A phase IV monocentre study to evaluate palonosetron in nausea/vomiting prevention in patients with breast or colon cancer, treated with moderately aemotogenic chemotherapic agents - ND
- Conditions
- nausea and vomiting preventionMedDRA version: 9.1Level: LLTClassification code 10054133Term: Prophylaxis of nausea and vomiting
- Registration Number
- EUCTR2007-004853-27-IT
- Lead Sponsor
- OSPEDALE POLICLINICO S. MATTEO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
male or female, age >/= 18, with colonrectal cancer or breast cancer, candidate to chemotherapy Folfox 4 or Folfiri or AC, AC-T, FEC o FAC, chemotherapy-naive, ...
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
prior treatment with chemotherapy or palonosetron,use of sperimental drug during 30 days before screening, nausea or vomiting during screening, intestinal obstruction, ...
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to evaluate palonosetron in nausea/vomiting prevention in patients with breast or colon cancer, treated with moderately aemotogenic chemotherapic agents;Secondary Objective: Not specified;Primary end point(s): % of patients with complete response (no aemetic episodes and no rescue therapy) during the study
- Secondary Outcome Measures
Name Time Method