scholarly journals Optimal Dose Period for Indisetron Tablets for Preventing Chemotherapy-Induced Nausea and Vomiting with Modified FOLFOX6: A Randomized Pilot Study

Chemotherapy ◽  
2012 ◽  
Vol 58 (6) ◽  
pp. 439-444
Author(s):  
Hiroshi Nakatsumi ◽  
Yoshito Komatsu ◽  
Satoshi Yuki ◽  
Susumu Sogabe ◽  
Miki Tateyama ◽  
...  
Keyword(s):  
Pilot Study ◽  
Optimal Dose ◽  
Nausea And Vomiting ◽  
Dose Period ◽  
Modified Folfox6

The optimal dose period of indisetron tablets for preventing chemotherapy-induced nausea and vomiting (CINV) induced by mFOLFOX6: An exploratory trial HGCSG0703.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 589-589
Author(s):  
S. Yuki ◽  
H. Nakatsumi ◽  
M. Tateyama ◽  
Y. Uehata ◽  
M. Kudo ◽  
...  
Keyword(s):  
Single Dose ◽  
Rescue Therapy ◽  
Optimal Dose ◽  
Nausea And Vomiting ◽  
Complete Protection ◽  
Chi Square ◽  
Dose Period ◽  
Chi Square Test ◽  
Group A ◽  
Group B

589 Background: Indisetron is a 5-HT3 receptor antagonist which shows also 5-HT4 antagonistic activity, that had approved in 2004 by Japan's PMDA. There are no recommendations of prophylactic regimens for preventing nausea and vomiting induced by FOLFOX therapy. To explore the optimal dose period of indisetron tablets during mFOLFOX6, we designed the study to compare the antiemetic efficacy and safety of 3-day regimen of indisetron with a single dose regimen. Methods: Advanced colorectal cancer patients who were treated with mFOLFOX6 (+/- bevacizumab) as first-line chemotherapy were enrolled in this study. They were randomly assigned to Group A (3-day of indisetron) or Group B (a single dose of indisetron). Dexamethazone (8mg) was also administered intravenously in both groups before administering of oxaliplatin. The follow-up period was 5 days from the start of chemotherapy. The primary endpoint was complete protection from vomiting, and secondary endpoints were complete protection from nausea, no use of rescue therapy, and severe adverse events. Results: Of 45 patients enrolled in this trial, 42 (93.3%) were assessable. The proportions of patients with complete protection from vomiting were 85.7% in Group A, and 81.0% in Group B (p=1.000; Fisher's exact test). The proportions of patients with complete protection from nausea were 47.6% in each group (p=1.000; chi-square test). The no rescue therapy rates were 66.7% in Group A, and 57.1% in Group B (p=0.525; chi-square test). No severe adverse events were observed in both groups. Conclusions: We suggested that the efficacy of a single dose of indisetron might be equivalent of 3-day regimen for preventing from nausea and vomiting induced by mFOLFOX6. [Table: see text]

AYURVEDIC MANAGEMENT OF GARBHINI CHARDI (Emesis Gravidarum) WITH CHATURJATA CHOORNA (CHATURJATA POWDER) - A PILOT STUDY

2020 ◽  
Vol 8 (9) ◽  
pp. 4317-4323
Author(s):  
Priyanka 1 ◽  
Shreyes. S ◽  
Yogitha Bali M.R
Keyword(s):  
Pilot Study ◽  
Pregnant Women ◽  
First Trimester ◽  
Nausea And Vomiting ◽  
Morning Sickness ◽  
Excessive Salivation ◽  
First Trimester Of Pregnancy ◽  
Rice Water ◽  
Single Blind

Background: During pregnancy many demands are made by growing fetus, to meet these requirements maternal system has to undergo certain changes. Garbhinichardi (Emesis Gravidarum) is one among them and this has been termed as Gruhita Garbha Lakshanas (Immediate signs of conception) in Ayurvedic clas-sics. Approximately 80 % of pregnant women experience excessive salivation, nausea and vomiting during pregnancy, commonly known as “morning sickness”, which is seen frequently throughout the day. Design: This is single blind pilot study. 30 patients with complaints of Garbhinichardi (Emesis Gravidarum) in first trimester were included in this study. Patients were given Chaturjatachurna (Chatutjata powder)for a peri-od of 2 weeks in dose of 3gms thrice a day after meal with Anupana (Adjuvant) as Madhu (honey) of 5ml mixed with Tandulodaka (Raw rice water) Results: This pilot study showed statistically significant changes with Chaturjatachurna in reducing the complaints of pregnant women such as nausea (p<0.001), vomiting (p<0.001) and Aruchi (Anorexia) (p<0.001) in their first trimester of pregnancy. Conclusion: Chaturjata-churna was effective in the management of Garbhini Chardi (Emesis Gravidarum) and other symptoms in the first trimester of pregnancy.

