Contact information
Type
Scientific
Primary contact
Prof Rob Pieters
ORCID ID
Contact details
Erasmus Medical Centre
Sophia Children's Hospital
Department of Oncology/Haematology
P.O. Box 2060
Rotterdam
3015 GJ
Netherlands
+31 (0)10 4636691
rob.pieters@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR401
Study information
Scientific title
Acronym
Study hypothesis
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
Received from the local medical ethics committee
Study design
Randomised, double-blind placebo controlled crossover trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Transforming growth factor beta (TGF-beta)
Primary outcome measures
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 trial start date
01/01/2001
Overall trial end date
31/12/2004
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
30
Participant 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
Recruitment start date
01/01/2001
Recruitment end date
31/12/2004
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Centre
Rotterdam
3015 GJ
Netherlands
Funders
Funder type
Not defined
Funder name
Not provided at time of registration
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary