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A randomized, multicenter non-inferiority trial of 1-day versus 3-day dexamethasone in combination with palonosetron for prevention of nausea and vomiting induced by moderately emetogenic chemotherapy

ABSTRACT: Interventions: dexamethasone day1-3 plus palonosetron dexamethasone day1 plus palonosetron Primary outcome(s): Percentage of patients with complete response (no vomiting and no rescue medication) during day1-5 after moderately emetogenic chemotherapy Study Design: Parallel Randomized

DISEASE(S): Colorectal Cancer, Lung Cancer, Breast Cancer

PROVIDER: 2624800 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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The efficacy of combination antiemetic therapy with Olanzapine, Palonosetron and dexamethasone for the prevention of nausea and vomiting in patients receiving Moderately Emetogenic Chemotherapy

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Randomized Phase II trial of Palonosetron/Dexamethasone concurrent therapy with prevention of CINV according to chemotherapy including Oxaliplatin or Irinotecan in patients with advanced colorectal cancer.

Project description:Interventions: Group A(Normal Group of Dexamethasone) Day1 Dexamethasone 9.9mg/body (i.v) Palonosetron 0.75mg/body Day2-3 Dexamethasone 8mg/body (p.o) This administration method repeated 4 courses. Group B(Loss Group of Dexamethasone) Day1 Dexamethasone 9.9mg/body (i.v) Palonosetron 0.75mg/body Day2-3 Dexamethasone 2mg/body (p.o) This administration method repeated 4 courses. Primary outcome(s): Delayed(24-120hr) complete response rate Study Design: Parallel Randomized

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A randomized phase III trial of palonosetron versus palonosetron plus dexamethasone (day1) for the prevention of nausea and vomiting induced by moderately emetogenic chemotherapy (HOPE-02)

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Phase II Trial of Aprepitant & Palonosetron for CINV Prevention w FOLFOX

Project description:RATIONALE: Aprepitant, palonosetron, and dexamethasone may help lessen or prevent nausea and vomiting in patients receiving chemotherapy. PURPOSE: This phase II trial is studying how well giving aprepitant together with palonosetron and dexamethasone works in preventing nausea and vomiting caused by chemotherapy in patients receiving chemotherapy for metastatic colorectal cancer.

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Efficacy of preventive treatment of nausea and vomiting induced by chemotherapy of Colorectal Cancer

Project description:Interventions: Palonosetron/Dexamethasone Palonosetron/Dexamethasone plus aprepitant Primary outcome(s): Complete Response Rate Study Design: Parallel Randomized

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Examination about the pharmacokinetics of the dexamethasone under the Fosaprepitant medication to the nausea and vomiting of an high emetic risk chemotherapy.

Project description:Interventions: Group A: * 1st course: Palonosetron 0.75mg i.v. on 1st day+Aprepitant 150mg i.v. on 1st day+Dexamethasone 9.9mg i.v. on 1st day, 6.6mg i.v. on 2nd day and 3rd day. * 2nd course: Palonosetron 0.75mg i.v. on 1st day+Aprepitant 150mg i.v. on 1st day+Dexamethasone 9.9mg i.v. on 1st day, 6.6mg i.v. on 2nd day and 13.2mg i.v. on 3rd day. Group B: * 1st course: Palonosetron 0.75mg i.v. on 1st day+Aprepitant 150mg i.v. on 1st day+Dexamethasone 9.9mg i.v. on 1st day, 6.6mg i.v. on 2nd day and 13.2mg i.v. on 3rd day. * 2nd course: Palonosetron 0.75mg i.v. on 1st day+Aprepitant 150mg i.v. on 1st day+Dexamethasone 9.9mg i.v. on 1st day, 6.6mg i.v. on 2nd day and 3rd day. Primary outcome(s): * Blood concentration of dexamethasone Study Design: Cross-over Randomized

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Study protocol for SPARED trial: randomised non-inferiority phase III trial comparing dexamethasone on day 1 with dexamethasone on days 1-4, combined with neurokinin-1 receptor antagonist, palonosetron and olanzapine (5 mg) in patients receiving cisplatin-based chemotherapy.

Project description:IntroductionDexamethasone (DEX) is administered for multiple days to prevent chemotherapy-induced nausea and vomiting for patients receiving highly emetogenic chemotherapy (HEC); however, its notorious side effects have been widely reported. Although our multicentre randomised double-blind comparative study verified non-inferiority of sparing DEX after day 2 of chemotherapy when combined with neurokinin-1 receptor antagonist (NK1-RA) and palonosetron (Palo) for patients receiving HEC regimen, DEX sparing was not non-inferior in patients receiving cisplatin (CDDP)-based HEC regimens in subgroup analysis. Recently, the efficacy of the addition of olanzapine (OLZ) to standard triple antiemetic therapy on HEC has been demonstrated by several phase III trials. This study aims to confirm non-inferiority of DEX sparing when it is combined with NK-1RA, Palo and OLZ in patients receiving CDDP-based HEC regimens.Methods and analysisThis is a randomised, double-blind, phase III trial. Patients who are scheduled to receive CDDP ≥50 mg/m2 as initial chemotherapy are eligible. Patients are randomly assigned to receive either DEX on days 1-4 or DEX on day 1 combined with NK1-RA, Palo and OLZ (5 mg). The primary endpoint is complete response (CR) rate, defined as no emesis and no rescue medications during the delayed phase (24-120 hours post-CDDP administration). The non-inferiority margin is set at -15.0%. We assume that CR rates would be 75% in both arms. Two hundred and sixty-two patients are required for at least 80% power to confirm non-inferiority at a one-sided significance level of 2.5%. After considering the possibility of attrition, we set our final required sample size of 280.Ethics and disseminationThe institutional review board approved the study protocol at each of the participating centres. The trial result will be presented at international conferences and published in peer-reviewed journals.Trial registration numberUMIN000032269.

| S-EPMC7747608 | biostudies-literature

Effects of dexamethasone on gene expression in rat pancreatic AR42J cell line

Project description:The rat pancreatic cell line AR42J is relatively undifferentiated under normal culture conditions. When the glucocorticoid dexamethasone is added to the medium the cells display a dramatic decrease in proliferative rate and are induced to a more exocrine phenotype that includes increased expression of exocrine pancreas products (digestive enzymes) and more developed regulated secretion. We used microarray to determine changes in gene expression comparing control (without dexamethasone) vs induced (plus dexamethasone).

2015-09-11 | GSE72907 | GEO

Efficacy and safety of palonosetron and dexamethasone in patients who haven’t responded to conventional antiemetic agents; granisetron and dexamethasone

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A validation study of preventing oxaliplatin-induced hypersensitivity reactions by dexamethasone. (AVOID)

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