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

June 27, 2017 updated by: Barretos Cancer Hospital

Randomized Phase II Trial: Swallowing Speech Pathology Intervention During Radiochemotherapy on Patients With 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

94

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Barretos, São Paulo, Brazil, 14780400
        • Barretos Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Speech pathology therapy
Pre, during and pos-treatment swallowing exercises.
Procedure: pre, during and pos-treatment swallowing exercises
Speech pathology therapy
Other Names:
  • swallowing pathology therapy
No Intervention: Control group
These patients will not receive speech pathology therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
up to 6 months after concurrent phase.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barretos Cancer Hospital

Investigators

  • Study Chair: André L Carvalho, PHD, Fundação Pio XII - Hospital de Câncer de Barretos
  • Study Director: Luciano S Viana, PHD, Fundação Pio XII - Hospital de Câncer de Barretos
  • Study Director: Alexandre Jacinto, MD, Fundação Pio XII - Hospital de Câncer de Barretos
  • Principal Investigator: Juliana Portas, MSC, Fundação Pio XII - Hospital de Câncer de Barretos

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

January 23, 2014

First Submitted That Met QC Criteria

February 28, 2014

First Posted (Estimate)

March 3, 2014

Study Record Updates

Last Update Posted (Actual)

June 28, 2017

Last Update Submitted That Met QC Criteria

June 27, 2017

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 589/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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