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. 2016 Aug 26;2016(8):CD011112. doi: 10.1002/14651858.CD011112.pub2

Barretos Cancer Hospital 2015.

Trial name or title Swallowing intervention during radiochemotherapy on head and neck cancer (Swallowing‐1)
Methods Randomised clinical trial phase II; single‐centre
Participants Age for study: < 18 years
Gender: both
n = 80 patients with advanced oropharynx, larynx and hypopharynx cancer diagnoses from Barretos Cancer Hospital, proposed for neoadjuvant chemotherapy followed by radiotherapy combined with chemotherapy
Inclusion criteria:

  • Head and neck squamous cell carcinoma

  • Indication for the protocol treatment of neoadjuvant chemotherapy followed by radiotherapy concomitant to chemotherapy

  • Oropharynx, 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 who could not comprehend the speech pathology intervention
Interventions 2 groups: control group (no intervention) and speech pathology therapy (swallowing exercise) group
Procedure: pre‐, during and post‐treatment swallowing exercises given by speech pathologist(s)
Outcomes Primary: swallowing function (time frame: up to 6 months after concurrent phase). Designated as safety issue: No 1
Measures: self‐reporting swallowing questionnaire, clinical swallowing examination; VFSS or modified barium swallow (MBS), and the MD Anderson Dysphagia Inventory (MDADI)
Starting date July 2012
 Completed: November 2014 (final data collection date for primary outcome measure)
Contact information Barretos Cancer Hospital, Barretos, São Paulo, Brazil, 14780400
Notes To evaluate and compare the swallowing and quality of life of a patient group undergoing a speech pathology therapy (intervention) and a control group (no intervention)