Prophylaxis of radiogenic sialadenitis and mucositis by coumarin/troxerutine in patients with head and neck cancer--a prospective,randomized, placebo-controlled, double-blind study.

K A Grötz, P Wüstenberg, R Kohnen, B Al-Nawas, H H Henneicke-von Zepelin, A Bockisch, J Kutzner, B Naser-Hijazi, G G Belz, W Wagner

Journal: The British journal of oral & maxillofacial surgery 2001;39(1):34-9

PMID: 11178853

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Abstract

OBJECTIVE

To study the efficacy of coumarin/troxerutine for the protection of salivary glands and mucosa during irradiation.

DESIGN

Prospective, randomized, placebo-controlled, double-blind trial.

SETTING

University hospital, Germany.

PATIENTS

48 patients who had radiotherapy to the head and neck.

MAIN OUTCOME MEASURES

Salivary gland scintigraphy and acute side-effects of radiotherapy (Radiation Therapy Oncology Group (RTOG) score).

RESULTS

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).

CONCLUSION

The results suggest that coumarin/troxerutine have a favourable effect in the treatment of radiogenic sialadenitis and mucositis.

Address: Oral and Maxillofacial Surgery, University of Mainz, Germany. [email protected]

DOI: 10.1054/bjom.2000.0459

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MeSH Terms: 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