Swallowing Intervention During Radiochemotherapy on Head and Neck Cancer (Swallowing-1)

Barretos Cancer Hospital

Status and phase: Completed; Phase 2

Conditions: Head Neck Cancer; Swallowing Disorders

Treatments: Procedure: pre, during and pos-treatment swallowing exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT02075385

589/2012

Details and patient eligibility

About

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

Full 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).

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Speech pathology therapy

Experimental group

Description:

Pre, during and pos-treatment swallowing exercises.

Treatment:

Procedure: pre, during and pos-treatment swallowing exercises

Control group

No Intervention group

Description:

These patients will not receive speech pathology therapy.