Comparison of tropisetron and chlorpromazine combinations in the control of nausea and vomiting in patients with advanced cancer

This single-institution, prospective, randomized trial was performed to evaluate the efficacy of tropisetron and chlorpromazine in the management of nausea and vomiting of terminal cancer patients. Patients had no recent chemotherapy or radiotherapy, and emesis was not due to bowel obstruction, electrolytic or metabolic disturbances, drug intake, or intracranial disease. One hundred and sixty patients randomly received either (a) chlorpromazine (CLO) (50 mg/day) plus dexamethasone (DEX) (2 mg/day), (b) chlorpromazine (25 mg/day) plus tropisetron (TRO) (5 mg/day), (c) chlorpromazine (25 mg/day) plus tropisetron (5 mg/day) plus dexamethasone (2 mg/day), or (d) tropisetron (TRO) (5 mg/day). Patients were monitored from day 1 to day 15. No nausea or vomiting was defined as 'total' control. On day 15, total vomiting control was achieved in 33.3% of the patients receiving CLO + DEX, 84.6% of the patients receiving CLO + TRO, 92.5% of the patients receiving CLO + TRO + DEX, and 78.9% of the patients receiving TRO. Total control of nausea was achieved in 18.0% of the patients receiving CLO + DEX, 74.4% of the patients receiving (CLO + TRO), 85.0% of the patients receiving CLO + TRO + DEX, and 65.8% of the patients receiving TRO. Tropisetron-containing combinations produced significant control of nausea and vomiting from the third day onward. All antiemetic drugs were well tolerated. These data suggest that tropisetron-containing combinations or tropisetron as a single agent are much more effective in the control of emesis in patients with advanced cancer than the conventional antiemetic combination of chlorpromazine plus dexamethasone. Tropisetron is well tolerated and may be the best choice for controlling persistent nausea and vomiting in terminal cancer patients

Comparison of the efficacy and safety of tropisetron, metoclopramide, and chlorpromazine in the treatment of emesis associated with far advanced cancer

BACKGROUND. A single institution, prospective, randomized trial was performed in terminal cancer patients to compare tropisetron (TRO), metoclopramide (MET), and chlorpromazine (CHL) in the management of nausea and emesis. Patients had far advanced cancer, were far removed from chemotherapy or radiotherapy, and their nausea and emesis was not due to bowel obstruction, drug intake, or cranial, electrolytic, or metabolic causes. The effects of antiemetic treatments were evaluated from Days 1-15. METHODS, Two hundred and eighty patients were randomized to receive 1) MET+ dexamethasone (DEX) (10 mg*4 and 2 mg*1, respectively, orally), 2) TRO (5 mg*1, orally), 3) TRO + MET (5 mg*1 and 10 mg*2, respectively, orally), 4) TRO + MET + DEX (5 mg*1, 10 mg*2, and 2 mg*1, respectively, orally), 5) CHL + DEX (25 mg*2 and 2 mg*1, respectively, orally), 6) TRO + CHL (5 mg*1 and 12.5 mg*2, respectively, orally), or 7) TRO + CHL + DEX (5 mg*1, 12.5 mg*2, and 2 mg*1, respectively, orally). Total control was defined as no nausea or emesis. RESULTS. By the end of the 15th day, total control of emesis was obtained in 23.6% (9 of 38) of MET + DEX patients, 78.9% (30 of 38) of TRO patients, 84.2% (32 of 38) of TRO + MET patients, 92.3% (36 of 39) of TRO + MET + DEX patients, 33.3 (13 of 39) of CHL + DEX patients, 84.6% (33 of 39) of TRO + CHL patients, and 92.5% (37 of 40) of TRO + CHL + DEX patients. Total control of nausea was achieved in 18.4% (7 of 38) of MET + DEX patients, 65.7% (25 of 38) of TRO patients, 73.6% (28 of 38) of TRO + MET patients, 87.1% (34 of 39) of TRO + MET + DEX patients, 17.9% (7 of 39) of CHL + DEX patients, 74.3% (29 of 39) of TRO + CHL patients, and 85% (34 of 40) of TRO + CHL + DEX patients. When comparing MET + DEX versus TRO; MET + DEX versus TRO + MET; MET + DEX versus TRO + MET + DEX; MET + DEX versus TRO + CHL; MET + DEX versus TRO + CHL + DEX; CHL + DEX versus TRO; CHL + DEX versus TRO + MET; CHL + DEX versus TRO + MET + DEX; CHL + DEX versus TRO + CHL; and CHL + DEX versus TRO + CHL + DEX, significant differences were noted. All antiemetic drugs were well tolerated with no severe side effects observed in any treatment arm. CONCLUSIONS. These data suggest that 5-HT3 receptor antagonists such as tropisetron clinically are more effective in the control of emesis of patients with far advanced cancer than previously used agents. This study raises important issues when attempting to decide which antiemetic therapy to choose for an individual patient with far advanced disease. (C) 1998 American Cancer Society

