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Prevention of radiation-induced parotid gland dysfunction by parotid-gland stem-cell sparing intensity-modulated radiotherapy (SCS-IMRT)

Prevention of radiation-induced parotid gland dysfunction by parotid-gland stem-cell sparing intensity-modulated radiotherapy (SCS-IMRT) - Parotid gland stem cell sparing radiotherapy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON36912
Enrollment
102
Registered
2012-12-05
Start date
2013-09-17
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiotherapie complicaties: Xerostomie dry-mouth syndrome xerostomia

Interventions

A reduction of the radiation dose specifically in the part of the parotid gland where most of its stem cells reside.

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - Postoperative radiotherapy; - Re-irradiation; - Unilateral radiotherapy; - Primary salivary gland tumours

Design outcomes

Primary

MeasureTime frame
Incidence of parotid gland dysfunction (reduction of saliva production to less than 25% of the production pre-radiotherapy.)

Secondary

MeasureTime frame
Physician-rated xerostomia (CTCAE v4.0) GRIX questionnaire (Groningen Radiation Induced Xerostomia questionnaire) Patient-rated xerostomia (questionnare EORTC QLQ-H&N35)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)