CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 91 enrolled
Drug / intervention
sargramostim +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00293462
NCT00293462Phase 3Completed
CompareCT.gov

Management of Mucositis With GM-CSF (Sargramostim) Mouthwash Study Protocol

Marilyn Dodd·interventional·Posted Feb 17, 2006·Updated Jul 30, 2021

In Brief

A Phase 3 clinical trial evaluating sargramostim and oral salt and soda mouthwash for Head and Neck Cancer and 3 related conditions. Completed, enrolled 91 participants across 1 site.

Detailed Summary

GM-CSF may protect normal cells from the side effects, such as mucositis, of radiation therapy and may help damaged tissue heal faster after radiation therapy. This randomized clinical trial is studying how well GM-CSF works in preventing and treating mucositis in patients who are undergoing radiation therapy for head and neck cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead and Neck Cancer, Mucositis Oral, Radiation Toxicity, Tongue Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 17, 2006
Enrollment StartJun 7, 2005
Primary CompletionDec 31, 2009
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 20.4 years ago

Interventions

sargramostimbiological

oral salt and soda mouthwashother

Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily.