To assess swallowing and speech function in patients ten years after CRT for head and neck cancer with preventive rehabilitation in order to compare these results with those after six years and to those of patients after CRT without preventive…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Functionele beperkingen op het gebied van slikken en spreken.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Objective swallowing outcomes
o Videofluoroscopy
o Other parameters: tube dependency/nutritional supplements, Functional Oral
Intake Scale (FOIS), weight change/BMI, maximal inter-incisal opening (MIO),
symptom specific questions, pain (VAS)
- Objective speech outcomes
o Speech recordings
- Subjective outcomes
o SWAL-QOL
o Voice Handicap Index
o Speech Handicap Index
o EORTC QLQ-C30 and H&N35
o EQ-5D-5L
o Study specific questions
Secondary outcome
Not applicable
Background summary
Despite good results on survival, chemoradiotherapy (CRT) for head and neck
cancer is associated with substantial short- and long-term toxicities. In order
to prevent these toxicities from occurring, multiple studies have investigated
preventive rehabilitation strategies. Results on these strategies show
effectiveness on functional outcomes. However, since functional outcomes can
deteriorate years after CRT, long-term results are essential to provide
information regarding the effectiveness of preventive exercises in head and
neck cancer survivors.
Study objective
To assess swallowing and speech function in patients ten years after CRT for
head and neck cancer with preventive rehabilitation in order to compare these
results with those after six years and to those of patients after CRT without
preventive rehabilitation.
Study design
Prospective observational cohort study
Study burden and risks
The primary burden for the individual patient is the time it takes to complete
the assessments (70 minutes). The main risk involves the added (relatively low)
radiation exposure during the videofluoroscopy.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
Inclusion criteria
Evaluable and disease-free head and neck cancer survivors who participated in the randomized controlled trial regarding a preventive rehabilitation program during chemoradiotherapy, performed ten years ago.
Exclusion criteria
(suspected) recurrent head and neck cancer
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL63465.031.17 |