Swallowing Intervention During Radiochemotherapy on Head and Neck Cancer

Phase 2

Completed

• Conditions: Head Neck Cancer; Swallowing Disorders
• Interventions: Procedure: pre, during and pos-treatment swallowing exercises

• Registration Number: NCT02075385
• Lead Sponsor: Barretos Cancer Hospital

Brief 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).

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2014-01-23
• Study First Submitted QC: 2014-02-28
• Study First Posted: 2014-03-03
• Primary Completion: 2014-11
• Study Completion: 2015-08
• Status Verified: 2015-10
• Last Update Submitted: 2017-06-27
• Last Update Posted: 2017-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Speech pathology therapy	pre, during and pos-treatment swallowing exercises	Pre, during and pos-treatment swallowing exercises.

Primary Outcome Measures

Name	Time	Method
Swallowing function	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).

Trial Locations

Locations (1)

Barretos Cancer Hospital; 🇧🇷 Barretos, São Paulo, Brazil