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

Erasmus Medical Centre
Sophia Children's Hospital
Department of Oncology/Haematology
P.O. Box 2060
Rotterdam
3015 GJ
Netherlands

Phone +31 (0)10 4636691
Email rob.pieters@erasmusmc.nl

Study information

Study designRandomised, double-blind placebo controlled crossover trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Scientific title
Study objectives1. 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) studiedChemotherapy induced damage in the digestive tract
InterventionNutritional 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Transforming growth factor beta (TGF-beta)
Primary outcome measureGastrointestinal toxicity such as:
1. Mucositis
2. Diarrhoea
3. Intestinal permeability

Safety:
1. Renal function
2. Serum TGF-beta
Secondary outcome measuresNo secondary outcome measures
Overall study start date01/01/2001
Completion date31/12/2004

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit0 Years
Upper age limit18 Years
SexBoth
Target number of participants30
Key inclusion criteria1. 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 criteria1. 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 enrolment01/01/2001
Date of final enrolment31/12/2004

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Erasmus Medical Centre
Rotterdam
3015 GJ
Netherlands

Sponsor information

Danone Research B.V. (The Netherlands)
Industry

P.O. Box 7005
Wageningen
6700 CA
Netherlands

ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan