Protection against chemotherapy induced damage in the digestive tract in childhood cancer patients.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23956

Enrollment

Registered

2005-09-13

Start date

2001-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

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.

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Gastro-intestinal toxicity such as: 1. Mucositis; 2. Diarrhoea; 3. Intestinal permeability; Safety: 4. Renal function; 5. Serum TGF-beta2.	—

Contacts

Public ContactRob Pieters

Erasmus Medical Center, Sophia Children's Hospital, Department of Oncology/Hematology, P.O. Box 2060

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

Outcome results