- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00214305
Effects of Swallowing Therapy in Head and Neck Cancer
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Wisconsin
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Madison, Wisconsin, États-Unis, 53792
- University of Wisconsin
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Comparateur placebo: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
improved swallowing function
Délai: 1-month, 4-month, 6-month, and 12-month post treatment
|
1-month, 4-month, 6-month, and 12-month post treatment
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
significantly more oral intake
Délai: 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
Délai: 1-month, 4-month, 6-month, and 12-month post treatment
|
1-month, 4-month, 6-month, and 12-month post treatment
|
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less cost for medically needed services
Délai: 1-month, 4-month, 6-month, and 12-month post treatment
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1-month, 4-month, 6-month, and 12-month post treatment
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Diane Bless, MD, University of Wisconsin, Madison
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2003-373
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