Swallowing Intervention During Radiochemotherapy on Head and Neck Cancer

Head Neck Cancer Clinical Trial

— Swallowing-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02075385
• Other study ID #: 589/2012
• Status: Completed
• Phase: Phase 2
• First received: January 23, 2014
• Last updated: June 27, 2017
• Start date: July 2012
• Est. completion date: August 2015

Study information

• Verified date: October 2015
• Source: Barretos Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: August 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Head and Neck Neoplasms
• Head Neck Cancer
• Swallowing Disorders

Intervention

Procedure:
• pre, during and pos-treatment swallowing exercises
Speech pathology therapy

Locations

Country	Name	City	State
Brazil	Barretos Cancer Hospital	Barretos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Barretos Cancer Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Swallowing function	Self-reporting swallowing questionnaire, clinical swallowing examination and modified barium swallow (MBS), and the MD Anderson Dysphagia Inventory (MDADI).	up to 6 months after concurrent phase.