[Effects of an anti-emetic tropisetron capsule on QOL of patients with delayed nausea and vomiting induced by cancer chemotherapy. Group for Investigation of QOL Questionnaire for Anti-Emetics used in Cancer Chemotherapy. Joint Research Group for Tropisetron Double-Blind Comparative Study].

We have reported our "new questionnaire of QOL (quality of life) in anti-emetic therapies during cancer chemotherapy" and demonstrated its reliability and validity. In the present study we investigated the utility of tropisetron capsules for delayed nausea and vomiting induced by cancer chemotherapies with CDDP single administration in a placebo-controlled double-blind comparative study using the questionnaire. The questionnaire was composed of the following scales: a physiological scale (appetite, feeling, vomiting, nausea), a psychological scale (sleep, mental fatigue, anxiety, pain, abdominal condition), a respiratory condition related scale (sputum, respiratory distress), an active scale (daily life in a hospital), a social relation scale (understanding of the family), a linear analogue scale for evaluation of the influence of nausea and vomiting in patient's life during 24 hours, and a face scale as the global scale. First, all patients were administered a preventive dose of tropisetron capsule on day 1 (the day of CDDP administration) and then allotted to once-daily oral administration of either a tropisetron (T group) or a placebo (P group) capsule during days 2 to 5 by a double-blind method. Chronological changes of QOL during the study period were measured by the area under the curve (AUC) generally used for calculation of blood levels of drugs. The maximum fluctuation (Difmax) of QOL scores throughout the whole study period was also evaluated. The data were collected from 114 cases, and 98 cases (51 in P group, 47 in T group) were analyzed. 1) The total score or 13 items (a modified linear analogue scale with 5 graduations), the face scale and linear analogue scale of T group were higher (better) than those of P group. 2) As for the total score of each scale, the physiological, psychological and active scales in the T group showed higher (better) levels than the P group. 3) As for the AUC values, the T group was lower (better) than the P group in most items. In AUC of the total score of 13 items, the face scale, the physiological and the psychological scales, the T group was significantly superior to the P group. 4) AUC levels of each item belonged to the physiological and the psychological scales in the T group tended to be lower (better) than the P group, and "sleep" and "pain" in the psychological scale were significantly lower (better) in T group than P group. 5) In Difmax values, all scales except respiratory condition related scale showed lower levels (better) in T group and the total score of 13 items, the face scale and the physiological and psychological scales showed significantly lower levels than P group. 6) Difmax values in each item belonging to the physiological and psychological scales showed lower levels in the T group, while "appetite" and "vomiting" in the physiological scale and "sleep" in the psychological scale showed significantly lower levels (better) than those of the P group. 7) In the stratified analysis performed for patients without nausea and vomiting on the 1st day of chemotherapy, there was no significance in AUC levels of all items in both groups. In patients with nausea and vomiting on the 1st day, the total score of 13 items, the face scale, the physiological and the psychological scales in the T group were significantly better than in the P group. 8) It was suggested that the anti-emetic efficacy of tropisetron for delayed nausea and vomiting might reduce the undesirable influence of chemotherapy on QOL, especially on the physiological and the psychological effects. These results suggested that this new questionnaire is applicable for evaluation of the utility of anti-emetics in patients in cancer chemotherapy, and that tropisetron capsules could reduce the decrease of QOL in delayed nausea and vomiting induced by chemotherapy.