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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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Speech pathology therapy | Experimental | Pre, during and pos-treatment swallowing exercises. |
|
| Control group | No Intervention | These patients will not receive speech pathology therapy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pre, during and pos-treatment swallowing exercises | Procedure | Speech pathology therapy |
|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| André L Carvalho, PHD | Fundação Pio XII - Hospital de Câncer de Barretos | Study Chair |
| Luciano S Viana, PHD | Fundação Pio XII - Hospital de Câncer de Barretos | Study Director |
| Alexandre Jacinto, MD | Fundação Pio XII - Hospital de Câncer de Barretos | Study Director |
| Juliana Portas, MSC | Fundação Pio XII - Hospital de Câncer de Barretos | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barretos Cancer Hospital | Barretos | São Paulo | 14780400 | Brazil |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D003680 | Deglutition Disorders |
| D003147 | Communication Disorders |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D007854 | Lead |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
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| D004066 |
| Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |