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van CCT (UK)


Protection against chemotherapy induced damage in the digestive tract in childhood cancer patients.


- candidate number1647
- NTR NumberNTR401
- ISRCTNISRCTN13358395
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR13-sep-2005
- Secondary IDsN/A 
- Public TitleProtection against chemotherapy induced damage in the digestive tract in childhood cancer patients.
- Scientific TitleProtection against chemotherapy induced damage in the digestive tract in childhood cancer patients.
- ACRONYMN/A
- hypothesis1. 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) studiedCarcinoma, Cancer, Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia , Non Hodkin's lymfoma (NHL), Myelodysplastic syndrome (MDS)
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2001
- planned closingdate31-dec-2004
- Target number of participants30
- InterventionsNutritional 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 outcomeGastro-intestinal toxicity such as:
1. Mucositis;
2. Diarrhoea;
3. Intestinal permeability;


Safety:
4. Renal function;
5. Serum TGF-beta2.
- Secondary outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESProf. Dr. Rob Pieters
- CONTACT for SCIENTIFIC QUERIESProf. Dr. Rob Pieters
- Sponsor/Initiator Danone Research B.V.
- Funding
(Source(s) of Monetary or Material Support)
[default]
- Publications1. Pediatr Blood Cancer. 2007 May;48(5):532-9.
- Brief summaryPatients 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)
- RECORD13-sep-2005 - 23-jun-2008


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