NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs061210028

Registered date:03/08/2021

Effectiveness of probiotics against oral mucositis

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedBreast cancer
Date of first enrollment24/08/2021
Target sample size60
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)(Ingest group) One ProDentis MUM tablet is dissolved in the bowl twice a day during breakfast and after meals. Always check the patient diary to make sure it has not been taken. Check the box after each ingests. If a missed ingest is noticed within 4 hours of the ingest time, it should be taken immediately. If more than 4 hours have passed, the patient should not take it that time but resume regular ingestion the next time. If more than four hours have passed, do not take it on that occasion and continue taking it as usual on the next event. (Non-ingest group) No ingest

Outcome(s)

Primary OutcomeDetermining the severity of oral mucositis based on NCI-CTCAE ver5.0
Secondary OutcomePain scale numerical rating scale (NRS) Score the oral cavity using two oral assessments PISA: Periodontal inflamed surface area Number of oral bacteria Oral dryness (saliva test and mucus measurement) Time to first appearance of oral mucositis (using the patient diary record) Duration of each grade of oral mucositis (Evaluation by a single evaluator using patient diary records) Oral microbiome analysis (Saliva and gingival plaque from all subjects) Inflammatory cytokines in saliva

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1.Age 20 years or older at the time of obtaining consent 2.Those who are scheduled to receive chemotherapy for breast cancer. (docetaxel therapy : using docetaxel or TC therapy: using paclitaxel and carboplatin, not limited to the first treatment) 3.Those who have Grade 1 or less of oral mucositis due to other chemotherapeutic agents within the pre-observation period. 4.Those who can provide written consent for participation in this study
Exclude criteria1.Those who have taken a probiotic preparation within the last 3 months prior to the start of the study.(General lactic acid bacteria preparations such as yogurt are excluded.) 2.Those who have had serious side effects with probiotic pre parations in the past 3.Those who develop oral mucositis due to physical irritation such as dental caries, non-conforming prosthesis 4.Any person who, while participating in this research, participates in any other clinical research using the food or research procedures being studied 5.Any other person deemed inappropriate by the principal investigator or sub-investigator

Related Information

Contact

Public contact
Name Hiromi Nishi
Address 1-2-3 Kasumi Minami-ku Hiroshima Hiroshima Japan 734-8551
Telephone +81-82-257-5744
E-mail hiyoko@hiroshima-u.ac.jp
Affiliation Hiroshima University hospital
Scientific contact
Name Hiroyuki Kawaguchi
Address 1-2-3 Kasumi Minami-ku Hiroshima Hiroshima Japan 734-8551
Telephone +81-82-257-5744
E-mail hkawarp@hiroshima-u.ac.jp
Affiliation Hiroshima University Hospital