Acute Lymphoblastic LeukemiaCALLNCT01766804
Effect of Bovine Colostrum on Toxicity and Inflammatory Responses
A study testing Bovine Colostrum in people with Acute Lymphoblastic Leukemia, run by Steffen Husby at 2 sites in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 45 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Bovine Colostrum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 2 sitesDenmark
- Study dates
- Mar 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients treated according to the Nordic Society of Pediatric Haematology and Oncology (NOPHO) ALL protocol
Who cannot join
- Milk Allergy
- Lactose intolerance
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Rigshospitalet
Copenhagen, 2100
Odense University Hospital
Odense, 5000
About this study
Official title: Effect of Bovine Colostrum on Toxicity and Inflammatory Responses During Treatment of Childhood Acute Lymphoblastic Leukaemia
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.
Read the detailed 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.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Bovine Colostrum, placebo
- Keywords
- Acute Lymphoblastic Leukemia, Bovine Colostrum, Inflammation, Infection, Toxicity
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Inflammation, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bovine ColostrumDietary supplement
Also called Colodan, Biodane-Pharma.
The intervention consists of daily bovine colostrum supplementation given during the induction treatment of ALL therapy for a total of four weeks.
placeboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Bovine colostrum | Experimental | A daily supplement of bovine colostrum powder. Receives: Dietary Supplement: Bovine Colostrum |
| Placebo | Placebo comparator | A daily placebo supplement consisting of whole milk powder and whey protein. Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days with fever. Fever
Days with temperature at or above 38.5 degrees celsius.
Measured: Measured two times daily and on suspicion during the intervention period, up to four weeks,
Secondary outcomes (7)
Days in intensive care unit
Number of days treated in an intensive care unit.
Measured: During the 4 week intervention period
Days in i.v. antibiotic treatment.
Number of days in intravenous antibiotic treatment during the intervention period.
Measured: During the 4 week intervention period.
Duration of cytopenia (neutrocytes <1,0 and platelets <20)
Measured: During the 4 week intervention period.
Proven or suspected infections
Episodes of suspected or culture positive sepsis number of documented septic events either culture proven or those treated with a course of antibiotics.
Measured: During the 4 week intervention period
Number of blood and platelet transfusions given during the course of treatment
Number of blood and platelet transfusions given during the course of treatment
Measured: During the 4 week intervention period.
Clinical and paraclinical indices of gastrointestinal toxicity
Clinical toxicity is scored using Common Toxicity Criteria for Adverse Effects (NCI-CTCAE), WHO and oral mucositis assessment scale (OMAS) grading schemes at inclusion and weekly during the treatment period. Furthermore the patients register toxicity using the oral mucositis daily questionaire(OMDQ).
Paraclinical indices are citruline, fecal calprotectin,
Measured: At base line and weekly during the 4 week intervention period. Up to 4 weeks.
Serologic markers for systemic inflammation
Serum will be taken weekly. Markers will include C reactive protein (CRP), procalcitonin (PCT), soluble urokinase plasminogen activator receptor (sUPAR), plasma cytokines and receptors (IL-6, IL-8, Soluble tumour necrosis factor receptors (sTNFR1), IL-1Ra).
Cytokine production in full blood cultures will be measured at day 3 and at day 24. Initial screening for a broad spectrum of cytokines will be performed in 5-10 patients. Based on these results a final panel of analyses comprising a narrower spectrum of cytokines will be determined and used for further investigation. These will include at least TNFR1, IL-1Ra, IL-6, IL-8.
Measured: Weekly and at day 3 and 24, up to 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steffen Husby
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Steffen Husby, Odense University Hospital
- Investigators
- Mathias Rathe, MD, Principal investigator, University og Southern DenmarkSteffen Husby, MD, DMSc, Study chair, Odense University HospitalKlaus Müller, MD, DMSc, Study chair, Copenhagen University Hospital, RigshospitaletPeder S Wehner, MD, PhD, Study chair, Odense University HospitalPer T Sangild, DVSc, DMSc, Study chair, Department of Human Nutrition, Faculty of Life Science, University of Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01766804
- Sponsor's protocol ID
- OUH-HCA-002
- Acronym
- CALL
- Status last verified
- Jul 2018
- First submitted
- 9 Jan 2013
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Rathe M, De Pietri S, Wehner PS, Frandsen TL, Grell K, Schmiegelow K, Sangild PT, Husby S, Muller K. Bovine Colostrum Against Chemotherapy-Induced Gastrointestinal Toxicity in Children With Acute Lymphoblastic Leukemia: A Randomized, Double-Blind, Placebo-Controlled Trial. JPEN J Parenter Enteral Nutr. 2020 Feb;44(2):337-347. doi: 10.1002/jpen.1528. Epub 2019 Mar 12.
