The primary objective of this study is to investigate how treatment affects tissue elasticity and to what extent those effects vary in patients. The secondary objective is to link elasticity to tongue muscle strength and to functional outcome.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Group 1 (Partial glossectomy patients)
* Elasticity of operated side/scar tissue
* Elasticity of tongue tissue contralateral to operational side (healthy tissue)
Group 2 ((chemo)radiation patients)
* Elasticity of tongue tissue that received the highest dose [Gray]
* Elasticity of tongue tissue that received the lowest dose [Gray]
Group 3 (healthy volunteers)
* Elasticity of left side tongue tissue
* Elasticity of right side tongue tissue
Secondary outcome
Group 1 (Partial glossectomy patients)
* Tongue muscle strength operated side/ scar tissue
* Tongue muscle strength of tongue tissue contralateral to operational side
(healthy tissue)
Group 2 ((chemo)radiation patients)
* Tongue muscle strength of tongue tissue area that received the highest dose
[Gray]
* Tongue muscle strength of tongue tissue area that received the lowest dose
[Gray]
Group 3 (healthy volunteers)
* Tongue muscle strength of left side tongue tissue
* Tongue muscle strength of right side tongue tissue
Background summary
Among all treatments of cancer, surgery of locally advanced head and neck
cancer has one of the highest risks of loss of vital functions. Speech,
mastication and swallowing are complex functions that are easily affected. The
term *functional inoperability* is used when unacceptable function loss after
surgery is to be expected. Organ-sparing chemoradiation for advanced oral
cancer is used as an alternative to surgery. The choice between these two
treatment modalities is not evidence based. Elastic properties of the tongue
are strongly influenced by postoperative and post radiation fibrotic changes.
Therefore fibrosis and other effects on tissue elasticity should be studied
closely. Shear wave ultrasound elastography is a method to measure tissue
elasticity.
Study objective
The primary objective of this study is to investigate how treatment affects
tissue elasticity and to what extent those effects vary in patients. The
secondary objective is to link elasticity to tongue muscle strength and to
functional outcome.
Study design
Prospective feasibility study
Study burden and risks
The extent of burden:
* Control visit at the radiology deparment for an ultrasound will be extended
with 10 minutes.
This procedure is not considered to be of any physical harm to the patient.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
Inclusion criteria
Primary tongue cancer (T1-T4).
Primary surgery treatment or primary treatment with radiation therapy.
Patient should already have an appointment at the radiology department
Older than 18 years
Informed consent
Exclusion criteria
Patients:
Treatment for recurrent or residual tongue cancer
Location of tumour was on the tip of the tongue (not visible on US);Healthy volunteers:
History of oral cancer
History of other oral cavity diseases.
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 | NL60754.031.17 |