To investigate whether stem cell sparing radiotherapy results in a lower risk of dry-mouth syndrome than current standard treatment technique.
ID
Source
Brief title
Condition
- Other condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Health condition
Radiotherapie complicaties: Xerostomie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Incidence of parotid gland dysfunction (reduction of saliva production to less
than 25% of the production pre-radiotherapy.)
Secondary outcome
Physician-rated xerostomia (CTCAE v4.0)
GRIX questionnaire (Groningen Radiation Induced Xerostomia questionnaire)
Patient-rated xerostomia (questionnare EORTC QLQ-H&N35)
Background summary
Approximately 40% of patients treated with radiotherapy for head-and-neck
cancer develop dry-mouth syndrome. This complicates eating and increases the
risk of dental loss.This side-effect is often permanent and percieved as very
inconvenient by most patients. An important reason for developing dry-mouth
syndrome is that the largest salivary gland (parotis) is (partially)
co-irradiated. Depending on the radiation dose this causes damage to these
glands.
Radiation is targetted to the tumor and lymphnodes, while trying to minimize
the mean dose to both parotid glands. However, still 40% of the patients
develops dry-mouth syndrome. During treatment this can even be 80%. However in
roughly half the patients this recovers due to functional recovery of the
parotid gland. Whether this happens depends on the availability after
radiotherapy of stem cells in the parotid gland, capable of regerating parotid
gland tissue.
Recently it was discovered at the UMCG that these stem cells reside in the
major ducts of the gland. However, at present mean dose to the entire parotid
gland is minimized without specifically taking into account the location of its
stem cells.
A sensible next step is to try and reduce the radiation dose specifically in
the part of the parotid gland that contains its stem cells. This increases the
likelihood that stem cells survive the radiotherapy treatment and thereby
reduces the risk of dry mouth syndrome.
Study objective
To investigate whether stem cell sparing radiotherapy results in a lower risk
of dry-mouth syndrome than current standard treatment technique.
Study design
Randomised dubble-blind placebo-controled.
Intervention
A reduction of the radiation dose specifically in the part of the parotid gland
where most of its stem cells reside.
Study burden and risks
Both the standard and experimental arms meet the constraints to which current
treatment of head and neck cancer is subjected. As such the experimental arm
does not yield any additional risk as compared to the standard arm. Moreover,
since the intervention only involves a change in treatment technique, this does
not yield any additional burden to the patient.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
Patients treated with planned curative primary radiotherapy for HNC, with or without chemotherapy or cetuximab meeting the following criteria:
- Squamous cell carcinoma originating from the mucosa of the head and neck area or nasofaryngeal carcinoma originating from the nasofarynx;
- The radiotherapy includes prophylactic or therapeutic irradiation of both sides of the neck (at least level II to IV);
- Age * 18 years;
- WHO performance 0-2;
- pre-treatment stimulated parotid gland saliva production >0.2 ml/min.
Exclusion criteria
- Postoperative radiotherapy;
- Re-irradiation;
- Unilateral radiotherapy;
- Primary salivary gland tumours
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 | NL40547.042.12 |