The objective of this study is to determine the prevalence of xerostomia after radiotherapy of oropharyngeal tumors when sparing the parotid glands and one submandibular gland.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The number of patients with patient-reported xerostomia one year after
radiotherapy determined using questionnaires (EORTC QLQ-H&N 35).
Secondary outcome
Objectively determined submandibulair flow complication. A complication is
defined as a submandibular flow less than 25% of the pre-radiotherapy values.
General quality of life after submandibular gland sparing radiotherapy.
Radiation-induced damage to the salivary system detected by MRI.
Background summary
Xerostomia after radiotherapy of the head-and-neck is a severe complication
caused by radiation damage to the salivary system. In a previous study we have
determined the prevalence of xerostomia after parotid gland sparing
radiotherapy. Although the function of the parotid glands was partly
preserved, still a large number of patients complained of moderate to severe
xerostomia. This probably due to radiation damage to the submandibular gland
which produces saliva during rest. In this study we now spare, besides the
parotid glands, also one submandibular gland. The prevalence of xerostomia in
this group will be compared with that in the previous group.
Study objective
The objective of this study is to determine the prevalence of xerostomia after
radiotherapy of oropharyngeal tumors when sparing the parotid glands and one
submandibular gland.
Study design
Patients will be treated with radiotherapy for cancer in the oropharynx. De
radiation damage to the salivary system after radiotherapy, that aims to spare
the parotid glands and one submandibular gland, will be assessed using
questionnaires, flow measurements and MR imaging.
The prevalence of xerostomia in this group will be compared with that in a
historical control group in which only the parotid glands were spared and that
received the same questionnaires and flow measurements.
Study burden and risks
The burden associated with participation consists of salivary flow
measurements, questionnaires and MRI measurements is relatively low. No risks
are associated with these additional measurements and we try to avoid that
patients have an extra visit to the hospital.
Heidelberglaan 100
3584 CX Utrecht
NL
Heidelberglaan 100
3584 CX Utrecht
NL
Listed location countries
Age
Inclusion criteria
Patients treated with radiotherapy for squamous cell carcinoma of the oropharynx.
Exclusion criteria
Previous radiotherapy of the salivary glands
Previous surgery of the salivary glands
Malignancies or other diseases of the salivary glands
TNM stages N2c and N3
Distant metastatic disease
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 | NL23117.041.08 |