Hadad P, Karimi M,
Volume 60, Issue 1 (13 2002)
Abstract
Xerostomia is one of the disturbing side-effects of the radiotherapy to the head and neck region. Pilocarpine has been approved for the treatmentof this condition in the chronic phase, but its use concurrent with radiation could also be beneficial for prevention or reducing the subsequent radiation-induced xerostomia. We undertook to test this hypothesis in a clinical trial.
Materials and Methods: All 18- to 70-year old patients who were to be irradiated to the head and neck, with both parotid glands in the radiation fields, were eligible for this study. Patients with any medical contraindications for pilocarpine were excluded. Randomization was performed at the start of radiotherapy to either pilocarpine 5 mg three times daily or placebo in a double-blind setting. The drug was started with irradiation and continued until 3 months after the end of radiotherapy. Serum pilocapine levels were measured in a randomly selected number of patients by high-pressure liquid chromatography (HPCL). Xerostomia was evaluated about 6 months after the end of radiation by an analog-scale questionnaire, and the objective grading of xerostomia was recorded by two separate observers.
Results: A total number of 60 patients were randomized into the trial (31 pilocarpine, 29 placebo), mostly with nasopharyngeal carcinomas. Mean parotid dose was 5, 818 cGy. Mean pilocarpine serum level was 14.65 ng/ml. No serous side-effect was observed. Thirty-nine patients were analyzed for xerostomia at a median time of 7 months after radiotherapy, 18 in pilocarpine and 21 in placebo groups (9 patients died and 12 patients did not come back for xerostomia evaluation). Mean subjective xerostomia was 40.3 mm in the pilocarpine group and 57 mm in the placebo group (p= 0.02). Also mean objective xerostomia grade was 2.2 in the pilocarpine group and 2.6 in the placebo group (p= 0.01). Subjective and objective xerostomia results were positively correlated (level 0.01). Age and the parotid dose did not have a significant effect on xerostomia.
Conclusion: Pilocarpine as prescribed in our trial produced the standard serum level required, and no serious side-effect. Compared to polacebo, pilocarpine used with radiotherapy could lead to a diminishment of subsequent radiation-induced xerostomia.
Fotouhi M, Samee F, Amoozegar Hashemi F, Hadad P, Meysami A P,
Volume 65, Issue 3 (2 2007)
Abstract
Background: Acute radiation dermatitis is a very common side effect of radiation therapy for many cancers, including breast cancer. Despite the high prevalence of acute radiation dermatitis as well as wet desquamation, only a few trials studying the prophylaxis of this complication using topical treatment have been conducted. In spite of these studies, some controversy still exists about regarding treatments for acute radiation dermatitis, as does some concern about their long-term complications. For this reason, we conducted a clinical trial for a new treatment with the same effectiveness as corticosteroids, but fewer complications.
Methods: This trial included 60 patients with pathologic diagnoses of breast cancer for whom radiotherapy had been planned. Patients were 30-73 years old. Patients with radical mastectomy received 5000 cGy over five weeks, and those with conservative surgery received 6000 cGy over six weeks divided in 200 cGy fractions. Patients were divided randomly into two groups: one group received a moderately-potent glucocorticoid steroid, 0.1% betamethasone ointment (30), and the other received the new treatment, 0.1% calendula ointment (30). All patients applied their respective drugs twice daily within the tangential field from the first day of radiation treatment until one month after treatment was completed. Starting one week after radiation therapy commenced, patients were monitored weekly for symptoms of dermatitis and the degree of severity as well as possible adverse drug effects, in addition to such monitoring on the days of their appointments. Four weeks after termination of therapy, patients were again examined, at which time they completed a questionnaire about dermatologic complications.
Results: The mean time to develop dermatitis was 3.7 weeks for the betamethasone group and 3.87 weeks for the calendula group. Maximal dermatitis intensity during treatment in the betamethasone group was: 0, 6.7% I, 73.3% II, 16.7% III, 0% IV, 3.3%. Dermatitis intensity in the calendula group was: 0, 13.3% I, 67% II, 16.7% III, 0% IV, 3.3%. No significant differences were observed in the incidence of symptoms such as burning, pruritus and pain between the two groups (p=0.762).
Conclusion: Calendula ointment is as effective as betamethasone in reducing acute radiation dermatitis.
