Randomized pilot study of optimal dose period for indisetron tablets for preventing chemotherapy-induced nausea and vomiting with mFOLFOX6: HGCSG0703
Ontology highlight
ABSTRACT:
DISEASE(S): Colorectal Cancer
PROVIDER: 2632889 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:Interventions: indisetrone
garnisetrone
Primary outcome(s): Incidence of acute-onset diarrhea Complete protection from vomiting
Study Design: Parallel Randomized
| 2625553 | ecrin-mdr-crc
Project description:Addition of aprepitant, an NK1 receptor antagonist to a 5-HT3 receptor antagonist and dexamethasone regimen was shown to be effective for prevention of chemotherapy-induced nausea and vomiting (CINV) with moderately emetogenic chemotherapy (MEC). Little is known about the efficacy of aprepitant when used without dexamethasone. Dexamethasone is widely used to prevent both acute and delayed nausea and vomiting induced by chemotherapy. However, multi-period use of dexamethasone could be associated with side effect, such as hyperglycemia, dyspepsia and insomnia. This randomized phase III trial studies antiemetic therapy with aprepitant and tropisetron to see how well they work compared to dexamethasone plus tropisetron in preventing chemotherapy-induced nausea and vomiting in patients with colorectal cancer receiving FOLFOX(oxaliplatin, leuvovorin and 5-fluorouracil) chemotherapy.
| 2225674 | ecrin-mdr-crc
Project description:BACKGROUND:Postoperative nausea and vomiting (PONV) are common complications following surgery and anaesthesia. Drugs to prevent PONV are only partially effective. An alternative approach is to stimulate the P6 acupoint on the wrist. This is an update of a Cochrane review first published in 2004. OBJECTIVES:To determine the efficacy and safety of P6 acupoint stimulation in preventing PONV. SEARCH STRATEGY:We searched CENTRAL (The Cochrane Library, Issue 3, 2008), MEDLINE (January 1966 to September 2008), EMBASE (January 1988 to September 2008), ISI Web of Science (January 1965 to September 2008), the National Library of Medicine publication list of acupuncture studies, and reference lists of articles. SELECTION CRITERIA:All randomized trials of techniques that stimulated the P6 acupoint compared with sham treatment or drug therapy for the prevention of PONV. Interventions used in these trials included acupuncture, electro-acupuncture, transcutaneous nerve stimulation, laser stimulation, capsicum plaster, an acu-stimulation device, and acupressure in patients undergoing surgery. Primary outcomes were the risks of nausea and vomiting. Secondary outcomes were the need for rescue antiemetic therapy and adverse effects. DATA COLLECTION AND ANALYSIS:Two review authors independently assessed trial quality and extracted the data. We collected adverse effect information from the trials. We used a random-effects model and reported relative risk (RR) with associated 95% confidence intervals (95% CI). MAIN RESULTS:We included 40 trials involving 4858 participants; four trials reported adequate allocation concealment. Twelve trials did not report all outcomes. Compared with sham treatment P6 acupoint stimulation significantly reduced: nausea (RR 0.71, 95% CI 0.61 to 0.83); vomiting (RR 0.70, 95% CI 0.59 to 0.83), and the need for rescue antiemetics (RR 0.69, 95% CI 0.57 to 0.83). Heterogeneity among trials was moderate. There was no clear difference in the effectiveness of P6 acupoint stimulation for adults and children; or for invasive and noninvasive acupoint stimulation. There was no evidence of difference between P6 acupoint stimulation and antiemetic drugs in the risk of nausea (RR 0.82, 95% CI 0.60 to 1.13), vomiting (RR 1.01, 95% CI 0.77 to 1.31), or the need for rescue antiemetics (RR 0.82, 95% CI 0.59 to 1.13). The side effects associated with P6 acupoint stimulation were minor. There was no evidence of publication bias from contour-enhanced funnel plots. AUTHORS' CONCLUSIONS:P6 acupoint stimulation prevented PONV. There was no reliable evidence for differences in risks of postoperative nausea or vomiting after P6 acupoint stimulation compared to antiemetic drugs.
| S-EPMC3113464 | biostudies-literature
Project description:Intervention 1: In the intervention group: gabapentin capsule of 300 milligrams three times a day from one day Chemotherapy will be used until the end of the chemotherapy period. Intervention 2: In the control group, for the reduction of nausea and vomiting after chemotherapy, a routine of three drugs (dexamethasone, ranitidine and ketril) will be used.;Treatment - Drugs;Treatment - Drugs;In the intervention group: gabapentin capsule of 300 milligrams three times a day from one day Chemotherapy will be used until the end of the chemotherapy period.;In the control group, for the reduction of nausea and vomiting after chemotherapy, a routine of three drugs (dexamethasone, ranitidine and ketril) will be used
Primary outcome(s): Nausea and vomiting. Timepoint: after intervention. Method of measurement: By grade.
