Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00293462
Status:
COMPLETED
Last Update Posted:
2021-07-30
First Post:
2006-02-16
Brief Title:
GM-CSF Mouthwash for Preventing and Treating Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer
Sponsor:
Marilyn Dodd
Organization:
University of California San Francisco
Study Overview
Official Title:
Management of Mucositis With GM-CSF Sargramostim Mouthwash Study Protocol
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
OBJECTIVES
Primary
Compare the incidence of radiotherapy RT-induced oral mucositis of any grade using the Radiation Therapy Oncology Group Acute Radiation Morbidity Scoring Criteria RTOG ARMSC-Mucous Membrane in patients treated with 1 of 2 mouthwashes sargramostim GM-CSF or salt and soda prevention portion of the study
Compare the effectiveness of the 2 mouthwashes in treating oral mucositis as defined by the incidence of RTOG ARMSC-Mucous Membrane grade 3 and 4 mucositis in patients in 1 of 3 groups salt and soda continuing GM-CSF or new GM-CSF treatment portion of the study
Secondary
Compare the effectiveness of the 2 mouthwashes in preventing RT-induced oral mucositis by the following direct indices
Cumulative RT dose prior to onset of oral mucositis prevention portion only
Severity of RT-induced oral mucositis at onset and during treatment using Oral Mucositis Assessment Scale OMAS
Severity of oral mucositis-related pain at onset and during treatment using OMAS
Incidence of oral mucositis-related infection at onset and during treatment using OMAS
Severity of oral mucositis-related problems with ingestion of food and fluids at onset and during treatment using OMAS
Time to healing of RT-induced oral mucositis
Evaluate patients using the following indirect indices of oral mucositis morbidity during the prevention and treatment portions of the study
Tolerance to RT regimen
Functional status
Quality of life
OUTLINE This is a multicenter randomized controlled double-blinded study Patients are stratified according to radiotherapy dose schedule standard vs hyperfractionation vs intensity modulation and concurrent chemotherapy yes vs no
Prevention no mucositis Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral sargramostim GM-CSF mouthwash holding it in their mouths and swallowing it in intervals over 1 hour once daily
Arm II Patients receive oral salt and soda mouthwash holding it and swallowing it in intervals over 1 hour once daily
Treatment in both arms continues during 6-7 weeks of radiotherapy andor the onset of mucositis Patients also perform PRO-SELF Mouth Aware PSMA twice daily
Treatment onset of mucositis Patients who are currently using GM-CSF mouthwash continue use as in prevention Patients who are currently using salt and soda mouthwash are randomized to 1 of 2 treatment arms
Arm III Patients receive GM-CSF mouthwash as in arm I
Arm IV Patients receive salt and soda mouthwash as in arm II In both arms treatment continues until the mucositis heals Patients perform PSMA four times daily during and for 3 months after radiotherapy
Quality of life is assessed at baseline and periodically after radiotherapy
After completion of study treatment patients are followed every once a month for 3 months
Primary
Compare the incidence of radiotherapy RT-induced oral mucositis of any grade using the Radiation Therapy Oncology Group Acute Radiation Morbidity Scoring Criteria RTOG ARMSC-Mucous Membrane in patients treated with 1 of 2 mouthwashes sargramostim GM-CSF or salt and soda prevention portion of the study
Compare the effectiveness of the 2 mouthwashes in treating oral mucositis as defined by the incidence of RTOG ARMSC-Mucous Membrane grade 3 and 4 mucositis in patients in 1 of 3 groups salt and soda continuing GM-CSF or new GM-CSF treatment portion of the study
Secondary
Compare the effectiveness of the 2 mouthwashes in preventing RT-induced oral mucositis by the following direct indices
Cumulative RT dose prior to onset of oral mucositis prevention portion only
Severity of RT-induced oral mucositis at onset and during treatment using Oral Mucositis Assessment Scale OMAS
Severity of oral mucositis-related pain at onset and during treatment using OMAS
Incidence of oral mucositis-related infection at onset and during treatment using OMAS
Severity of oral mucositis-related problems with ingestion of food and fluids at onset and during treatment using OMAS
Time to healing of RT-induced oral mucositis
Evaluate patients using the following indirect indices of oral mucositis morbidity during the prevention and treatment portions of the study
Tolerance to RT regimen
Functional status
Quality of life
OUTLINE This is a multicenter randomized controlled double-blinded study Patients are stratified according to radiotherapy dose schedule standard vs hyperfractionation vs intensity modulation and concurrent chemotherapy yes vs no
Prevention no mucositis Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral sargramostim GM-CSF mouthwash holding it in their mouths and swallowing it in intervals over 1 hour once daily
Arm II Patients receive oral salt and soda mouthwash holding it and swallowing it in intervals over 1 hour once daily
Treatment in both arms continues during 6-7 weeks of radiotherapy andor the onset of mucositis Patients also perform PRO-SELF Mouth Aware PSMA twice daily
Treatment onset of mucositis Patients who are currently using GM-CSF mouthwash continue use as in prevention Patients who are currently using salt and soda mouthwash are randomized to 1 of 2 treatment arms
Arm III Patients receive GM-CSF mouthwash as in arm I
Arm IV Patients receive salt and soda mouthwash as in arm II In both arms treatment continues until the mucositis heals Patients perform PSMA four times daily during and for 3 months after radiotherapy
Quality of life is assessed at baseline and periodically after radiotherapy
After completion of study treatment patients are followed every once a month for 3 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01CA107080 | NIH | University of California San Francisco | httpsreporternihgovquickSearch5R01CA107080 |
| UCSF-H452-26184-03 | OTHER | None | None |
| 02802 | OTHER | None | None |