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Mucositis and Infection Reduction With Liquid Probiotics in Children With Cancer (MaCROS)

Primary Purpose

Pediatric Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Probiotic
Placebo
Sponsored by
University of Leeds
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pediatric Cancer focused on measuring pediatric, cancer, malignant haematology, transplant, probiotics, mucositis, infection, supportive care

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients between the ages of 1 and 18 treated on paediatric cancer protocols receiving chemotherapy on regimens likely to cause mucositis.

Exclusion Criteria:

Patients who have already started the course of chemotherapy. Patients receiving radiotherapy or surgery alone. Patients diagnosed with an immunodeficiency (excluding IgA). Patients who have previously taken probiotics within the month prior to commencing the course of chemotherapy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Probiotic

    Placebo

    Arm Description

    Participants will start the course of liquid probiotic on the first day of their course of chemotherapy. This can be taken orally, or using an nasogastric or gastrostomy tube and will continue this for 14 days. Doses will be adjusted according to the age of the participant as follows: 1-4 years:20ml once a day 4-11 years: 0.5ml/kg once a day 12-18 years: 1ml/kg once a day

    Participants will start the course placebo on the first day of their course of chemotherapy. This can be taken orally or using an nasogastric or gastrostomy tube and will continue this for 14 days. Doses will be adjusted according to the age of the participant as follows: 1-4 years:20ml once a day 4-11 years: 0.5ml/kg once a day 12-18 years: 1ml/kg once a day Placebo will be delivered in similar, packaging, appearance and taste.

    Outcomes

    Primary Outcome Measures

    Recruitment
    Proportion of eligible participants successfully recruited to the MaCROS study
    Recruitment
    Proportion and number of eligible participants successfully recruited to the MaCROS study
    Compliance of taking the probiotic/placebo
    Proportion of participants who are able to complete the 14 day course
    Compliance of filling in the paper/web-app diary
    Proportion of participants who are able to fill in and return the diary for 21 days
    Cost-benefit evaluation of the study
    Cost-benefit analysis of undertaking the study

    Secondary Outcome Measures

    Incidence of mucositis in both groups
    Proportion of participants who develop mucositis in both groups.
    Comparison of mucositis in both groups
    Mean difference of mucositis (if possible) between both groups
    Proportion of participants who develop fever
    Proportion of participants who develop fever Mean difference of fever (if possible) between both groups
    Evaluate responsible guardian/participants experience of the MaCROS study
    This optional part of the study will be done by undertaking recorded telephone or face to face interview

    Full Information

    First Posted
    December 5, 2018
    Last Updated
    December 21, 2018
    Sponsor
    University of Leeds
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03785938
    Brief Title
    Mucositis and Infection Reduction With Liquid Probiotics in Children With Cancer
    Acronym
    MaCROS
    Official Title
    Mucositis and Infection Reduction With Liquid Probiotics in Children With Cancer: a Randomised-controlled Feasibility Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 20, 2019 (Anticipated)
    Primary Completion Date
    July 20, 2019 (Anticipated)
    Study Completion Date
    August 20, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Leeds

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study is to evaluate the feasibility of an randomised-controlled trial to investigate the efficacy of liquid probiotics to prevent or reduce mucositis and infection in children diagnosed with cancer who are undergoing treatment with regimes likely to cause mucositis.
    Detailed Description
    TRIAL DESIGN This will be a single-centre double-blind randomised-controlled feasibility study. TRIAL SETTING This study will take place at Leeds Teaching Hospital Trust (LTHT), Leeds UK. Participants will be approached whilst admitted as inpatients (typically the paediatric haematology oncology wards) and during outpatient clinics. METHOD Allocation sequence from a randomisation schedule will be generated A screening or trial ID number will be assigned to each participant. The allocation sequence will be concealed from health care professionals, participants and families. Only the pharmacy team involved in randomisation, allocation will not be blinded to allocation sequence and generation. Following identification, confirmation of eligibility, consent and allocation of trial ID of the participant, a prescription will be produced and the probiotic or placebo will be allocated accordingly. Appearance of the intervention and placebo will be similar in appearance, smell and taste. The placebo will include maltdextrin (a polysaccharide). Both the probiotic and placebo will be produced by the company Symprove. Participants will start the course of probiotic or placebo on the first day of their course of chemotherapy orally, or using an nasogastric or gastrostomy tube and will continue this for 14 days. Doses will be adjusted according to the age of the participant as follows: 1-4 years:20ml once a day 4-11 years: 0.5ml/kg once a day 12-18 years: 1ml/kg once a day Placebo will be delivered in similar, packaging, appearance and taste. Participants or their parents will be asked to fill in a diary (paper or electronic using a web-app) daily for 21 days in total. The diary will include questions to assess nausea, vomiting, diarrhoea, pain and oral mucositis. An example of the patient diaries offered is supplied. Either the participant or parent will fill in the diary on a daily basis for a minimum of 21 days. The web-app is an electronic version of the paper diary. Participants will to chose their preferred method. Participants will be given the URL which they can download onto their phone as a web-app. Data provided by participants in the web-app will only be identified by their unique identification number and information will be transferred to an excel spread sheet. Clinical records including electronic and written records will be reviewed to investigate any febrile episodes and infections for incidence and duration of fever/infection and duration of hospital stay until afebrile for 48 hrs. Any data collected from clinical records will be stored on an excel web sheet which will be kept on an NHS computer. Data on the excel spreadsheet will be identified using their unique identification number. Data will be collected and analysed on an NHS computer. The person collecting the data (the principal investigator) is also a member of the health care team and has access to clinical records as part of routine care. Participants will be invited to participate in an optional interview exploring their experiences in taking part in the study. This will take up to 45 minutes and can be done over the phone or in person whilst in the hospital. The interviews will be recorded using an encrypted digital audio recorder. Participants who chose to decline will also be invited to a short optional interview exploring why they chose to decline. This will approximately be a 10 minute discussion which will take place when the participant/their parent disclose they have decided to decline and will only take place if both the participant/parent and interviewer (the chief investigator) is present in the hospital.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pediatric Cancer
    Keywords
    pediatric, cancer, malignant haematology, transplant, probiotics, mucositis, infection, supportive care

