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Effects of Swallowing Therapy in Head and Neck Cancer

30. september 2015 opdateret af: University of Wisconsin, Madison
Treatment for head and neck cancer often results in significant swallowing problems because of reduced range of motion (ROM) of the larynx, tongue base, and pharyngeal walls. Our question is: Is swallowing therapy to improve ROM during swallowing maneuvers efficacious in patients with reduced ROM?

Studieoversigt

Detaljeret beskrivelse

Patients with head and neck cancer who are treated with chemoradiation and/or surgical resection may exhibit a variety of swallowing difficulties due to reduced range of motion (ROM) resulting from absence or alteration of the structures involved in deglutition. Chemoradiation protocols have been receiving increased attention in the treatment of head and neck cancer. The primary focus of these regimens is disease control and organ sparing. Preservation of oropharyngeal anatomy, however, has not equated with preservation of function. Due to the severity and frequency of swallowing problems in this population, it is critical that the effectiveness of dysphagia (i.e. swallowing disorder) rehabilitation protocols on preservation and/or restoration of function be determined. In the absence of potential remediation, patients may reject organ preservation treatment protocols because of negative functional side effects. There have been a number of therapeutic exercises designed to improve swallowing that have been shown to have a positive effect on head and neck cancer patients who are dysphagic as a result of treatment with surgery and/or chemoradiation. The short- and long-term effectiveness of these exercises has not been defined. The purpose of this study is to compare the effectiveness of combined ROM and postural sensory therapy for swallowing dysfunction to postural sensory therapy alone. By maximizing the effectiveness of therapy, it is expected that improved swallowing function will translate into better quality of life through enjoyment of meals and improved nutrition and hydration so critical to the health and sense of well being of individuals recovering from head and neck cancer.

To be included, subjects must be between 21 and 80 years old and have undergone treatment for the head and neck cancer in the form of chemoradiation, and/or one of the following specific types of head and neck cancer surgery: supraglottic laryngectomy, anterior resection with primary or skin graft closure, anterior resection with distal or free flap closure, posterior resection with primary or skin graft closure, or posterior resection with distal or free flap. Potential subjects must have been diagnosed with Stage I-IV disease and also be available for twice-weekly swallowing therapy sessions. Furthermore, subjects must be available for 12 months while on study.

No subject will be included who has any history of other medical problems that may affect swallowing, speech, voice, neurological problems, gastroenterological problems, or other health problems as determined by the patient's physician and the investigators. Patients with prior treated cancer of the head and neck, or who received a total laryngectomy operation are also not eligible.

Undersøgelsestype

Interventionel

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792
        • University of Wisconsin

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

21 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Subject have undergone treatment for the head and neck cancer in the form of chemoradiation, and/or one of the following specific types of head and neck cancer surgery: supraglottic laryngectomy, anterior resection with primary or skin graft closure, anterior resection with distal or free flap closure, posterior resection with primary or skin graft closure, or posterior resection with distal or free flap
  • Potential subjects must have been diagnosed with Stage I-IV disease

Exclusion Criteria:

  • history of medical problems that may affect swallowing, speech, voice
  • neurological problems
  • gastroenterological problems
  • prior treatment for cancer of the head and neck
  • patient who received a total laryngectomy

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Range of Motion Therapy Program
The program involves exercises and maneuvers that include voluntary maximal movements of the tongue, pitch range exercises, head lifting (Shaker exercise), resistance to laryngeal excursion (Mendelsohn Maneuver), breath holding after swallow and cough, thermal-tactile stimulation (ice), suck-swallow, optimal posturing, and dietary changes.
The program involves exercises and maneuvers that include voluntary maximal movements of the tongue, pitch range exercises, head lifting (Shaker exercise), resistance to laryngeal excursion (Mendelsohn Maneuver), breath holding after swallow and cough, thermal-tactile stimulation (ice), suck-swallow, optimal posturing, and dietary changes.
Placebo komparator: Postural Sensory Therapy Program
The program involves all of the above, except that range of motion exercises (voluntary maximal movements of the tongue, pitch range exercises, head lifting, resistance to laryngeal excursion, breath holding after swallow and cough) are not performed.
The program involves all of the above, except that range of motion exercises (voluntary maximal movements of the tongue, pitch range exercises, head lifting, resistance to laryngeal excursion, breath holding after swallow and cough) are not performed.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
improved swallowing function
Tidsramme: 1-month, 4-month, 6-month, and 12-month post treatment
1-month, 4-month, 6-month, and 12-month post treatment

Sekundære resultatmål

Resultatmål
Tidsramme
significantly more oral intake
Tidsramme: 1-month, 4-month, 6-month, and 12-month post treatment
1-month, 4-month, 6-month, and 12-month post treatment
a less restricted diet
Tidsramme: 1-month, 4-month, 6-month, and 12-month post treatment
1-month, 4-month, 6-month, and 12-month post treatment
less cost for medically needed services
Tidsramme: 1-month, 4-month, 6-month, and 12-month post treatment
1-month, 4-month, 6-month, and 12-month post treatment

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Diane Bless, MD, University of Wisconsin, Madison

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. august 2005

Datoer for studieregistrering

Først indsendt

13. september 2005

Først indsendt, der opfyldte QC-kriterier

14. september 2005

Først opslået (Skøn)

21. september 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

2. oktober 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. september 2015

Sidst verificeret

1. september 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2003-373

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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