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)
- Conditions
- Colorectal Cancer
- Registration Number
- JPRN-UMIN000013249
- Lead Sponsor
- HOPE group(Hokkaido Supportive Care Oncology Project - an Expert Group Initiative)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 320
Not provided
1)Serious or uncontrolled complication 2)Symptomatic or clinically suspected brain metastasis 3)Convulsive disorder requiring anti-convulsant 4)Ascites fluid or pleural effusion requiring paracentesis 5)Gastrointestinal obstruction 6)Vomiting and/or grade 1 or more nausea at baseline 7)Patients with planned radiotherapy 8)History of hypersensitivity to 5-HT3 receptor antagonist 9)History of hypersensitivity to dexamethasone 10) Continuous administration of steroids 11) Poorly controlled nausea by opioids 12)Pregnancy, lactation or who does not wish to contraception 13)History of palonosetorn administration 14)Without capability or intention of cooperating with study procedure 15)Participant in other anti-emetic trial 16)Undesirable for the patient to enter the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete response rate (overall period)
- Secondary Outcome Measures
Name Time Method Complete response rate (acute, delayed phase) Complete control rate (overall period, acute, delayed phase) Total control rate (overall period, acute, delayed phase) No rescue medication rate Antiemetic agents-related adverse events Influence of steroids long-term use *Change of antiemetic agents *Transition of HbA1c *Adverse events (allergic reaction, nausea, vomiting, anorexia)