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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02075385
Other study ID # 589/2012
Secondary ID
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
Health authority
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.

Study Design


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.
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