PubMed 30861163Shen RL, Pontoppidan PE, Rathe M, Jiang P, Hansen CF, Buddington RK, Heegaard PM, Muller K, Sangild PT. Milk diets influence doxorubicin-induced intestinal toxicity in piglets. Am J Physiol Gastrointest Liver Physiol. 2016 Aug 1;311(2):G324-33. doi: 10.1152/ajpgi.00373.2015. Epub 2016 Jul 21.
PubMed 27445347
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bovine Colostrum on Toxicity and Inflammatory Responses During Treatment of Childhood Acute Lymphoblastic Leukaemia
- ClinicalTrials.gov ID
- NCT01766804
- Acronym / sponsor ID
- CALL / OUH-HCA-002
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- Acute Lymphoblastic Leukemia, Bovine Colostrum, Inflammation, Infection, Toxicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Steffen HusbyUniversity, hospital or other
- Collaborators
- University of Southern Denmark, Copenhagen University Hospital, Rigshospitalet
- Study start
- Mar 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bovine colostrum | Experimental | Dietary Supplement: Bovine ColostrumA daily supplement of bovine colostrum powder. |
| Placebo | Placebo comparator | Dietary Supplement: placeboA daily placebo supplement consisting of whole milk powder and whey protein. |
Who may qualify
- Ages
- 1 year to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients treated according to the Nordic Society of Pediatric Haematology and Oncology (NOPHO) ALL protocol
Key exclusion criteria (2 listed)
- Milk Allergy
- Lactose intolerance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bovine ColostrumAlso: Colodan, Biodane-Pharma.The intervention consists of daily bovine colostrum supplementation given during the induction treatment of ALL therapy for a total of four weeks. | Dietary supplement | Bovine colostrum |
| placebo | Dietary supplement | Placebo |
Primary outcome
Days with fever. Fever
Time frame: Measured two times daily and on suspicion during the intervention period, up to four weeks,
Days with temperature at or above 38.5 degrees celsius.
7 secondary outcomes
Days in intensive care unit
Time frame: During the 4 week intervention period
Days in i.v. antibiotic treatment.
Time frame: During the 4 week intervention period.
Duration of cytopenia (neutrocytes <1,0 and platelets <20)
Time frame: During the 4 week intervention period.
Proven or suspected infections
Time frame: During the 4 week intervention period
Number of blood and platelet transfusions given during the course of treatment
Time frame: During the 4 week intervention period.
Clinical and paraclinical indices of gastrointestinal toxicity
Time frame: At base line and weekly during the 4 week intervention period. Up to 4 weeks.
Serologic markers for systemic inflammation
Time frame: Weekly and at day 3 and 24, up to 4 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- Derived from this study: PubMed 30861163Rathe M, De Pietri S, Wehner PS, Frandsen TL, Grell K, Schmiegelow K, Sangild PT, Husby S, Muller K. Bovine Colostrum Against Chemotherapy-Induced Gastrointestinal Toxicity in Children With Acute Lymphoblastic Leukemia: A Randomized, Double-Blind, Placebo-Controlled Trial. JPEN J Parenter Enteral Nutr. 2020 Feb;44(2):337-347. doi: 10.1002/jpen.1528. Epub 2019 Mar 12.
- Derived from this study: PubMed 27445347Shen RL, Pontoppidan PE, Rathe M, Jiang P, Hansen CF, Buddington RK, Heegaard PM, Muller K, Sangild PT. Milk diets influence doxorubicin-induced intestinal toxicity in piglets. Am J Physiol Gastrointest Liver Physiol. 2016 Aug 1;311(2):G324-33. doi: 10.1152/ajpgi.00373.2015. Epub 2016 Jul 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathias Rathe, MD principal investigator
University og Southern Denmark
Steffen Husby, MD, DMSc study chair
Odense University Hospital
Klaus Müller, MD, DMSc study chair
Copenhagen University Hospital, Rigshospitalet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bovine Colostrum in people with Acute Lymphoblastic Leukemia, run by Steffen Husby at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days with fever. Fever (time frame: Measured two times daily and on suspicion during the intervention period, up to four weeks,). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01766804, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2018.