Swallowing Intervention During Radiochemotherapy on Head and Neck Cancer
Conditions
Head Neck Cancer - Swallowing Disorders
Conditions: official terms
Deglutition Disorders - Head and Neck Neoplasms
Conditions: Keywords
Dysphagia, speech language therapy, quality of life, induction chemotherapy, concurrent chemoradiotherapy
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: pre, during and pos-treatment swallowing exercises
Type: Procedure
Overall Status
Recruiting
Summary
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
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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
Location
Barretos Cancer Hospital
Barretos, São Paulo, Brazil
Status: Recruiting
Contact: Juliana Portas, MSc - +55 17 3321 6600 - julianaportas@globo.com
Start Date
July 2012
Completion Date
December 2014
Sponsors
Barretos Cancer Hospital
Source
Barretos Cancer Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page