Swallowing Intervention During Radiochemotherapy on Head and Neck Cancer

Randomized Phase II Trial: Swallowing Speech Pathology Intervention During Radiochemotherapy on Patients With Head and Neck Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02075385

Acronym

Swallowing-1

Enrollment

Registered

2014-03-03

Start date

2012-07-31

Completion date

2015-08-31

Last updated

2017-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head Neck Cancer, Swallowing Disorders

Keywords

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

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).

Interventions

PROCEDUREpre, during and pos-treatment swallowing exercises

Speech pathology therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Swallowing function	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).

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026