Prophylaxis of radiogenic sialadenitis and mucositis by coumarin/troxerutine in patients with head and neck cancer--a prospective,randomized, placebo-controlled, double-blind study.
OBJECTIVE
To study the efficacy of coumarin/troxerutine for the protection of salivary glands and mucosa during irradiation.


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


METHODS
University hospital, Germany.


METHODS
48 patients who had radiotherapy to the head and neck.


METHODS
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).


CONCLUSIONS
The results suggest that coumarin/troxerutine have a favourable effect in the treatment of radiogenic sialadenitis and mucositis.
Grötz
K A
KA
Oral and Maxillofacial Surgery, University of Mainz, Germany. groetz@mkg.klinik.uni-mainz.de
Wüstenberg
P
P
Kohnen
R
R
Al-Nawas
B
B
Henneicke-von Zepelin
H H
HH
Bockisch
A
A
Kutzner
J
J
Naser-Hijazi
B
B
Belz
G G
GG
Wagner
W
W
D000328:Adult; D000368:Aged; D003374:Coumarins / Q000627:therapeutic use*; D016371:Cranial Irradiation / Q000009:adverse effects*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006258:Head and Neck Neoplasms / Q000532:radiotherapy; D006801:Humans; D006896:Hydroxyethylrutoside / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa / Q000528:radiation effects; D011446:Prospective Studies; D011832:Radiation Injuries / Q000517:prevention & control*; D011837:Radiation-Protective Agents / Q000627:therapeutic use*; D011877:Radionuclide Imaging; D019275:Radiopharmaceuticals; D012469:Salivary Glands / Q000000981:diagnostic imaging; D012793:Sialadenitis / Q000209:etiology / Q000517:prevention & control*; D013670:Sodium Pertechnetate Tc 99m; D016896:Treatment Outcome; D014987:Xerostomia / Q000209:etiology / Q000517:prevention & control
D003374:Coumarins; D004338:Drug Combinations; D006896:Hydroxyethylrutoside; D011837:Radiation-Protective Agents; D019275:Radiopharmaceuticals; C013731:Venalot; C005865:troxerutin; D013670:Sodium Pertechnetate Tc 99m