Tokyo, Oct. 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059464) titled 'A single-arm phase II study evaluating the preventive effect of dental intervention on oral mucositis during the initiation of datopotamab deruxtecan in patients with advanced breast cancer' on Oct. 23.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Historical
Primary Sponsor:
Institute - Japan Institute for Health Security
Condition:
Condition - Breast cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate whether dental intervention can prevent the occurrence of oral mucositis induced by datopotamab deruxtecan(Dato-DXd).
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - The following dental interventions will be performed: evaluation of the oral environment, dental calculus removal, professional mechanical tooth cleaning (PMTC), toothbrushing instruction, tongue coating removal instruction, and gargling instruction.
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients diagnosed with breast cancer eligible for Dato-DXd under Japanese insurance coverage and scheduled to receive Dato-DXd treatment.
Key exclusion criteria - 1. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 3 or higher at the time of consent.
2. Patients who have oral mucositis at the time of consent.
3. Patients who are scheduled to undergo dental procedures involving polishing, puncture, incision, or local anesthesia at the time of consent.
4. Patients who wish to receive dental care at another institution.
Target Size - 35
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2025 Year 07 Month 17 Day
Date of IRB - 2025 Year 10 Month 14 Day
Anticipated trial start date - 2025 Year 10 Month 24 Day
Last follow-up date - 2029 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068012
Disclaimer: Curated by HT Syndication.
