Effectiveness of cevimeline to improve oral health in patients with postradiation xerostomia.
BACKGROUND
We assessed the effectiveness of cevimeline 30 mg 3 times daily in patient-reported oral health (Oral Health Impact Profile [OHIP-49]) and quality of life (QOL) in patients with xerostomia.


METHODS
In our investigator-initiated, multicenter, randomized, double-blind, placebo-controlled study, patients who received >40 Gy of radiation therapy to the head and neck including at least 3 major salivary glands were randomized to cevimeline 30 mg or placebo orally 3 times daily for 6 weeks. Patients had to have grade 1 or 2 xerostomia and be >16 weeks posttreatment. Clinical data were collected and questionnaires administered at baseline and week 6. The primary outcome was change in OHIP-49 total score from baseline to week 6.


RESULTS
No statistically significant differences in oral health or QOL were observed. During the 6 weeks of the study, the severity of xerostomia decreased from baseline.


CONCLUSIONS
Xerostomia is a significant sequela of treatment of head and neck cancer that may improve with time. The role of oral parasympathetic muscarinic secretogogues in alleviating patient symptoms and complaints remains unclear.
Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA. david.witsell@duke.edu
David L
DL
Witsell
Sandra
S
Stinnett
Mark S
MS
Chambers
D002294:Carcinoma, Squamous Cell / Q000532:radiotherapy; D004311:Double-Blind Method; D005260:Female; D006258:Head and Neck Neoplasms / Q000532:radiotherapy; D006801:Humans; D008297:Male; D018721:Muscarinic Agonists / Q000627:therapeutic use*; D009909:Oral Health; D011788:Quality of Life; D011812:Quinuclidines / Q000627:therapeutic use*; D011878:Radiotherapy / Q000009:adverse effects*; D012469:Salivary Glands / Q000528:radiation effects; D012720:Severity of Illness Index; D013876:Thiophenes / Q000627:therapeutic use*; D014987:Xerostomia / Q000188:drug therapy* / Q000209:etiology
D018721:Muscarinic Agonists; D011812:Quinuclidines; D013876:Thiophenes; C059240:cevimeline