The primary objective of this study is to evaluate the effectiveness of lipofilling in treatment of speech and swallowing impairment after treatment for head and neck cancer. The secondary objective is to evaluate the effect of lipofilling on tongue…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Functionele aandoeningen (slik en spraakproblemen)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Speech outcomes:
- Objective outcomes: Intelligibility, diadochokinesis, voice quality and vowel
space.
- Subjective outcomes: Speech Handicap Index
Swallowing outcomes:
- Objective outcomes: Penetration-aspiration scale, residue after swallowing,
Functional Oral Intake Scale en weight change.
- Subjective outcomes: EORTC QLQ-C30 en H&N35 en SWAL-QOL
Secondary outcome
Effect on tongue base volume, feasibility and patients' satisfaction.
Background summary
Treatment for head and neck cancer can lead to long-term functional impairments
such as dysphagia and speech problems. In this case, patients the patient
receives intensive therapy including behavioral swallowing rehabilitation from
the speech language pathologist. However, long-term functional impairment still
occurs in some patients refractory to these rehabilitation techniques.
Dysphagia is accompanied with comorbidity like aspiration pneumonia which, if
left untreated, might result death. When patients with chronic, severe
dysphagia often have no other options left, besides in some cases a functional
total laryngectomy in which the airway and upper digestive tract are separated,
lipofilling can be of potential value as *last resort* treatment. However,
results regarding short- and long-term effectiveness are lacking.
Study objective
The primary objective of this study is to evaluate the effectiveness of
lipofilling in treatment of speech and swallowing impairment after treatment
for head and neck cancer. The secondary objective is to evaluate the effect of
lipofilling on tongue (base) volume, feasibility and patient*s satisfaction.
Study design
Observational cohort study
Intervention
Lipofilling is a procedure wheren autologous fat is transplanted from the
abdominal wall/thigh to throat/oral cavity.
Study burden and risks
The experimental nature of the treatment will be discussed in detail with the
patient. The burden of this study consists of the possible complication of the
procedure (which are expected to be low after experience with previous treated
patients), as well as the time burden and minimal radiation risk of the
videofluoroscopy.
Plesmanlaan 121 Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121 Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
Patients with chronic, refractory speech and/or swallowing problems after treatment for head and neck cancer
According to the rehabilitative care team, there is no other option except lipofilling
Exclusion criteria
-
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 | NL61727.031.17 |