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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

DRKS

Registry ID

DRKS00029676

Enrollment

Registered

2022-07-19

Start date

2022-07-19

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Head and Neck Cancer (HNSCC) R13.0

Interventions

Group 1: Intervention group: Complex phoniatric intervention, individual and preventive counseling, speech therapy exercise program, malnutrition management Group 2: Control group: guideline-compliant

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Initial diagnosis of invasive head and neck squamous cell carcinoma

Exclusion criteria

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 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

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactGerda Pfleger

Klinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde, Studienzentrum, Universitätsklinikum Regensburg

gerda.pfleger@ukr.de094194419493

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 8, 2026