Effect of remifentanil on postoperative nausea and vomiting: a randomized pilot study

2018 ◽  
Vol 32 (5) ◽  
pp. 781-785 ◽  
Author(s):  
Tatsunori Watanabe ◽  
Koji Moriya ◽  
Naoto Tsubokawa ◽  
Hiroshi Baba
Keyword(s):  
Pilot Study ◽  
Postoperative Nausea ◽  
Postoperative Nausea And Vomiting ◽  
Nausea And Vomiting

scholarly journals Management of radiation-induced nausea and vomiting with palonosetron in patients with pre-existing emesis: a pilot study

2018 ◽  
Vol 7 (4) ◽  
pp. 385-392 ◽  
Author(s):  
Vithusha Ganesh ◽  
Stephanie Chan ◽  
Liying Zhang ◽  
Leah Drost ◽  
Carlo DeAngelis ◽  
...  
Keyword(s):  
Pilot Study ◽  
Nausea And Vomiting ◽  
Radiation Induced

Treatment of metastatic renal cell carcinoma with coumarin (1,2-benzopyrone) and cimetidine: a pilot study.

1987 ◽  
Vol 5 (6) ◽  
pp. 862-866 ◽  
Author(s):  
M E Marshall ◽  
L Mendelsohn ◽  
K Butler ◽  
L Riley ◽  
J Cantrell ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Pilot Study ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Renal Carcinoma ◽  
Optimal Dose ◽  
Measurable Disease ◽  
Duration Of Response ◽  
Progression Of Disease

Forty-five patients with metastatic renal cell carcinoma were treated with coumarin (1,2-benzopyrone) and cimetidine. Patients received coumarin, 100 mg orally daily; cimetidine administration, 300 mg orally four times daily, was initiated on day 15 of therapy, and treatment with both drugs was continued until progression of disease. Three patients are too early to evaluate (on study less than or equal to 2 months with no change in tumor status). Objective responses (greater than or equal to 50% reduction in measurable disease) occurred in 14 of 42 evaluable patients (33.3%) (the 95% confidence interval based on this rate is +/- 14.3%), with three complete responses and 11 partial responses (PR). Complete responses lasted 9.5, 4+, and 9.5+ months. The median duration of response for the PR group was 5 months (range, 4 to 21+ months). Twelve patients experienced stabilization of disease ranging from 4 to 16.5+ months. No response was seen in 16 patients. There was no symptomatic, hematologic, or chemical (organ dysfunction) toxicity among the 45 patients treated. Coumarin and cimetidine appear to be safe and active agents in the treatment of metastatic renal carcinoma. Further studies are required to determine the optimal dose and scheduling of these agents.

Granisetron: The Second Serotonin-Receptor Antagonist

1995 ◽  
Vol 29 (12) ◽  
pp. 1240-1251 ◽  
Author(s):  
Val R Adams ◽  
Amy W Valley
Keyword(s):  
Clinical Trials ◽  
Adverse Effects ◽  
Receptor Antagonist ◽  
Serotonin Receptor ◽  
English Language ◽  
Data Extraction ◽  
Optimal Dose ◽  
Nausea And Vomiting ◽  
Cost Comparison ◽  
Antiemetic Agents

Objective: To review the pharmacology, pharmacokinetics, clinical efficacy, and adverse effects of granisetron, focusing on critical analysis of published clinical trials and comparison with other antiemetic agents, including ondansetron. Data Sources: MEDLINE (1966–1995) and CANCERLIT (1991–1995) searches of English-language literature using the terms “granisetron” and “granisetron (m)” were performed. Study Selection And Data Extraction: All articles were considered for possible inclusion in this review. Abstracts of clinical trials were included only when they were judged to add critical information not otherwise available in the medical literature. For studies published more than once, the most recent publication was cited. Data Synthesis: Nausea and vomiting are rated by patients as the most distressing chemotherapy-related adverse effects and may produce potentially life-threatening complications. The discovery of the role of serotonin in nausea and vomiting and the development of selective serotonin3-receptor (5-HT3) antagonists has significantly diminished the incidence and consequences of chemotherapy-related nausea and vomiting. Granisetron is the second 5-HT3-receptor antagonist to be marketed in the US. Granisetron has been compared with other antiemetic agents, including ondansetron, against highly and moderately emetogenic chemotherapy. The results of these trials have shown granisetron to be superior to conventional antiemetics and as effective as ondansetron in the prevention of chemotherapy-induced nausea and vomiting. The optimal dose of granisetron has yet to be determined. Formulary decisions should be based on a cost comparison among the 5-HT3-receptor antagonists at individual institutions. Conclusions: Granisetron is a safe, effective antiemetic agent for the management of nausea and vomiting caused by cancer chemotherapy.

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