Impact of speech therapy on dysphagia and trismus in head-and-neck cancer patients

Phase 2

Conditions: C10
C13
Malignant neoplasm of oropharynx
Malignant neoplasm of hypopharynx

Registration Number: DRKS00021287

Lead Sponsor: niversitätsklinikum Freiburg, Klinik für Strahlenheilkunde

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 66

Inclusion Criteria

• Patients with a histologically proven, locally advanced (=T3 and/or N+) carcinoma of the oro- or hypopharynx without distant metastases; • Indication for a definitive or adjuvant (chemo)radiotherapy with an intended radiation dose between 50 Gy and 70 Gy; • Age = 18 years; • Karnofsky performance status = 70%; • Patient education and written consent for participation in the study

Exclusion Criteria

• Considerable neurological or psychiatric diseases including dementia and epilepsy; • Medical condition that impairs successful completion of the study or impedes adequate patient education; • Previous tumor treatment (surgery or irradiation) in the head-and-neck region > 3 months ago; • Impairment of the swallowing function prior to radiotherapy treatment, e.g. after other operative interventions in the head-and-neck region; • Lack of legal capacity

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bogenhausener Dysphagia Score (BODS) at 3 months after radiotherapy.

Secondary Outcome Measures

Name	Time	Method
BODS at 6 and 24 months after radiotherapy; Quality of life quantified by EQ-5D-5L, DHI and EORTC H&N 35 questionnaires; Body weight; Maximum mouth opening; Prevalence of percutaneous endoscopic gastrostomy (PEG).