Protection against chemotherapy induced damage in the digestive tract in childhood cancer patients
| ISRCTN | ISRCTN13358395 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13358395 |
| Secondary identifying numbers | NTR401 |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 04/11/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Rob Pieters
Scientific
Scientific
Erasmus Medical Centre
Sophia Children's Hospital
Department of Oncology/Haematology
P.O. Box 2060
Rotterdam
3015 GJ
Netherlands
| Phone | +31 (0)10 4636691 |
|---|---|
| rob.pieters@erasmusmc.nl |
Study information
| Study design | Randomised, double-blind placebo controlled crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Scientific title | |
| Study objectives | 1. Transforming growth factor beta (TGF-beta) protects childhood cancer patients against chemotherapy induced damage in the digestive tract 2. TGF-beta can safely be administered to childhood cancer patients |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Chemotherapy induced damage in the digestive tract |
| Intervention | Nutritional supplement TGF-beta is added to (tube) feeding and compared to placebo during two similar courses of chemotherapy in a randomised, double-blind crossover design. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Transforming growth factor beta (TGF-beta) |
| Primary outcome measure | Gastrointestinal toxicity such as: 1. Mucositis 2. Diarrhoea 3. Intestinal permeability Safety: 1. Renal function 2. Serum TGF-beta |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/01/2001 |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 0 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | 1. Children with acute non-lymphocytic leukaemia (ANLL), myelodysplastic syndromes (MDS), B-cell non-hodgkin's lymphoma (B-NHL), infant acute lymphoblastic leukaemia (ALL) who will receive two or more similar courses of chemotherapy 2. Children diagnosed with other malignancies who receive more than two similar courses of chemotherapy and develop mucosal barrier injury during one of the first courses 3. Aged 0 - 18 years 4. Informed consent |
| Key exclusion criteria | 1. Clinical signs of inflammatory bowel disease, coeliac disease or cow's milk protein allergy 2. Radiotherapy of the abdomen less than 6 months before TGF-beta administration |
| Date of first enrolment | 01/01/2001 |
| Date of final enrolment | 31/12/2004 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Centre
Rotterdam
3015 GJ
Netherlands
3015 GJ
Netherlands
Sponsor information
Danone Research B.V. (The Netherlands)
Industry
Industry
P.O. Box 7005
Wageningen
6700 CA
Netherlands
"ROR" |
https://ror.org/01c5aqt35 |
|---|
Funders
Funder type
Not defined
Not provided at time of registration
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