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Double blinded randomised-controlled feasibility study
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    The liquid probiotic/placebo will be blinded by the pharmacy team and LTHT
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Probiotic
    Arm Type
    Experimental
    Arm Description
    Participants will start the course of liquid probiotic on the first day of their course of chemotherapy. This can be taken orally, or using an nasogastric or gastrostomy tube and will continue this for 14 days. Doses will be adjusted according to the age of the participant as follows: 1-4 years:20ml once a day 4-11 years: 0.5ml/kg once a day 12-18 years: 1ml/kg once a day
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants will start the course placebo on the first day of their course of chemotherapy. This can be taken orally or using an nasogastric or gastrostomy tube and will continue this for 14 days. Doses will be adjusted according to the age of the participant as follows: 1-4 years:20ml once a day 4-11 years: 0.5ml/kg once a day 12-18 years: 1ml/kg once a day Placebo will be delivered in similar, packaging, appearance and taste.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Probiotic
    Other Intervention Name(s)
    Symprove liquid probiotic
    Intervention Description
    Liquid probiotic supplied by the company Symprove
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo made of maltdextrin. Will be similar in taste and consistency
    Primary Outcome Measure Information:
    Title
    Recruitment
    Description
    Proportion of eligible participants successfully recruited to the MaCROS study
    Time Frame
    6 months
    Title
    Recruitment
    Description
    Proportion and number of eligible participants successfully recruited to the MaCROS study
    Time Frame
    6 months
    Title
    Compliance of taking the probiotic/placebo
    Description
    Proportion of participants who are able to complete the 14 day course
    Time Frame
    6 months
    Title
    Compliance of filling in the paper/web-app diary
    Description
    Proportion of participants who are able to fill in and return the diary for 21 days
    Time Frame
    6 months
    Title
    Cost-benefit evaluation of the study
    Description
    Cost-benefit analysis of undertaking the study
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Incidence of mucositis in both groups
    Description
    Proportion of participants who develop mucositis in both groups.
    Time Frame
    6 months
    Title
    Comparison of mucositis in both groups
    Description
    Mean difference of mucositis (if possible) between both groups
    Time Frame
    6 months
    Title
    Proportion of participants who develop fever
    Description
    Proportion of participants who develop fever Mean difference of fever (if possible) between both groups
    Time Frame
    6
    Title
    Evaluate responsible guardian/participants experience of the MaCROS study
    Description
    This optional part of the study will be done by undertaking recorded telephone or face to face interview
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients between the ages of 1 and 18 treated on paediatric cancer protocols receiving chemotherapy on regimens likely to cause mucositis. Exclusion Criteria: Patients who have already started the course of chemotherapy. Patients receiving radiotherapy or surgery alone. Patients diagnosed with an immunodeficiency (excluding IgA). Patients who have previously taken probiotics within the month prior to commencing the course of chemotherapy.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hadeel Hassan, MBChB MSc
    Phone
    01133432596
    Ext
    01133432596
    Email
    umhh@leeds.ac.uk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bob Phillips, MBChB PhD
    Phone
    01904321099
    Ext
    01133432596
    Email
    bob.phillips@york.ac.uk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hadeel Hassan, MBCHB MSc
    Organizational Affiliation
    University of Leeds
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    34193407
    Citation
    Hassan H, Kinsey S, Phillips B. Mucositis reduction with probiotics in children with cancer: a randomised-controlled feasibility study. Arch Dis Child. 2022 Mar;107(3):259-264. doi: 10.1136/archdischild-2020-319968. Epub 2021 Jun 30.
    Results Reference
    derived

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    Mucositis and Infection Reduction With Liquid Probiotics in Children With Cancer

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