Swallowing Intervention During Radiochemotherapy on Head and Neck Cancer

NCT02075385 | Completed Phase 2 DMC

• 1 other identifier: 589/2012
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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

Conditions

Head Neck Cancer; Swallowing Disorders

Keywords

Dysphagia; speech language therapy; quality of life; induction chemotherapy; concurrent chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Speech pathology therapy

EXPERIMENTAL

Pre, during and pos-treatment swallowing exercises.

Procedure: pre, during and pos-treatment swallowing exercises

Control group

NO INTERVENTION

These patients will not receive speech pathology therapy.

Interventions

pre, during and pos-treatment swallowing exercises PROCEDURE

Speech pathology therapy

Also known as: swallowing pathology therapy

Speech pathology therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• years old or older;
• informed consent signed before any specific procedure

You may not qualify if:

• 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.

Sponsors & Collaborators

• Barretos Cancer Hospital: lead

Study Sites (1)

Barretos Cancer Hospital

Barretos, São Paulo, 14780400, Brazil

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Deglutition Disorders; Communication Disorders

Interventions

Lead

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Metals

Study Officials

• André L Carvalho, PHD

  Fundação Pio XII - Hospital de Câncer de Barretos

  STUDY CHAIR

• 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

  STUDY DIRECTOR

• Juliana Portas, MSC

  Fundação Pio XII - Hospital de Câncer de Barretos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2014
• First Posted: March 3, 2014
• Study Start: July 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: August 1, 2015
• Last Updated: June 28, 2017

Record last verified: 2015-10

Locations

BR (1)