Double-blind, randomized, parallel-group study on the efficacy and safety of oral granisetron and oral ondansetron in the prophylaxis of nausea and vomiting in patients receiving hyperfractionated total body irradiation

Spitzer, TR; Friedman, Carl J.; Bushnell, William D.; Frankel, SR; Raschko, James

doi:10.1038/sj.bmt.1702479

Cited by 59 publications

(34 citation statements)

References 25 publications

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“…13 Patients in the granisetron group had a 33.3% control of vomiting versus 26.7% control in the ondansetron group. Their conclusion was that more optimal therapy was needed.…”

Section: Resultsmentioning

confidence: 99%

Nausea and vomiting with high-dose chemotherapy and stem cell rescue therapy: a review of antiemetic regimens

Trigg

Inverso

2008

Bone Marrow Transplant

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Stem cell transplantation, using high-dose chemotherapy with or without TBI, is usually associated with significant nausea and vomiting. A variety of antiemetic regimens have been studied to control nausea and vomiting associated with the preparative therapy phase of SCT. We review the most significant studies and highlight the limitations of many of these studies. In addition, we review the few studies with the use of aprepitant as an antiemetic in combination with a 5HT 3 antagonist and a steroid. The American Society of Clinical Oncology guideline for antiemetic use for treatment regimens that are highly emetogenic is reviewed regarding recommendations for SCT preparative regimens. On the basis of this review of published data, we recommend the basic outline for an effective antiemetic investigational approach to the study and to the control of nausea and vomiting during the preparative phase of treatment for SCT.

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“…13 Patients in the granisetron group had a 33.3% control of vomiting versus 26.7% control in the ondansetron group. Their conclusion was that more optimal therapy was needed.…”

Section: Resultsmentioning

confidence: 99%

Nausea and vomiting with high-dose chemotherapy and stem cell rescue therapy: a review of antiemetic regimens

Trigg

Inverso

2008

Bone Marrow Transplant

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“…19 For patients receiving high-dose chemotherapy or chemo/ radiotherapy regimens in association with hematopoietic stem cell support, a number of studies suggest that antiemetic control may be a greater challenge in this setting. 17,[20][21][22][23][24][25] In the current prospective trial, we have clearly demonstrated that despite the use of standard prophylactic treatments, antiemetic control is indeed suboptimal for patients receiving allogeneic or autologous hematopoietic stem cell transplants and appears to be inferior to the results obtained with standard-dose chemotherapy. Limitations of the study include the diverse conditioning regimens, antiemetic treatments, and small sample size.…”

Section: Discussionmentioning

confidence: 91%

Prospective evaluation of antiemetic outcome following high-dose chemotherapy with hematopoietic stem cell support

