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Effect of Electrostimulation on swallowing biomechanics after Radiotherapy

Effect of Electrostimulation on swallowing biomechanics after Radiotherapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9y9p68g
Enrollment
Unknown
Registered
2023-05-08
Start date
2022-01-02
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oropharyngeal Neoplasms

Interventions

The sample size required to meet these criteria is 56 volunteers per group, for a total of 112 volunteers. The macaron will open. Adult individuals over 18 years old will be included
with a diagnosis of head and neck cancer, who have undergone radiotherapy, and have completed it, in the head and neck region, with or without chemotherapy and/or associated surgery, and present skin
E02.331.800

Sponsors

Irmandade Santa Casa de Misericórdia de Porto Alegre
Lead Sponsor
Irmandade Santa Casa de Misericórdia de Porto Alegre
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult individuals over 18 years of age; diagnosed with head and neck cancer; submitted to radiotherapy in the head and neck region, with or without associated chemotherapy and/or surgery; having finished the radiotherapy and presenting skin integrity and medical clearance to use the technique

Exclusion criteria

Exclusion criteria: Patients with contraindications for electrical stimulation: skin alterations in the region where the electrotherapy will be applied, use of a pacemaker or any other devices or alterations that make electrical stimulation impossible; with an active tumor in the region that will receive electrical current

Design outcomes

Primary

MeasureTime frame
It is expected that assessing the level of pharyngeal residue will be the primary endpoint, determined by the Eisenhuber scale and residue scale, which will indicate the effect of the electric current on dysphagia rehabilitation.

Secondary

MeasureTime frame
It is expected to evaluate the level of alteration of the objective parameters evaluated in the swallowing videofluoroscopy exam, such as oral preparation, organization and force of ejection, posterior escape into the valleculae, escape into the piriform recesses, hyolaryngeal elevation and anteriorization, food stasis in valleculae, whitening, laryngeal penetration and laryngotracheal aspiration. The method used to verify the expected outcome will be the performance of a new swallowing videofluoroscopy exam after the interventions.;Check evolution by means of the oral intake scale - FOIS.;Assess quality of life using the M. D. Anderson dysphagia questionnaire (MDADI)

Countries

Brazil

Contacts

Public ContactFernanda Korspalski

Irmandade Santa Casa de Misericórdia de Porto Alegre

tormenfernanda49@gmail.com+555199601488

Outcome results

None listed

Source: REBEC (via WHO ICTRP)