No registrations found.
ID
Source
Brief title
Sponsors and support
Intervention
Outcome measures
Primary outcome
Gastro-intestinal toxicity such as:
1. Mucositis;
2. Diarrhoea;
3. Intestinal permeability;
Safety:
4. Renal function;
5. Serum TGF-beta2.
Secondary outcome
N/A
Background 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.
Study objective
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.
Study design
N/A
Intervention
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.
P.O. Box 2060
Rob Pieters
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636691
rob.pieters@erasmusmc.nl
P.O. Box 2060
Rob Pieters
Dr. Molewaterplein 60
Rotterdam 3015 GJ
The Netherlands
+31 (0)10 4636691
rob.pieters@erasmusmc.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL362 |
| NTR-old | NTR401 |
| Other | : N/A |
| ISRCTN | ISRCTN13358395 |