MedTrace Logo

Dexamethasone in Reducing Everolimus-Induced Oral Stomatitis in Patients With Cancer

NCT03839940 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2025-01-29

Study results available
· View outcomes & findings →

Summary

This phase III trial studies how well dexamethasone works in reducing everolimus-induced oral stomatitis in patients with cancer. Dexamethasone may help to reduce the everolimus-induced oral stomatitis so as to improve quality of life in cancer patients.

Conditions

  • Malignant Neoplasm

Interventions

DRUG

Dexamethasone

Given as mouthwash

OTHER

Placebo

Given as mouthwash

OTHER

Questionnaire

Ancillary studies

OTHER

Quality-of-Life Assessment

Ancillary studies

DRUG

Everolimus

Standard of care

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Alliance for Clinical Trials in Oncology

    lead OTHER

Principal Investigators

  • Kathryn Ruddy, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-03
Primary Completion
2021-01-08
Completion
2022-08-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT03839940 on ClinicalTrials.gov