Protection of Salivary Function by Concomitant Pilocarpine During Radiotherapy: A Double-Blind, Randomized, Placebo-Controlled Study

Journal Article · Tue Jan 01 04:00:00 EST 2008 · International Journal of Radiation Oncology, Biology and Physics

DOI:https://doi.org/10.1016/j.ijrobp.2007.06.016· OSTI ID:21039694

Roesink, Judith M ^[1]; Kampinga, Harm H ^[2]; Coppes, Rob P ^[3]; Terhaard, Chris ^[1]; Langendijk, Johannes A; Luijk, Peter van ^[3]; Stokman, Monique A; Vissink, Arjan ^[4]

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1. Department of Radiation Oncology, University Medical Center Utrecht, Utrecht (Netherlands)
2. Department of Cell Biology, Section for Radiation and Stress Cell Biology, University Medical Center Groningen, Groningen (Netherlands)
3. Department of Radiation Oncology, University Medical Center Groningen, Groningen (Netherlands)
4. Department of Oral and Maxillofacial Surgery, University Medical Center Groningen, Groningen (Netherlands)

Purpose: To investigate the effect of concomitant administration of pilocarpine during radiotherapy for head-and-neck squamous cell carcinoma (HNSCC) on postradiotherapy xerostomia. Methods and Materials: A prospective, double blind, placebo-controlled randomized trial including 170 patients with HNSCC was executed to study the protective effect of pilocarpine on radiotherapy-induced parotid gland dysfunction. The primary objective endpoint was parotid flow rate complication probability (PFCP) scored 6 weeks, 6 months, and 12 months after radiotherapy. Secondary endpoints included Late Effects of Normal Tissue/Somatic Objective Management Analytic scale (LENT SOMA) and patient-rated xerostomia scores. For all parotid glands, dose-volume histograms were assessed because the dose distribution in the parotid glands is considered the most important prognostic factor with regard to radiation-induced salivary dysfunction. Results: Although no significant differences in PFCP were found for the two treatments arms, a significant (p = 0.03) reduced loss of parotid flow 1 year after radiotherapy was observed in those patients who received pilocarpine and a mean parotid dose above 40 Gy. The LENT SOMA and patient-rated xerostomia scores showed similar trends toward less dryness-related complaints for the pilocarpine group. Conclusions: Concomitant administration of pilocarpine during radiotherapy did not improve the PFCP or LENT SOMA and patient-rated xerostomia scores. In a subgroup of patients with a mean dose above 40 Gy, pilocarpine administration resulted in sparing of parotid gland function. Therefore, pilocarpine could be provided to patients in whom sufficient sparing of the parotid is not achievable.

• OSTI ID: 21039694
• Journal Information: International Journal of Radiation Oncology, Biology and Physics, Journal Name: International Journal of Radiation Oncology, Biology and Physics Journal Issue: 1 Vol. 70; ISSN IOBPD3; ISSN 0360-3016
• Country of Publication: United States
• Language: English

Related Subjects

62 RADIOLOGY AND NUCLEAR MEDICINE
CARCINOMAS
FLOW RATE
GLANDS
HEAD
NECK
PATIENTS
PILOCARPINE
RADIATION DOSE DISTRIBUTIONS
RADIATION DOSES
RADIOTHERAPY
SAFETY