Swallowing Intervention During Radiochemotherapy on Head and Neck Cancer

Phase 2CompletedNCT02075385

Barretos Cancer Hospital94 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Head Neck Cancer Swallowing Disorders

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Swallowing function

Self-reporting swallowing questionnaire, clinical swallowing examination and modified barium swallow (MBS), and the MD Anderson Dysphagia Inventory (MDADI).

Time frame: up to 6 months after concurrent phase.