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Effect of Bovine Colostrum on Toxicity and Inflammatory Responses During Treatment of Childhood Acute Lymphoblastic Leukaemia


N/A
1 Year
45 Years
Open (Enrolling)
Both
Acute Lymphoblastic Leukemia

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Trial Information

Effect of Bovine Colostrum on Toxicity and Inflammatory Responses During Treatment of Childhood Acute Lymphoblastic Leukaemia


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.


Inclusion Criteria:



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

Exclusion Criteria:

- Milk Allergy

- Lactose intolerance

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Days with fever. Fever

Outcome Description:

Days with temperature at or above 38.5 degrees celsius.

Outcome Time Frame:

Measured two times daily and on suspicion during the intervention period, up to four weeks,

Safety Issue:

No

Principal Investigator

Mathias Rathe, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University og Southern Denmark

Authority:

Denmark: Danish Dataprotection Agency

Study ID:

OUH-HCA-002

NCT ID:

NCT01766804

Start Date:

March 2013

Completion Date:

May 2015

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Acute Lymphoblastic Leukemia
  • Bovine Colostrum
  • Inflammation
  • Infection
  • Toxicity
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

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