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Effects of Swallowing Therapy in Head and Neck Cancer

30. september 2015 oppdatert av: 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?

Studieoversikt

Detaljert 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.

Studietype

Intervensjonell

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Wisconsin
      • Madison, Wisconsin, Forente stater, 53792
        • University of Wisconsin

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

21 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

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: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.

Hva måler studien?

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

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Hovedetterforsker: Diane Bless, MD, University of Wisconsin, Madison

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 2005

Datoer for studieregistrering

Først innsendt

13. september 2005

Først innsendt som oppfylte QC-kriteriene

14. september 2005

Først lagt ut (Anslag)

21. september 2005

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

2. oktober 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. september 2015

Sist bekreftet

1. september 2015

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 2003-373

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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