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Effects of Probiotics in Preventing Oral Mucositis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03552458
Recruitment Status : Recruiting
First Posted : June 11, 2018
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
National University Hospital, Singapore

Tracking Information
First Submitted Date  ICMJE April 15, 2018
First Posted Date  ICMJE June 11, 2018
Last Update Posted Date April 30, 2019
Actual Study Start Date  ICMJE June 26, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2018)
  • Oral Mucositis (OM) Severity Assessment [ Time Frame: Weekly review from baseline (Day 1 of Radiation) to 14 days after last radiation treatment ]
    To assess the severity of OM using Oral Mucositis Assessment Scale (OMAS)
  • Oral Mucositis (OM) Severity Assessment [ Time Frame: Weekly review from baseline (Day 1 of Radiation) to 14 days after last radiation treatment ]
    To assess the severity of OM (Grade 0-4) using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0
  • Duration of Oral Mucositis (OM) [ Time Frame: Weekly review from baseline (Day 1 of Radiation) to 14 days after last radiation treatment ]
    To assess the number of days of OM experienced i.e. start of OM still resolution of OMM
  • Pain Severity of OM [ Time Frame: Weekly review from baseline (Day 1 of Radiation) to 14 days after last radiation treatment ]
    Visual Analogue Scale (0-10)
  • Quality of Life post Radiation [ Time Frame: Daily Patient Completed Questionnaire from baseline (Day 1 of Radiation) to 14 days after last radiation treatment ]
    Composite score using the Oral Mucositis Daily Questionnaire (8 Item questionnaire)
Original Primary Outcome Measures  ICMJE
 (submitted: May 29, 2018)
  • Oral Mucositis (OM) Severity Assessment [ Time Frame: Weekly review from baseline (Day 1 of Radiation) to 14 days after last radiation treatment ]
    To assess the severity of OM using Oral Mucositis Assessment Scale (OMAS)
  • Oral Mucositis (OM) Severity Assessment [ Time Frame: Weekly review from baseline (Day 1 of Radiation) to 14 days after last radiation treatment ]
    To assess the severity of OM (Grade 0-4) using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0
  • Duration of Oral Mucositis (OM) [ Time Frame: Weekly review from baseline (Day 1 of Radiation) to 14 days after last radiation treatment ]
    To assess the number of days of OM experienced i.e. start of OM still resolution of OMM
  • Pain Severity of OM [ Time Frame: Weekly review from baseline (Day 1 of Radiation) to 14 days after last radiation treatment ]
    Visual Analogue Scale (0-10)
  • Quality of Life [ Time Frame: Daily Patient Completed Questionnaire from baseline (Day 1 of Radiation) to 14 days after last radiation treatment ]
    Composite score using the Oral Mucositis Daily Questionnaire (8 Item questionnaire)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2018)
Oral Bacteria Analysis and Gene Expression Analysis [ Time Frame: Change between baseline and Week 4 ]
Oral samples will be collected at 2 time points: baseline (before start of head and neck radiotherapy) and at week 4 (Visit 5, midpoint) of radiotherapy.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Probiotics in Preventing Oral Mucositis
Official Title  ICMJE Effects of Probiotics Intake on Oral Microbiome and Mucosa Inflammation in Patients With Cytotoxic Therapy Induced Oral Mucositis: A Pilot Study
Brief Summary The study will be a randomized double blind prospective placebo controlled clinical study and aims to determine the therapeutic efficacy of Probiotics in Oral Mucositis pathogenesis in patients undergoing head and neck radiotherapy.
Detailed Description

The study will be a randomized double blind prospective placebo controlled clinical study (Clinical Trial phase II) of 50 patients (25 in LR group, 25 in placebo group) with a confirmed cancer diagnosis requiring head and neck radiotherapy with a minimum dose of 6000cGy.

Patients will be randomly assigned to either of the treatment arms in a 1:1 ratio. The active agent; Lactobacillus reuteri Prodentis (Biogaia ®) will be supplied in droplet form by Pharma forte Singapore Pte Ltd and dosage used will be as recommended by manufacturer (5 drops/time twice a day which is equivalent to 4 X 108 CFU of live bacteria). The control agent will be identical in physical appearance and color to the study agent and will be made by the manufacturer.

Patients assigned to either LR group or placebo group will start from the first day of radiotherapy and continued until 2-week post radiation (approximately 8-9 weeks). Patients will be instructed to use the LR droplets twice a day according to manufacturer's instructions; once in the morning after breakfast and the other just before bedtime and to avoid any food/drinks 30 minutes before and after usage. Compliance with treatment will be elicited and recorded.

The dose selection is based on manufacturer's recommendations and is safe for use during pregnancy and breastfeeding. However, this is not an issue in this population as none of the patients should be pregnant or breastfeeding while receiving radiation and anti-neoplastic chemotherapy.

The PI will serve as the auditor for data quality assurance on a quarterly basis.Data collected on paper will be stored in the principal investigator's locked cabinet. Data will be entered into Microsoft Excel™ (2007) and double entered for accuracy. Data will be kept in a password secured portable computer and backed up to dedicated local back-up drive every week. Only group statistics will be reported. The database will only be accessible to investigators involved in and approved for the study. All data will be kept for 6 years after study completion to access data for publication of the work done, after which data will be destroyed.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
randomized double blind prospective placebo controlled clinical study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Head-and-neck Cancer
Intervention  ICMJE
  • Drug: Lactobacillus Reuteri Oral Solution [BioGaia]
    BioGaia Lactobacillus Reuteri drops
    Other Name: Biogaia Prodentis
  • Drug: Placebos
    Placebo will be identical in physical appearance and color to the study agent and will be made by the manufacturer
    Other Name: Placebo
Study Arms  ICMJE
  • Experimental: LR group
    Lactobacillus Reuteri Oral Solution [BioGaia]
    Intervention: Drug: Lactobacillus Reuteri Oral Solution [BioGaia]
  • Placebo Comparator: Placebo group
    Placebos: The control agent will not contain the active agent
    Intervention: Drug: Placebos
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 29, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. patients who are 21 years of age or older
  2. histological diagnosis of head and neck carcinoma available
  3. undergoing head and neck radiotherapy of at least 6000cGY
  4. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
  5. no known allergy to Biogaia
  6. able to give written informed consent, or have written consent given on their behalf.

Exclusion Criteria:

  1. patients who cannot use the products or have it administered to them
  2. patients with existing conditions predisposing to oral ulcer formation
  3. patients with mucositis at baseline (prior to initiation of treatment)
  4. previous radiotherapy to the head and neck region
  5. female patients who are pregnant or breastfeeding
  6. patients who have central venous catheters
  7. patients who have impaired intestinal epithelial barrier
  8. patients who have cardiac valvular disease
  9. unable to give written informed consent, or are unable to have written consent given on their behalf.
  10. inability to converse in English or Mandarin
  11. severe immunosuppression (Absolute Neutrophil Count of less than 1500 cells/µL)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Catherine Hong, Master 65-6779 5555 ext 1787 denchhl@nus.edu.sg
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03552458
Other Study ID Numbers  ICMJE 2017/00508
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party National University Hospital, Singapore
Study Sponsor  ICMJE National University Hospital, Singapore
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Catherine Hong National University Hospital, Singapore
PRS Account National University Hospital, Singapore
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP