Swallowing Intervention During Radiochemotherapy on Head and Neck Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2015-08-31

Brief Summary

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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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Detailed Description

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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).

Conditions

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Head Neck Cancer Swallowing Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Speech pathology therapy

Pre, during and pos-treatment swallowing exercises.

Group Type EXPERIMENTAL

pre, during and pos-treatment swallowing exercises

Intervention Type PROCEDURE

Speech pathology therapy

Control group

These patients will not receive speech pathology therapy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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pre, during and pos-treatment swallowing exercises

Speech pathology therapy

Intervention Type PROCEDURE

Other Intervention Names

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swallowing pathology therapy

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No