Quality of life as a parameter determining therapeutic choices in cancer care in a Greek sample

Health-related quality of life (HRQL) is difficult to define and measure. It is a generic term that includes concepts such as physical health, life satisfaction, psychological well-being and self-integrity. Realizing and appreciating the importance of HRQL is crucial for physicians ii they are to be in a position to offer appropriate suggestions in assisting patients and their families in the decision-making process regarding cancer treatment and terminal care. In order to determine whether Greek physicians take into consideration HRQL when assessing different therapeutic options, we conducted a postal survey. A total of 1500 Greek physicians (internists, oncologists and anaesthesiologists) were asked to complete a questionnaire. We received replies from 1280 (85%). in summary, we found that Creek physicians: (1) have already started taking HRQL into consideration when reviewing their therapeutic options; (2) increasingly include HRQL in research studies as an outcome measure; (3) do not yet have thoroughly sufficient training in the holistic care of cancer patients and their families; (4) mostly do not have the opportunity to work in interdisciplinary therapeutic teams where they can exchange ideas and consider different aspects of alternative therapeutic methods. It is concluded that HRQL has already been introduced as an important determinant of therapeutic choices in cancer care in Greece. However, efforts need to be made to allow HRQL to enjoy its appropriate place in cancer care

Use of TTS fentanyl as a single opioid for cancer pain relief: A safety and efficacy clinical trial in patients naive to mild or strong opioids

Background. Up to now, a transdermal therapeutic system (TTS) of fentanyl has been applied to cancer patients on opioid analgesics previously treated with mild opioids or morphine. The aim of this study was to investigate the efficacy and safety of TTS fentanyl (patch) administration as an analgesic to patients treated with opioid analgesics for moderate-to-severe cancer pain, with immediate-release oral morphine only as rescue medication. The prior analgesic medication of the patients did not include mild or strong opioids. Methods., The study group consisted of 113 patients (54 men and 59 women; age range: 21-87 years, mean +/- SD 61.3 +/- 14.84 years) with undertreated chronic cancer pain. The study period was 42 days. The patients were hospitalized for the first 3 days of the study; thereafter they were transferred to their home for the rest of the study. Daily cards were completed, noting their pain score (0-10 VAS), nausea, vomiting, constipation, skin reactions, dizziness or any other complaints. Vital signs were also recorded. Data assessments were made at baseline, on days 1, 2 and 3 (during hospitalization) and thereafter on days 7, 14, 21, 28, 35, and 42 after hospital discharge. The initial TTS fentanyl delivery rate was chosen depending on the patient’s analgesic requirements. All patients were given an oral morphine solution (5-10 mg), every 4-6 h, for the first 12 h, as rescue medication. Results: Baseline pain score was between 6 and 10 (mean SD 7.1 +/- 1.7). The initial TTS fentanyl delivery rate was between 25 and 50 mug/h (mean +/- SD 36.5 +/- 15.7). On day 3, 95 patients (84%) reported a pain score less than or equal to3 (mean +/- SD 0.5 +/- 0.8), 14 patients (12.4%) a pain score of 4 and 4 patients (3.5%) of 5-8. No adverse effects suggesting the discontinuation of the study were reported. From day 7 until the completion of the study, the mean pain score was between 1.3 and 0.16 while the TTS fentanyl delivery rate on day 42 was between 25 and 400 mug/h (mean +/- SD 122.1 +/- 81.2 mug/h). Conclusion: Analgesic treatment with TTS fentanyl used as a single opioid is effective and safe for cancer pain relief, given that is cautiously applied, in patients requiring strong opioid analgesics even if they were naive to strong or mild opioids. Copyright (C) 2002 S. Karger AG, Basel

