Effectiveness of probiotics against oral mucositis

JRCT ID: jRCTs061210028

Registered date:03/08/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Breast cancer
• Date of first enrollment: 24/08/2021
• Target sample size: 60
• Study type: Interventional

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 Outcome: Determining the severity of oral mucositis based on NCI-CTCAE ver5.0

Secondary Outcome

Pain 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 maximum: Not applicable
• Gender: Both

Include criteria

1.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 criteria

1.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

• Primary Sponsor: Kawaguchi Hiroyuki
• Source(s) of Monetary Support: KAKENHI(18K09880,20K100162)