Preventive Swallowing Exercises to prevent persistent swallowing dysfunction after curative (chemo)-radiation in head and neck cancer

Preventive Swallowing Exercises to prevent persistent swallowing dysfunction after curative (chemo)-radiation in head and neck cancer - PSE / head and neck matters

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36292

Enrollment

Registered

2011-04-18

Start date

2011-07-17

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

head and neck cancer shoulderproblems speech swallowing

Interventions

The PSE guided exercise protocol ("Halszaken"

Head and Neck matters) consists of flexibility exercises for head, neck and shoulders and voice, speech and swallowing exercises, including range of motion and resistance exercises. The protocol ta

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Head and neck squamous cell cancer, with the primary site origination in the oral cavity, oropharynx, hypopharynx, nasopharynx and larynx or patients with lymph node metastases from an unknown primary tumor Stage I - IV (UICC staging system 2002) planned for curative RT with or without chemotherapy / cetuximab

Exclusion criteria

Exclusion criteria: serious cognitive impairment lack of basic fluency in the Dutch language

Design outcomes

Primary

Measure	Time frame
RTOG/EORTC late radiation morbidity scoring schema for dysphagia	—

Secondary

Measure	Time frame
RTOG acute dysphagia tube feeding dependency at 6 months after competion of (chemo-)radiation quality of life questionnaires: - EORTC QLQ-H&N35 - SWALQOL - SHI - SDQ - EORTC QLQ-C30 - EuroQol-5D - HADS	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)