Head-and-neck Cancer Clinical Trial
Official title:
Effects of Probiotics Intake on Oral Microbiome and Mucosa Inflammation in Patients With Cytotoxic Therapy Induced Oral Mucositis: A Pilot Study
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.
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.
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