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.
ID
Bron
Verkorte titel
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Gastro-intestinal toxicity such as:<br>
1. Mucositis;<br>
2. Diarrhoea; <br>
3. Intestinal permeability;<br>
<br><br>
Safety:<br>
4. Renal function;<br>
5. Serum TGF-beta2.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
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.
Publiek
P.O. Box 2060
Rob Pieters
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636691
rob.pieters@erasmusmc.nl
Wetenschappelijk
P.O. Box 2060
Rob Pieters
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636691
rob.pieters@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL362 |
| NTR-old | NTR401 |
| Ander register | : N/A |
| ISRCTN | ISRCTN13358395 |