Effect of Bovine Colostrum on Toxicity and Inflammatory Responses (CALL)

Steffen Husby

Status: Completed

Conditions: Acute Lymphoblastic Leukemia

Treatments: Dietary Supplement: placebo; Dietary Supplement: Bovine Colostrum

Study type: Interventional

Funder types: Other

Identifiers

NCT01766804

OUH-HCA-002

Details and patient eligibility

About

The aim of the present study is to evaluate the ability a colostrum containing diet to limit gastrointestinal toxicity including chemotherapy induced inflammation in children treated for acute lymphoblastic leukemia.

Full description

Acute lymphoblastic leukaemia (ALL) is the most common form of childhood cancers. Cure rates are improving, but the intensity of treatment is limited by toxicity. 2-5% of patients die of treatment related complications, mostly related to therapy-induced toxicity and immune suppression. The aim of the present study is to evaluate the ability a colostrum containing diet to limit gastrointestinal toxicity including chemotherapy induced inflammation. The study is based on patients treated according to the current NOPHO protocol.

Enrollment: 62 patients

Sex: All

Ages: 1 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients treated according to the Nordic Society of Pediatric Haematology and Oncology (NOPHO) ALL protocol

Exclusion criteria

• Milk Allergy
• Lactose intolerance

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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62 participants in 2 patient groups, including a placebo group

Bovine colostrum

Experimental group

Description:

A daily supplement of bovine colostrum powder.

Treatment:

Dietary Supplement: Bovine Colostrum

Placebo

Placebo Comparator group

Description:

A daily placebo supplement consisting of whole milk powder and whey protein.

Treatment:

Dietary Supplement: placebo