Tropisetron versus Metoclopramide in the control of emesis in far-advanced cancer

The present study was conducted to assess the optimum treatment for nausea and vomiting in patients with far advanced cancer. More specifically, we studied patients with cancers that were too far advanced to benefit from chemotherapy or radiotherapy and whose nausea and vomiting were not due to drug intake, cranial, electrolytic, or metabolic causes. One hundred twenty patients who were under antiemetic medication with metoclopramide (MET) and suddenly presented with uncontrolled nausea and vomiting were randomized to three different therapeutic regimens: MET plus dexamethasone (DEX), MET plus tropisetron (TRO), and MET plus TRO plus DEX. Patient diary cards were used to assess nausea and vomiting. By the end of day 15, total control of vomiting was achieved in 24% of MET plus DEX patients, in 84% of MET plus TRO patients, and in 92% of MET plus TRO plus DEX patients. Total control of nausea was achieved in 18% of MET plus DEX patients, in 74% of MET plus TRO patients, and in 87% of MET plus TRO plus DEX patients. All antiemetic treatments were similarly well tolerated. TRO in combination with either MET or MET and DEX produced the best control of both nausea and vomiting

Continuous subcutaneous administration of high-dose salmon calcitonin in bone metastasis: Pain control and beta-endorphin plasma levels

This prospective nonrandomized trial was performed to evaluate the efficacy of salmon calcitonin (sCT) in controlling pain related to bone metastasis in cancer patients and the relation of sCT's analgesic efficacy with beta-endorphin blood levels. The study group consisted of 22 cancer patients with bone metastases (male 13 and female 9, age range 38-77 years). Pain control was first achieved by continuous subcutaneous (sc) morphine administration. The next increase in pain was managed with continuous sc administration of 400 IU/day sCT. Beta-endorphin blood levels were measured before and during sCT administration. The first measurement was taken before sCT administration; subsequent measurement occurred at 12, 24, and 48 hours and 7 days after the commencement of treatment. Pain scores were monitored by a visual analogue scale. A complete blood count and a biochemical screening profile were taken before the administration of calcitonin and also on the seventh and the fifteenth day of the administration. The results showed a satisfactory analgesic effect. The mean pain score before the calcitonin administration was 4.43 and the score on the seventh day was 1.17. The gradual reduction of pain score was associated with an increase in beta- endorphin blood levels (increase to 147.2% of baseline on the seventh treatment day). In three cases, no satisfactory analgesic effect was obtained and pain control was achieved by increasing the continuous sc morphine dosage. No significant side effects were observed. These data suggest that sCT in high doses may be a useful adjuvant analgesic when combined with low doses of morphine in continuous sc administration for the management of metastatic bone pain

Tropisetron versus metoclopramide in the control of emesis in far- advanced cancer

The present study was conducted to assess the optimum treatment for nausea and vomiting in patients with far advanced cancer. More specifically, we studied patients with cancers that were too far advanced to benefit from chemotherapy or radiotherapy and whose nausea and vomiting were not due to drug intake, cranial, electrolytic, or metabolic causes. One hundred twenty patients who were under antiemetic medication with metoclopramide (MET) and suddenly presented with uncontrolled nausea and vomiting were randomized to three different therapeutic regimens: MET plus dexamethasone (DEX), MET plus tropisetron (TRO), and MET plus TRO plus DEX. Patient diary cards were used to assess nausea and vomiting. By the end of day 15, total control of vomiting was achieved in 24% of MET plus DEX patients, in 84% of MET plus TRO patients, and in 92% of MET plus TRO plus DEX patients. Total control of nausea was achieved in 18% of MET plus DEX patients, in 74% of MET plus TRO patients, and in 87% of MET plus TRO plus DEX patients. All antiemetic treatments were similarly well tolerated. TRO in combination with either MET or MET and DEX produced the best control of both nausea and vomiting