Laryngectomy
Conditions
Interventions
The selected patients were randomly randomized in blocks of 4, into two groups: Control and Intervention. The study is blinded in 2 moments, the first one where patients and researchers do not know in
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Sponsors
Instituto Nacional do Câncer - INCA
Instituto Nacional do Câncer - INCA
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients from the Head and Neck Sector of INCA will be included. They performed all oncological treatment at the institution. Undergoing partial laryngectomy reconstructed with CHEP; with or without adjuvant radiotherapy. Who concluded radiotherapy at least 6 months ago until the moment of the speech therapy intervention of the study. Patients capable of carrying out the strategies requested for the study on their own; both physically and cognitively. Available to come to consultations once every two weeks for clinical evaluation, monitoring of exercise performance and guidance on proper execution at home.
Exclusion criteria
Exclusion criteria: Are using any other alternative feeding route. Previously diagnosed central or peripheral neurological alteration that interferes with the swallowing function. Surgical or oncological intervention during the period of speech therapy intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected primary outcome; To evaluate the effects of the shaker maneuver on the swallowing dynamics of patients undergoing OPHL Type IIa.;Primary outcome found; The group that started the protocol with the placebo protocol had dysphagia classified in 32.10% at level 4; 48.30% at level 5; 45.50% at level 8. After the first stage, dysphagia was classified as 20% at level 4; 81% at level 5; 5% at level 8 demonstrating the maintenance of the dysphagia classification and the placebo effect of the proposed articulatory therapy. It must be considered that in this group 7.14% of the patients showed improvement in the PAS classification of dysphagia; suggesting that the guidelines given at the beginning of the study may have a beneficial effect; reinforcing the already known importance in patients. After performing the second videofluoroscopy in order to assess the maintenance of the therapy effect; the intervention group underwent a period with the placebo protocol and it can be observed that the majority (85.18%); there was maintenance of the presented dysphagia classification, suggesting that this effect is not only immediate. In the second intervention group; it was observed that 47.83% showed improvement in the dysphagia classification with 83.33% leaving level 8; more severe for levels 4 and 5; reinforcing the findings of the first wave. At the end of the study, only one of the patients remained with PAS 8; this being the only diabetic patient in the group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected secondary outcomes 1; Characterize the sociodemographic and clinical profile of the sample of patients undergoing OPHL Type IIa.;Secondary outcomes found 1; the population of the present study was predominantly composed of males 97.1%; elderly with an average of 68 years; stylists 70.6%; smokers 78%; with advanced staging; 55.8% corresponding to group III-IV and with low education 55.8%.;Expected secondary outcome 2; To characterize the swallowing profile of patients submitted to OPHL Type IIa; on the baseline.;Secondary outcomes found 2; after the analysis of the initial Videofluoroscopies; it was possible to conclude that all patients have dysphagia to some degree; being 28 patients with PAS 4; 29 patients with PAS 5 and 11 patients with PAS 8.;Expected secondary outcomes 3; to measure the improvement of swallowing safety in the group of patients after applying the protocol with the Shaker maneuver.;Secondary outcomes found 3; after applying the protocol; the Videofluoroscopy evaluation showed a significant improvement in the aspect of swallowing safety. Of the participants who started the first stage as an intervention group and had previously been classified as PAS level 8; all showed a reduction in the PAS classification to 5 and 4; as well as a 60% reduction was observed among patients in this same group; initially classified as 5 and later to 4.;Expected secondary outcomes 4; verify the short-term effect of the intervention after 6 weeks of completed exercise.;Secondary outcomes found 4; five participants started the second stage with the classification of level 8 in the PAS and after carrying out the intervention protocol, only 20% did not present an improvement in the dysphagia condition. Among the 14 patients classified as PAS 5; who performed the intervention protocol in the second stage; an improvement was observed in approximately 35% of patients who had dysphagia; for PAS 4. An increase of 16% from PAS 4 to 5 was also observed among the group | — |
Countries
Brazil
Contacts
Public ContactAndressa Freitas
Instituto Nacional do Câncer - INCA
Outcome results
None listed