The effects of Phoniatric PREhabilitation in Head and Neck Cancer patients on Aspiration and Preservation of Swallowing

Phase 2

Conditions: Head and Neck Cancer (HNSCC)
R13.0

Registration Number: DRKS00029676

Lead Sponsor: niversitätsklinikum Regensburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 77

Inclusion Criteria

• Initial diagnosis of invasive head and neck squamous cell carcinoma

Exclusion Criteria

• T1 glottis carcinoma, salivary gland tumors, sinus, nasal and maxillofacial carcinomas, lip carcinomas, skin carcinomas
• Planned laryngectomy, total glossectomy, esophageal swallowing disorder
• No curative therapy
• Condition post therapy of carcinoma of the upper aerodigestive tract or esophageal carcinoma
• Post radiotherapy in the head and neck area
• Higher degree of cognitive impairment (e.g. dementia, Korsakow syndrome)
• Psychomotor impairment (e.g. Parkinson's), neurological pre-existing conditions with swallowing disorders (e.g. apoplexy)
• Age < 18 years
• ECOG > 2
• Patient is not able to fill out questionnaires even with help (insufficient ability to read and write, higher degree of insufficiently supplied hearing loss)
• Language barrier
• Pregnancy/lactation

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary study endpoints (complex endpoint family), 6 weeks after end of treatment:<br>• Swallowing function (objectively captured by FEES: PAS, Yale Residual Scale, subjectively by DHI and FOIS-G)<br>• emotional distress: anxiety and depression (HADS)

Secondary Outcome Measures

Name	Time	Method
Secondary study endpoints 6 weeks, 3 and 6 months, as well as 9 or 12 months after the end of oncological therapy: <br>- swallow-related quality of life (DHI; EORTC-QLQ-HN43; FOIS-G) <br>Time to decantulation <br>- Nutritional content by PEG in %<br>- Time of dependence on enteral nutritional substitution via PEG tube<br>- Incidence of complications (aspiration pneumonia) <br>- Inpatient length of stay, incl. readmission<br>- Nutritional status (BMI, albumin, bioelectrical impedance analysis) <br>- General quality of life (EORTC-QLQ-C30) <br>- Professional reintegration<br>- Subgroup analyses of elderly patients (>65 years) and patients with weaker social status<br>