BACKGROUNDClinical reports suggest that nausea remains a side effect of chemotherapy despite widespread use of serotonin receptor antagonists. This study summarized the frequency, timing, and intensity of postchemotherapy nausea for patients receiving doxorubicin, cisplatin, or carboplatin.METHODSThree hundred sixty chemotherapy‐naïve patients (73% female) were enrolled in a study testing the ability of an information intervention to reduce nausea. Of these, 322 subjects completed the Morrow Assessment of Nausea and Emesis (MANE), as well as a 5‐day self‐report diary, at Cycle 1 (300 subjects completed the MANE and self‐report diary at Cycle 2). All patients received a 5‐hydroxytryptamine‐3 receptor antagonist (ondansetron) with dexamethasone on the day of treatment.RESULTSSeventy‐six percent of the patients developed nausea during the 5‐day period, beginning with the Cycle 1 infusion, and 73% of patients reported delayed nausea (DN) during Days 2–5. The proportions were similar during Cycle 2. Fifty‐five percent of patients described their DN as being of moderate or greater intensity compared with 28% of patients who described acute nausea. Carboplatin was less likely to cause DN than either of the other agents (56% of 106 patients compared with 75% of 47 receiving cisplatin and 83% of 169 taking doxorubicin). The mean peak DN severity was 4.34 (range, 1–7) for doxorubicin, which was significantly higher than the mean peak value for carboplatin (3.66) but was not significantly different from the mean peak value for cisplatin (4.26). Eighteen percent of patients did not experience nausea until Day 3 or later.CONCLUSIONSDespite prophylaxis with ondansetron, the majority of patients receiving one of these common chemotherapy agents experienced nausea. The frequency of DN was nearly twice that of acute nausea. Results show the need for continued development of antiemetics that are effective against DN. Cancer 2003;97:2880–6. © 2003 American Cancer Society.DOI 10.1002/cncr.11408
Background. Nausea and vomiting are the most distressing side effects associated with the administration of chemotherapy for neoplastic diseases. Nausea, in particular, often had been ignored in studies of chemotherapy side effects. Recently, progress has been made in the control of chemotherapy‐induced nausea and vomiting, due, in part, to a better understanding of the physiologic mechanisms involved. Methods. This paper reviews recent advances in the control of emesis, focusing on pharmacologic treatments. Results. The efficacy and safety of the serotonin (5‐HT3) receptor antagonists granisetron, ondansetron, and tropisetron in the control of acute and delayed emesis and emesis induced by repeat‐cycle chemotherapy are summarized. Although differences in study design and definitions of response criteria have made it difficult to compare the studies that have evaluated these three agents, the overall body of literature supports several clinical findings. Conclusions. (1) The 5HT3 antiemetic agents have been shown to be clinically more effective in the control of nausea and emesis than previously used agents. (2) No one of the three has demonstrated consistently greater efficacy. (3) Efficacy appears to be more pronounced for cisplatin‐containing regimens than for moderate or less emetogenic chemotherapy regimens. (4) Effectiveness of the 5HT3 agents appears to be less for delayed nausea and emesis than for acute symptoms. Potential control of anticipatory nausea and emesis has not been investigated. (5) Control over nausea appears to be significantly less than control over emesis. In the studies in which it has been measured, nausea control remains incomplete for approximately half the patients given 5HT3 agents. (6) The efficacy of the agents appears to diminish across repeated days and, perhaps, across repeated chemotherapy cycles. (7) The addition of a steroid such as dexamethasone increases the efficacy of both 5HT3 and other antiemetic agents. This effect also seems to apply to delayed nausea and emesis Cancer 1995;76:343–57.
BACKGROUNDPatients may use their past experiences with nausea, as well as information about the incidence of nausea from chemotherapy that other patients have experienced, to form a prediction, or response expectancy, of nausea from their own upcoming chemotherapy. Mounting evidence suggests that these expectancies relating to nausea are significant predictors, and, likely, contributing factors to the development of treatment‐related nausea.METHODSThe patients in the current study were participants in the control arm of a multicenter clinical trial conducted between November 1999 and July 2001 by the University of Rochester Community Clinical Oncology Program. All patients in the current report were age ≥ 18 years and were about to begin a first cancer treatment regimen containing doxorubicin.RESULTSExpectancy of nausea assessed before patients received their first doxorubicin‐based chemotherapy treatment was found to be a strong predictor of subsequent nausea and in fact was stronger than previously reported predictive factors, including age, nausea during pregnancy, and susceptibility to motion sickness. Women who believed it was “very likely” that they would have severe nausea from chemotherapy were five times more likely to experience severe nausea than fellow patients who thought its occurrence would be “very unlikely.”CONCLUSIONSFurther studies confirming an expectancy of nausea as a risk factor are warranted as are studies examining the benefit to a patient's quality of life from modifying antiemetic treatment guidelines to take into account symptom expectancies. Finally, ethically acceptable interventions that are designed to reduce patients' nausea expectancies or increase their expectancies of nausea control should be developed and studied. Cancer 2004. © 2004 American Cancer Society.
A less-than-optimal proportion of patients with cancer are entered into National Cancer Institute-sponsored clinical trials. This article reviews the literature on accrual in oncology clinical trials to characterize the extent of the problem, identify reasons for low accrual, and suggest ways to promote accrual. Four well known theories of health behavior (the Health Belief Model, Subjective Expected Utility Theory, Protection Motivation Theory, and the Theory of Reasoned Action) point to central concepts involved in understanding patient health-related behavior: (1) the probability that an unwelcomed health event will happen to a patient, (2) the severity of that event if it does occur, (3) the effectiveness of a particular behavior (such as taking part in a clinical trial) to modify the severity, and (4) the cost of adopting that behavior. These concepts form a framework for integrating the available information about accrual to clinical oncology trials. Patient and physician factors previously related to clinical trials suggest specific recommendations for increasing accrual to clinical oncology trials. Cancer 1994;742676-82.
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