Swallowing Intervention During Radiochemotherapy on Head and Neck Cancer (Swallowing-1)
|ClinicalTrials.gov Identifier: NCT02075385|
Recruitment Status : Completed
First Posted : March 3, 2014
Last Update Posted : June 28, 2017
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
|Condition or disease||Intervention/treatment||Phase|
|Head Neck Cancer Swallowing Disorders||Procedure: pre, during and pos-treatment swallowing exercises||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Phase II Trial: Swallowing Speech Pathology Intervention During Radiochemotherapy on Patients With Head and Neck Cancer|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||August 2015|
Experimental: Speech pathology therapy
Pre, during and pos-treatment swallowing exercises.
Procedure: pre, during and pos-treatment swallowing exercises
Speech pathology therapy
Other Name: swallowing pathology therapy
No Intervention: Control group
These patients will not receive speech pathology therapy.
- Swallowing function [ Time Frame: up to 6 months after concurrent phase. ]Self-reporting swallowing questionnaire, clinical swallowing examination and modified barium swallow (MBS), and the MD Anderson Dysphagia Inventory (MDADI).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02075385
|Barretos Cancer Hospital|
|Barretos, São Paulo, Brazil, 14780400|
|Study Chair:||André L Carvalho, PHD||Fundação Pio XII - Hospital de Câncer de Barretos|
|Study Director:||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|
|Principal Investigator:||Juliana Portas, MSC||Fundação Pio XII - Hospital de Câncer de Barretos|