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

NCT02376985 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2019-10-21

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Oral management

DRUG

Everolimus

Sponsors & Collaborators

Principal Investigators

  • Akira Yamao · Public Health Research Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-26
Primary Completion
2018-03-31
Completion
2018-10-16

Countries

  • Japan

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02376985 on ClinicalTrials.gov