Swallowing Intervention During Radiochemotherapy on Head and Neck Cancer

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

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Key information

Conditions

Head Neck Cancer Communication Disorders Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Head and Neck Neoplasms Mental Disorders Neoplasms Neoplasms by Site Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Signs and Symptoms Swallowing Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Barretos Cancer Hospital

Barretos, São Paulo, 14780400, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pre, during and pos-treatment swallowing exercises

Procedure

Speech pathology therapy

Other names: swallowing pathology therapy

Primary outcomes

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).

Sponsors and collaborators

Lead sponsor

Barretos Cancer Hospital

Other

Registry information

Official study title

Randomized Phase II Trial: Swallowing Speech Pathology Intervention During Radiochemotherapy on Patients With Head and Neck Cancer

Acronym: Swallowing-1

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2015
First posted: Mar 3, 2014
Registry last updated: Jun 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed