troxerutin and Xerostomia

To study the efficacy of coumarin/troxerutine for the protection of salivary glands and mucosa during irradiation.. Prospective, randomized, placebo-controlled, double-blind trial.. University hospital, Germany.. 48 patients who had radiotherapy to the head and neck.. Salivary gland scintigraphy and acute side-effects of radiotherapy (Radiation Therapy Oncology Group (RTOG) score).. 23 patients (11 experimental, 12 placebo) completed the study. The global efficacy measure combining scintigraphy and RTOG score favoured the experimental arm (P=0.07). The RTOG score showed significantly fewer acute side-effects of radiation in the experimental arm (P<0.05).. The results suggest that coumarin/troxerutine have a favourable effect in the treatment of radiogenic sialadenitis and mucositis.

Topics: Adult; Aged; Coumarins; Cranial Irradiation; Double-Blind Method; Drug Combinations; Female; Head and Neck Neoplasms; Humans; Hydroxyethylrutoside; Male; Middle Aged; Mouth Mucosa; Prospective Studies; Radiation Injuries; Radiation-Protective Agents; Radionuclide Imaging; Radiopharmaceuticals; Salivary Glands; Sialadenitis; Sodium Pertechnetate Tc 99m; Treatment Outcome; Xerostomia

Prospective, randomized placebo-controlled double-blind study to prove the efficacy of Coumarin/Troxerutine (Venalot Depot) for protection of salivary glands during a head and neck irradiation.. Forty-eight radiotherapy patients (60 Gy) with head and neck cancer were included in this trial. During radiotherapy the salivary glands were located in the core irradiation field. Primary efficacy parameters were sialometry, quantitative salivary gland scintigraphy and clinical evaluation of early effects of radiotherapy (RTOG-score, Table 1). All data were collected at 6 assessments: 1 week pre-radiation (U1), at start (U2), half time (U3) and end (U4) of irradiation, 8 days (U5) and 28 days (U6) after the end of irradiation (Figure 1).. Twenty-three patients (11 verum, 12 placebo) completed the study with all assessments. Sialometrically, all patients were severely (half of radiotherapy) or completely (end of radiotherapy) xerostomatic (Figure 2). In a global efficacy measure according to O'Brien combining scintigraphy and RTOG there was a tendency for a higher efficacy of verum compared to placebo (p = 0.068). After start of irradiation therapy, the RTOG-score showed continuously and significantly lower early radiation effects under verum than under placebo (U3 vs U6: p < 0.05, area under curve: p = 0.032; Table 2, Figure 3). The scintigraphically determined excretion fraction was slightly less impaired in the verum group compared to the placebo treatment (p = 0.12. Figure 4). There was no difference in drug safety between placebo and verum for adverse events, changes in the activity of liver enzymes and for global impression of tolerability.. The results give support for an advantageous effect of Venalot Depot in the treatment of radiogenic sialadenitis and mucositis. In even a small number of evaluable patients, early clinical effects of irradiation (RTOG-score) were less pronounced in the active treatment group than in the placebo group, but the sample size was too low to prove statistically also the benefit of coumarin/troxerutine with the scintigraphic method. Sialometry seems not suitable for the assessment of early radiation effects.

Topics: Adult; Aged; Coumarins; Double-Blind Method; Drug Therapy, Combination; Female; Head and Neck Neoplasms; Humans; Hydroxyethylrutoside; Male; Middle Aged; Mouth Mucosa; Prospective Studies; Radiation Injuries; Radiation-Protective Agents; Radiotherapy; Salivation; Treatment Outcome; Xerostomia