Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontology
Oral medicineDouble-blind randomized, placebo-controlled study of pilocarpine to salvage salivary gland function during radiotherapy of patients with head and neck cancer☆
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Study design and study population
The Research-Ethics Committee of the Jewish General Hospital approved this randomized clinical trial (RCT). Adult subjects who received external beam radiotherapy, using a bilateral radiation technique encompassing ≥2/3 of all major and minor salivary glands for a minimum of 5000 cGy (200 cGy per day) for 5 to 7 weeks, to the HN area were selected from March 1998 to September 2001. Patients were not excluded if they would receive concomitant chemotherapy. Radiation doses, stage of cancer, and
First study phase
Of a total of 80 patients invited to participate, 4 were excluded before randomization. Of 76 eligible patients, 62 (82%) accepted to participate. Of the 14 patients that refused, 9 were men with a mean age of 61 years (95%CI 55.1-67.5). Four patients were not randomized, for unknown reasons.
Fifty-eight patients consisting of 50 males and 8 females with a mean age 59.8 years (SD 11.81) were randomized to pilocarpine and placebo groups. Age, gender, radiation dose, chemotherapy, tumor site,
Discussion
In our study, salivary flow decreased in all patients, with no significant difference between pilocarpine and placebo groups. No difference in the level of severity of xerostomia was also noted in another RCT, including 130 patients with head and neck cancer.21 It has been observed, however, that salivary flow significantly decreased after radiotherapy in both pilocarpine and placebo groups21., 22.. However, the pilocarpine group, had a smaller reduction in flow and a lower frequency of oral
Conclusions
Pilocarpine reduced discomfort and pain symptoms as well; an improved global quality of life was reported only at the conclusion of the first study phase. The use of pilocarpine during radiotherapy (RT) did not significantly affect xerostomia or saliva production. The conclusions after the second study phase may be difficult to establish owing to the large number of noncompliant patients and the small sample size. However, our results demonstrate that pilocarpine given during RT did not improve
References (28)
- et al.
Salivary flow rates in patients with head and neck cancer 0.5 to 25 years after radiotherapy
Oral Surg Oral Med Oral Pathol Oral Radiol Endod
(1990) - et al.
Parotid gland function during and following radiotherapy of malignancies in the H&N
Eur J Cancer
(1992) - et al.
Evaluation of the dose for postoperative radiotherapy of head and neck cancer: first report of a prospective randomized trial
Int J Radiat Oncol Biol Phys
(1993) - et al.
Concomitant pilocarpine during head and neck irradiation is associated with decreased post treatment xerostomia
Int J Radiat Oncol Biol Phys
(1997) - et al.
Phase III placebo-controlled trial of oral pilocarpine in patients undergoing radiotherapy for head-and-neck cancer
Int J Radiat Oncol Biol Phys
(2002) - et al.
Radiation-induced hyposalivation and its treatment with oral pilocarpine
Oral Surg Oral Med Oral Pathol Oral Radiol Endod
(1998) - et al.
Radiation-induced xerostomia in cancer patients
Cancer
(1976) - et al.
Pilocarpine treatment of salivary gland hypofunction and dry mouth (xerostomia)
Arch Intern Med
(1991) - et al.
Xerostomia—clinical evaluation and treatment in general practice
J Calif Dent Assoc
(2000) - et al.
Effect of fractionated radiation on salivary gland function
Cancer
(1972)
Effect of radiotherapy on whole saliva flow
J Dent Res
Clinical aspects of Xerostomia
J Clin Psychiatry
Effectiveness of pilocarpine in post-radiation xerostomia
Cancer
The effect of pharmacologic agents on salivary secretion and composition in man.I. Pilocarpine, atropine and anticholinesterases
J Oral Ther Pharmacol
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This research was supported by a grant from Pharmacia Canada.