Condition category
Digestive System
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
04/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Danone Research B.V. (The Netherlands)

Sponsor details

P.O. Box 7005
Wageningen
6700 CA
Netherlands

Sponsor type

Industry

Website

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

Publication citations

Additional files

Editorial Notes