Oral medicine
Double-blind randomized, placebo-controlled study of pilocarpine to salvage salivary gland function during radiotherapy of patients with head and neck cancer

https://doi.org/10.1016/j.tripleo.2004.04.009Get rights and content

Abstract

Objective

The efficacy of pilocarpine given during radiotherapy for head-neck cancer to reduce xerostomia was assessed.

Study design

58 patients receiving 5000 cGy radiotherapy (RT) involving salivary glands bilaterally were selected at the Jewish General Hospital, Montreal, Canada. Patients were randomly assigned to pilocarpine (5 mg, PILO, n = 29) or placebo group (PLA, n = 29). These drugs were taken 5 times daily during radiotherapy (first study phase) and 4 times daily for 5 weeks thereafter (second study phase). Saliva was collected and estimated for not stimulated and stimulated patients using the SAXON method.

Results

At the conclusion of the first phase, PILO patients reported a better global quality of life (P = .02) and less oral discomfort (P = .001) when compared to PLA. No significant difference was noted in the level of saliva, xerostomia, and other symptoms between patients in PILO and PLA. At the end of the second phase, a difference between groups was observed only for xerostomia and mucosal pain; both were significantly higher in PILO when compared to PLA (P < .05).

Conclusion

Pilocarpine 5mg given 5 times daily did not appear to improve the production of saliva and global quality of life assessments, nor to decrease the symptoms of xerostomia 5 weeks after completion of RT in patients who were taking pilocarpine post-RT. There was a slight improvement in the quality of life and a decrease in the level of discomfort noted only after the first study phase. The limitations of this study are discussed.

Section snippets

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

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    This research was supported by a grant from Pharmacia Canada.

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