Dose comparison of tropisetron (Navoban) 5 mg and 10 mg orally in the prophylaxis of dacarbazine-induced nausea and emesis.
In this double-blind, randomized trial performed at five study centers, the prophylactic, antiemetic effect of two different dosages of tropisetron (Navoban; Sandoz Pharma Ltd, Basel, Switzerland) was investigated in dacarbazine-treated patients with melanoma. Patients received tropisetron 5 mg or 10 mg orally (as one capsule) once daily (minimum 3 days) on each day of chemotherapy. No significant differences were found in the effects of tropisetron 5 mg and 10 mg. During the first 24 hours, total control of vomiting was seen in 93% and 98% of patients receiving tropisetron 5 mg and 10 mg, respectively. Total control of nausea was achieved in 84% and 80% of patients receiving tropisetron at these dosages. Over days 2 to 7 of chemotherapy, total control of vomiting and nausea remained high. Patients reported that quality of life remained good throughout chemotherapy, as did mood; only a small decrease in food intake occurred. Tropisetron was well tolerated. Constipation was the most common adverse event, occurring in 13% of patients. Headache (4%), diarrhea (4%), and anorexia (2%) also were observed.
Garbe
C
C
Department of Dermatology, University Medical Center Steglitz, Free University Berlin, Germany.
Drechsler
S
S
Fiedler
H
H
Tilgen
W
W
Landthaler
M
M
Schroeder
K
K
Kuehne
K H
KH
Faerber
L
L
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000008:administration & dosage* / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000009:adverse effects; D003606:Dacarbazine / Q000009:adverse effects; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007211:Indoles / Q000008:administration & dosage* / Q000627:therapeutic use; D008297:Male; D008545:Melanoma / Q000188:drug therapy*; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control; D011788:Quality of Life; D012702:Serotonin Antagonists / Q000008:administration & dosage* / Q000627:therapeutic use; D000077526:Tropisetron; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control
D000932:Antiemetics; D000970:Antineoplastic Agents; D007211:Indoles; D012702:Serotonin Antagonists; D000077526:Tropisetron; D003606:Dacarbazine