CompletedPhase 3

GM-CSF Mouthwash for Preventing and Treating Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer

United States91 participantsStarted 2005-06-07

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria * Histopathologically confirmed diagnosis of head and neck cancer * Scheduled to undergo continuous course of conventional or hyperfractionated radiotherapy or intensity-modulated radiotherapy (IMRT) with or without concurrent chemotherapy * Planning to receive a total radiation dose ≥ 5,500 centigray (cGy), administered in a single daily fraction of 180-220 cGy (5 days a week) or twice daily fractions of 110-150 cGy * Normal baseline oral examinations (no pre-existing lesion) * Karnofsky performance status 60-100% * Mentally capable of participating in research protocol * Expected survival \> 4.5 months * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Creatinine ≤ 2.0 mg/dL * Bilirubin ≤ 2.0 mg/dL * Aspartate aminotransferase (AST) \< 5 times upper limit of normal * HIV negative Exclusion Criteria * No unresolved adverse event from previous therapy * No prior radiotherapy to the head and neck * No prior or concurrent brachytherapy * No prior participation in this study * No T1 or T2 glottic tumors * No other serious concurrent medical illness * No history of insulin-dependent diabetes mellitus * No prior hypersensitivity reaction to yeast material * No recent history of oral ulceration, herpes simplex, oral candidiasis, severe gingivitis, active or chronic mucositis, or xerostomia * No current New York Heart Association class II-IV congestive heart failure * Not pregnant or nursing * No chemotherapy, radiotherapy, or other in…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Comparison of Number of Participants With Grade 1 or 2 Oral Mucositis (GM-CSF and SS Groups Only)

Timeframe: From baseline to onset of mucositis, approximately 16 days

Comparison of the Mean Number of Days for Mucositis to Heal Across by Group

Timeframe: From onset of mucositis to healing of mucositis, approximately 80 days

Trial details

NCT IDNCT00293462

SponsorMarilyn Dodd

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-12-31

Results submitted2013-03-27

View on ClinicalTrials.gov More Head and Neck Cancer trials