Sandostatin LAR in prevention of Chemotherapy Induced Diarrhea
- Conditions
- Chemo-Therapy Induced Diarrhea
- Registration Number
- EUCTR2006-001150-27-BE
- Lead Sponsor
- niversity Hospital Gent
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
• Patient should be Sandostatin® or SSA naïve for at least 3 months prior to study entry (in the therapeutic phase). However, Sandostatin® s.c. is allowed after administration of the full dose chemotherapy as rescue medication. Once the first Sandostatin® LAR® is administered in the protocol, Sandostatin®s.c. is no longer needed.
• Patient with histologically proven malignancy treated with chemotherapy and experiencing a more than or equal to grade II diarrhea
• All chemotherapeutic regimens administered two or three weekly with or without biotherapies are allowed. (Examples of regimens chemotherapy associated with a = 40 % grade II diarrhea are provided in Appendix 1).
• Prior chemotherapy is allowed, even with diarrhoea
• Older than 18 years
• Written informed consent given
• Performance status ECOG less or equal than 2
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
• Patient with infectious diarrhea or severe irritable bowel or inflammatory bowel disease
• HIV positive patients
• Biotherapies alone
• Patient with known allergic reaction or hypersensitivity to Sandostatin® or SSA analogues
• Symptomatic cholecystolithiasis
• Uncontrolled diabetes
• Female patients who are lactating or child bearing potential without adequate contraceptive measures
• Patients who were included in another study protocol less than 30 days before entering this protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method