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

Primary Purpose

Head Neck Cancer, Swallowing Disorders

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
pre, during and pos-treatment swallowing exercises
Sponsored by
Barretos Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head Neck Cancer focused on measuring Dysphagia, speech language therapy, quality of life, induction chemotherapy, concurrent chemoradiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Barretos Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Speech pathology therapy

Control group

Arm Description

Pre, during and pos-treatment swallowing exercises.

These patients will not receive speech pathology therapy.

Outcomes

Primary Outcome Measures

Swallowing function
Self-reporting swallowing questionnaire, clinical swallowing examination and modified barium swallow (MBS), and the MD Anderson Dysphagia Inventory (MDADI).

Secondary Outcome Measures

Full Information

First Posted
January 23, 2014
Last Updated
June 27, 2017
Sponsor
Barretos Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02075385
Brief Title
Swallowing Intervention During Radiochemotherapy on Head and Neck Cancer
Acronym
Swallowing-1
Official Title
Randomized Phase II Trial: Swallowing Speech Pathology Intervention During Radiochemotherapy on Patients With Head and Neck Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barretos Cancer Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Neck Cancer, Swallowing Disorders
Keywords
Dysphagia, speech language therapy, quality of life, induction chemotherapy, concurrent chemoradiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Speech pathology therapy
Arm Type
Experimental
Arm Description
Pre, during and pos-treatment swallowing exercises.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
These patients will not receive speech pathology therapy.
Intervention Type
Procedure
Intervention Name(s)
pre, during and pos-treatment swallowing exercises
Other Intervention Name(s)
swallowing pathology therapy
Intervention Description
Speech pathology therapy
Primary Outcome Measure Information:
Title
Swallowing function
Description
Self-reporting swallowing questionnaire, clinical swallowing examination and modified barium swallow (MBS), and the MD Anderson Dysphagia Inventory (MDADI).
Time Frame
up to 6 months after concurrent phase.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
André L Carvalho, PHD
Organizational Affiliation
Fundação Pio XII - Hospital de Câncer de Barretos
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Luciano S Viana, PHD
Organizational Affiliation
Fundação Pio XII - Hospital de Câncer de Barretos
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alexandre Jacinto, MD
Organizational Affiliation
Fundação Pio XII - Hospital de Câncer de Barretos
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Juliana Portas, MSC
Organizational Affiliation
Fundação Pio XII - Hospital de Câncer de Barretos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barretos Cancer Hospital
City
Barretos
State/Province
São Paulo
ZIP/Postal Code
14780400
Country
Brazil

12. IPD Sharing Statement

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Swallowing Intervention During Radiochemotherapy on Head and Neck Cancer

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