Ballen

Hesketh

Heyes

et al. 2001

Bone Marrow Transplant

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Summary:Considerable progress has been made in improving the control of chemotherapy-induced emesis. The impact of available antiemetic options for patients receiving stem cell transplants is unclear, as few prospective data have been collected. We prospectively evaluated antiemetic outcome in patients receiving stem cell transplantation over a 7-day period following the initiation of chemotherapy. The primary endpoints were the number of emetic episodes and the extent of nausea measured on a four-point scale. Eighty-two patients were evaluated. Ninety-five percent of patients had nausea during the first week of treatment; 80% had at least one emetic episode. The percentage of patients with emesis was as follows: day 1: 13%, day 2: 21%, day 3: 30%, day 4: 38%, day 5: 44%, day 6: 39%, day 7: 18%. In multivariate analysis, gender, emesis with prior chemotherapy, history of morning or motion sickness, type of transplant (auto vs allo), use of total body irradiation, or use of dexamethasone did not effect emesis control. Most patients receiving high-dose chemotherapy experience incompletely controlled emesis. Control of nausea and emesis progressively worsened with each subsequent day following initiation of chemotherapy, reaching a nadir on day 5. New treatment approaches are needed to improve emesis control in this patient population. Bone Marrow Transplantation (2001) 28, 1061-1066. Keywords: nausea; bone marrow transplantation Myeloablative chemotherapy and radiotherapy followed by autologous or allogeneic stem cell transplantation have been shown to be curative for certain hematologic malignancies, aplastic anemia, and genetic disorders. 1-3 Over the last three decades of transplantation, there have been significant advances in supportive management to lessen tox- icity and improve tolerance of autologous and allogeneic stem cell transplantation. [4][5][6][7] From the patient's standpoint, two of the most feared adverse effects of chemotherapy are treatment-induced nausea and vomiting. 8,9 Considerable progress has been made in the control of nausea and vomiting for patients receiving standard doses of chemotherapy. The use of 5-hydroxytryptamine-3 (5HT3) antagonists, such as dolasetron, granisetron and ondansetron, have contributed significantly to the control of nausea and vomiting in patients receiving moderately and highly emetogenic chemotherapy. [10][11][12][13] The great majority of patients receiving emetogenic chemotherapy at standard doses should achieve complete control of emesis at the present time.A number of patient and treatment-related factors predictive for the development of chemotherapy-induced emesis have been defined. These include age, gender, ethanol consumption history, and the intrinsic emetogenicity of the chemotherapy agents. 14 Also of importance is chemotherapy dose. The emetogenicity of a number of chemotherapy agents such as cisplatin and cyclophosphamide increases with increasing dose. 15 The outcome of antiemetic therapy has not been well studied in the setting of highdose chemo...

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“…A retrospective study of ondansetron in the ED reported that 38% (n = 12,620) of prescriptions were for reasons other than gastroenteritis in the ED. 15 Other indications of ondansetron are post-operativem, [44][45][46] chemotherapy, radiotherapy, 47,48 sedation, 49 or during pregnancy. 50 Recently, ondansetron has been prescribed for brain-related diseases like obsessive-compulsive disorders 51 or drug/alcohol addictions, [52][53][54] suggesting that it may influence other symptoms than vomiting.…”

Section: Discussionmentioning

confidence: 99%

Ondansetron for pediatric concussion; a pilot study for a randomized controlled trial

Gravel

Carrière

D’Angelo

et al. 2016

CJEM

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Objectives: Assess the feasibility of a study evaluating one dose of oral ondansetron to decrease post-concussion symptoms at one week and one month following concussion in children aged 8 to 17 years old. Method: This was a pilot study for a randomized, triple-blind controlled trial of one dose of either ondansetron or placebo performed in a tertiary care pediatric emergency department. Participants were children aged 8 to 17 years who sustained a concussion in the previous 24 hours and visited a single emergency department. The outcome of interest was an increase from pre-concussion baseline of at least 3 symptoms from the Post-Concussion Symptom Inventory, measured at one week and at one month following concussion. The primary outcome was to determine the proportion of children who completed the assessment at one week following the intervention. Secondary outcome was the proportion of children who completed the assessment at one month following the intervention. All children, care givers, and those assessing the outcomes were blinded to the group assignment. Results: Of the 218 children presenting with a concussion during the study period, we screened 108 and found 36/108 (33%) eligible to participate and 16/108 (14.8%) agreed to participate. All enrolled patients were compliant with the intervention and follow-up. Conclusion: In our study population, approximately one-third of the screened concussion patients were eligible to participate and approximately one half of those eligible agreed to participate. Our study found that most enrolled patients preferred electronic follow-up; the noncompliance rate was minimal.

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Double-blind, randomized, parallel-group study on the efficacy and safety of oral granisetron and oral ondansetron in the prophylaxis of nausea and vomiting in patients receiving hyperfractionated total body irradiation

Cited by 59 publications

References 25 publications

Nausea and vomiting with high-dose chemotherapy and stem cell rescue therapy: a review of antiemetic regimens

Nausea and vomiting with high-dose chemotherapy and stem cell rescue therapy: a review of antiemetic regimens

Prospective evaluation of antiemetic outcome following high-dose chemotherapy with hematopoietic stem cell support

Ondansetron for pediatric concussion; a pilot study for a randomized controlled trial

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