NCT02376985

Evaluation of Oral Care to Prevent Oral Mucositis in ER Positive MBC Patients Treated With Everolimus: Phase 3 RCT

Evaluation of Oral Care to Prevent Oral Mucositis in Estrogen Receptor Positive Metastatic Breast Cancer Patients Treated With Everolimus: Phase III Randomized Control Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: Comprehensive Support Project for Oncology Research · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

To examine whether the occurrence of oral mucositis can be reduced by dental oral management in patients by comparing the use of dental oral management through instruction by dental and oral surgeons (dental oral management group) and an observation group (brushing instruction only group) in a randomized, controlled study in females that are using everolimus for estrogen receptor-positive, hormone therapy-resistant refractory breast cancer.

Detailed description

To examine whether the occurrence of oral mucositis can be reduced by dental oral management in patients by comparing the use of dental oral management through instruction by dental surgeons or oral surgeons (hereafter referred to as, "dental and oral surgeons") and an observation group in a randomized, controlled study in females that are using everolimus for estrogen receptor-positive, hormone therapy-resistant refractory breast cancer. The objectives of this study are as described below. 1. To examine whether the occurrence of oral mucositis can be reduced by implementing dental oral management prior to everolimus treatment. 2. To examine whether the frequency and duration of oral mucositis can be reduced and reductions in the dose of everolimus can be reduced by implementing dental oral management prior to everolimus treatment. 3. To examine whether treatment of oral mucositis of over Grade 1 with dexaltin ointment as dental oral management can reduce the occurrence of Grade 2 oral mucositis. 4. To evaluate the health-related quality of life (HRQOL) in a group that implements dental oral management prior to everolimus treatment and a group that does not. 5. To establish and strengthen cooperation and organize and expand and information distribution network through the participation of oncologists and specialists in breast cancer treatment (hereafter referred to as, "oncologists") and dental and oral surgeons in clinical studies.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Oral management
DRUG	Everolimus

Timeline

• Start date: 2015-03-26
• Primary completion: 2018-03-31
• Completion: 2018-10-16
• First posted: 2015-03-03
• Last updated: 2019-10-21

Locations

1 site across 1 country: Japan