Exploratory study for prevention of nausea and vomiting switching from Granisetron + Dexamethasone (Day1-3) + Aprepitant (Day1-3) to Palonosetron + Dexamethasone (Day1) in patients given moderately emetogenic chemotherapy

Phase 2

Recruiting

• Conditions: colorectal cancer

• Registration Number: JPRN-UMIN000021593
• Lead Sponsor: Iwate Medical University, School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-24
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

1) Serious or uncontrolled complication (e.g. ileus or pulmonary fibrosis, diabetes, heart failure, myocardial infarction, angina, kidney failure, liver failure, mental disorder, cerebrovascular disease, active gastroduodenal ulcer) 2) Symptomatic or clinically suspected brain metastasis 3) Convulsive disorder needs anticonvulsants 4) Ascites fluid or pleural effusion needs paracentesis 5) Pyloristenosis or intestinal obstruction 6) Evident anticipatory nausea and vomiting 7) Hypersensitivity for components of 5-HT3 receptor antagonist, NK1 receptor antagonist, dexamethasone 8) Pregnancy, lactation or who does not wish to contraception 9) Capability or intention of cooperating 10) Undesirable for the patient to enter the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ausea (Overall study period)

Secondary Outcome Measures

Name	Time	Method
ausea (acute phase, delayed phase) Complete Response (Overall study period, acute phase, delayed phase) Complete Protection (Overall study period, acute phase, delayed phase) Total Control (Overall study period, acute phase, delayed phase) Evaluation method about nausea Safety Adverse event related to DEX