Protection against chemotherapy induced damage in the digestive tract in childhood cancer patients.
Completed
- Registration Number
- NL-OMON23956
- Lead Sponsor
- umico Research
- Brief Summary
1. Pediatr Blood Cancer. 2007 May;48(5):532-9.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
1. Children with ANLL, MDS, B-NHL, infant ALL who will receive 2 or more similar courses of chemotherapy;
2. Children diagnosed with other malignancies who receive more than 2 similar courses of chemotherpy and develop mucosal barrier injury during one of the first courses;
Exclusion Criteria
1. Clinical signs of inflammatory bowel disease, coeliac disease or cow's milk protein allergy;
2. Radiotheray of the abdomen less than 6 months before TGF-beta2 administration.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Gastro-intestinal toxicity such as:<br /><br>1. Mucositis;<br /><br>2. Diarrhoea; <br /><br>3. Intestinal permeability;<br /><br><br /><br /><br>Safety:<br /><br>4. Renal function;<br /><br>5. Serum TGF-beta2.
- Secondary Outcome Measures
Name Time Method