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GM-CSF Mouthwash for Preventing and Treating Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer
Phase 3
Waitlist Available
Led By Marylin J. Dodd, RN, PhD
Research Sponsored by Marilyn Dodd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial
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.
Eligible Conditions
- Head and Neck Cancers
- Radiation Poisoning
- Oral Mucositis
- Tongue Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Comparison of Number of Participants With Grade 1 or 2 Oral Mucositis (GM-CSF and SS Groups Only)
Comparison of the Mean Number of Days for Mucositis to Heal Across by Group
Secondary study objectives
Comparison of Combined Mean Score on the Karnofsky Performance Status Scale (KPS) by Group
Comparison of Combined Mean Score on the Pain Questionnaire by Group
Comparison of the Combined Mean Score on the Overall Quality of Life Questionnaires by Group
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Active Control
Group I: Arm III: Salt & Soda Switched to GM-CSF (SG)Active Control2 Interventions
Arm III: Patients were randomized to receive oral salt and soda (SS) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving GM-CSF treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
Group II: Arm I: GM-CSF Group (GG)Active Control1 Intervention
Arm I: Patients were randomized to receive oral sargramostim (GM-CSF) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving GM-CSF treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
Group III: Arm II: Salt & Soda Group (SS)Active Control1 Intervention
Arm II: Patients were randomized to receive salt and soda (SS) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving SS treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,952 Previous Clinical Trials
41,111,880 Total Patients Enrolled
1 Trials studying Oral Mucositis
50 Patients Enrolled for Oral Mucositis
Marilyn DoddLead Sponsor
Marylin J. Dodd, RN, PhDPrincipal InvestigatorUniversity of California, San Francisco