-kriterier

9. september 2016

Først opslået (Skøn)

14. september 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. september 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. september 2020

Sidst verificeret

1. september 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2014/5707/l

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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