Swallowing Intervention During Radiochemotherapy on Head and Neck Cancer

Study Overview
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Brief Summary
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General Objective: To evaluate the swallowing results of speech pathologist rehabilitation of advanced oropharynges, larynx and hypopharynx cancer patients during neoadjuvant chemotherapy and radiotherapy concomitant to chemotherapy. Methods and Casuistic: Randomized clinical trial phase II. 80 patients with advanced oropharynges, larynx and hypopharynx cancer diagnoses from Barretos Cancer Hospital, which had the proposal of neoadjuvant chemotherapy followed by radiotherapy combined with chemotherapy. Patients are randomized on two groups: control group and speech pathology therapy group

Detailed Description
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To evaluate and compare the swallowing and life quality swallowing on a group undergoing to speech pathology therapy (intervention) and a control group (no intervention).

Official Title
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Randomized Phase II Trial: Swallowing Speech Pathology Intervention During Radiochemotherapy on Patients With Head and Neck Cancer

Conditions
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Head Neck Cancer, Swallowing Disorders

Intervention / Treatment
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* Procedure: pre, during and pos-treatment swallowing exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Head and neck squamous cell carcinoma Indication for the protocol treatment of neoadjuvant chemotherapy followed by radiotherapy concomitant to chemotherapy. Oropharynges, larynx and hypopharynx advanced cancer (T3 or T4), classified as resectable; 18 years old or older; informed consent signed before any specific procedure Exclusion Criteria: Previous head and neck surgery Previous radiotherapy or chemotherapy Previous history of neoplasia, excepted for in situ carcinoma of endometrial (uterine) cancer, skin basal cell or squamous cell carcinoma; Severe laryngeal aspiration during all consistencies swallowing evaluated thought videofluoroscopy Patients with cognitive deficit which could not comprehend the speech pathology intervention.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Speech pathology therapy<br>Pre, during and pos-treatment swallowing exercises. | Procedure: pre, during and pos-treatment swallowing exercises<br>* Speech pathology therapy<br>* Other names: swallowing pathology therapy;|
| No Intervention: Control group<br>These patients will not receive speech pathology therapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Swallowing function | Self-reporting swallowing questionnaire, clinical swallowing examination and modified barium swallow (MBS), and the MD Anderson Dysphagia Inventory (MDADI). | up to 6 months after concurrent phase. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dysphagia, speech language therapy, quality of life, induction chemotherapy, concurrent chemoradiotherapy