Study Design: Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.
| 2493651 | ecrin-mdr-crc
Project description: Not available
| S-EPMC4204618 | biostudies-literature
Project description:RATIONALE: Palonosetron hydrochloride may prevent nausea and vomiting caused by radiation therapy. It is not yet known whether palonosetron hydrochloride is more effective than a placebo in preventing nausea and vomiting.
PURPOSE: This randomized phase II trial is studying the side effects of palonosetron hydrochloride and to see how well it works in preventing nausea and vomiting caused by radiation therapy in patients with primary abdominal cancer.
| 2072434 | ecrin-mdr-crc
Project description:Specific phobia of vomiting (SPOV) is a clinical condition with early onset, chronic course and substantial psychosocial impairment due to a rigorous avoidance behavior. A primary symptom which drives patients to consult a medical practitioner is nausea. In this study our aim was to further analyze this symptom of SPOV and examined its role in the development and manifestation of the phobia. We conducted an internet survey in the german SPOV-internet-forum. We calculated a nausea score and grouped participants in a high-and low-nausea group to examine the relationship between nausea and characteristics of the fear of vomiting. In this sample (N = 131), nausea was fairly common in most participants with fear of vomiting. Participants in the high-nausea group had significantly higher ratings of subjective fear and significantly longer duration of fear of vomiting. Additionally, the high-nausea group contained more participants with a body mass index below 19 than the low-nausea group. The present findings suggest that nausea is a core symptom in SPOV which is closely related to intensity of the fear, duration of the fear, and body weight. Future research should investigate if nausea-specific design of treatment could improve therapy outcome.
| S-EPMC4217587 | biostudies-literature
Project description:Previous randomized controlled trials have reported conflicting findings on the superiority of palonosetron over ramosetron for preventing postoperative nausea and vomiting (PONV). Therefore, the present systematic review was registered in PROSPERO (CRD42016038120) and performed to compare the efficacy of perioperative administration of palonosetron to that of ramosetron for preventing PONV. We searched MEDLINE, EMBASE, and CENTRAL to identify all randomized controlled trials that compared the effectiveness of perioperative administration of palonosetron to that of ramosetron. The primary endpoints were defined as the incidence of postoperative nausea (PON), postoperative vomiting (POV), and PONV. A total of 695 patients were included in the final analysis. Subgroup analysis was performed through administration times which were divided into two phases: the early phase of surgery and the end of surgery. Combined analysis did not show differences between palonosetron and ramosetron in the overall incidence of PON, POV or PONV. Palonosetron was more effective than ramosetron, when the administration time for the 5-HT3 receptor antagonist was during the early phase of the operation. Otherwise, ramosetron was more effective than palonosetron, when the administration time was at the end of surgery. However, the quality of evidence for each outcome was low or very low and number of included studies was small, limiting our confidence in findings.
| S-EPMC5167547 | biostudies-literature
Project description:BACKGROUND:Intravenous lidocaine in adults undergoing general anesthesia has been shown to reduce the incidence of postoperative nausea and vomiting (PONV). However, the anti-postoperative vomiting (POV) effect of lidocaine in pediatric patients remains unclear. We conducted a systematic review and meta-analysis with Trial Sequential Analysis to evaluate the effect of intravenous lidocaine on prevention of POV/PONV. METHODS:Six databases including trial registration sites were searched. Randomized clinical trials evaluating the incidence of POV/PONV after intravenous lidocaine compared with control were included. The primary outcome was the incidence of POV within 24 hours after general anesthesia. The incidence of POV was combined as a risk ratio with 95% confidence interval using a random-effect model. We used the I2 to assess heterogeneity. We evaluated the quality of trials using the Cochrane methodology, and we assessed quality of evidence using the Grading of Recommendation Assessment, Development, and Evaluation approach. We also assessed adverse events. RESULTS AND DISCUSSION:Six trials with 849 patients were included, of whom 433 received intravenous lidocaine. Three trials evaluated the incidence of POV, and 3 evaluated the incidence of PONV. The overall incidence of POV within 24 hours after anesthesia was 45.9% in the lidocaine group and 63.4% in the control group (risk ratio, 0.73; 95% confidence interval, 0.53-1.00; I2 = 32%; p = 0.05). The incidence of PONV within 24 hours after anesthesia was 3.73% in the lidocaine group and 4.87% in the control group (RR, 0.76; 95% CI, 0.36-1.59; I2 = 0%; p = 0.47). The quality of evidence was downgraded to "very low" due to the study designs, inconsistency, imprecision, and possible publication bias. CONCLUSION:Our meta-analysis suggests that intravenous lidocaine infusion may reduce the incidence of POV, however, the evidence quality was "very low." Further trials with a low risk of bias are necessary.
| S-EPMC6986726 | biostudies-literature
Project description:RATIONALE: Learning how often patients experience nausea and vomiting after receiving anti-vomiting medicine and chemotherapy for colorectal cancer may help doctors plan better treatment and improve patients’ quality of life.
PURPOSE: This clinical trial is studying delayed nausea and vomiting in patients with colorectal cancer receiving standard anti-vomiting medicine during the first course of chemotherapy.
| 2059306 | ecrin-mdr-crc