|- candidate number||1647|
|- NTR Number||NTR401|
|- Date ISRCTN created||27-jan-2006|
|- date ISRCTN requested||18-nov-2005|
|- Date Registered NTR||13-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||Protection against chemotherapy induced damage in the digestive tract in childhood cancer patients.|
|- Scientific Title||Protection against chemotherapy induced damage in the digestive tract in childhood cancer patients.|
|- hypothesis||1. TGF-beta protects childhood cancer patients against chemotherapoy induced damage in the digestive tract;|
2. TGF-beta can safely be administered to childhood cancer patients.
|- Healt Condition(s) or Problem(s) studied||Carcinoma, Cancer, Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia , Non Hodkin's lymfoma (NHL), Myelodysplastic syndrome (MDS)|
|- 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;
3. Age 0-18 years;
4. Informed consent.
|- 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.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2001|
|- planned closingdate||31-dec-2004|
|- Target number of participants||30|
|- Interventions||Nutritional supplement TGF-beta2 is added to (tube) feeding and compared to placebo during two similar courses of chemotherapy in a randomised, double-blind crossover design.|
|- Primary outcome||Gastro-intestinal toxicity such as:|
3. Intestinal permeability;
4. Renal function;
5. Serum TGF-beta2.
|- Secondary outcome||N/A|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. Rob Pieters|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. Rob Pieters|
|- Sponsor/Initiator ||Danone Research B.V.|
(Source(s) of Monetary or Material Support)
|- Publications||1. Pediatr Blood Cancer. 2007 May;48(5):532-9.|
|- Brief summary||Patients receive investigation product during one course of chemotherapy and control placebo during the other similar course. Order of administration is determined by randomisation. |
During and after the chemotherapy course different parameters of gastro-intestinal toxicity and safety are determined.
|- Main changes (audit trail)|
|- RECORD||13-sep-2005 - 23-jun-2008|