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

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ClinicalTrials.gov Identifier: NCT02075385
Recruitment Status : Completed
First Posted : March 3, 2014
Last Update Posted : June 28, 2017
Sponsor:
Information provided by (Responsible Party):
Barretos Cancer Hospital

Brief 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


Condition or disease Intervention/treatment Phase
Head Neck Cancer Swallowing Disorders Procedure: pre, during and pos-treatment swallowing exercises Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial: Swallowing Speech Pathology Intervention During Radiochemotherapy on Patients With Head and Neck Cancer
Study Start Date : July 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : August 2015

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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 Name: swallowing pathology therapy

No Intervention: Control group
These patients will not receive speech pathology therapy.



Primary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02075385


Locations
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Brazil
Barretos Cancer Hospital
Barretos, São Paulo, Brazil, 14780400
Sponsors and Collaborators
Barretos Cancer Hospital
Investigators
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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

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Responsible Party: Barretos Cancer Hospital
ClinicalTrials.gov Identifier: NCT02075385     History of Changes
Other Study ID Numbers: 589/2012
First Posted: March 3, 2014    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: October 2015

Keywords provided by Barretos Cancer Hospital:
Dysphagia
speech language therapy
quality of life
induction chemotherapy
concurrent chemoradiotherapy

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Deglutition Disorders
Neoplasms by Site
Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases