18 and older, any sex, with Head and Neck Cancer or Mucositis Oral. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Comparison of Number of Participants With Grade 1 or 2 Oral Mucositis (GM-CSF and SS Groups Only)Primary· From baseline to onset of mucositis, approximately 16 days
The number of participants with recorded grade 1 (mild; Irritation, may experience slight pain, not requiring analgesic) or grade 2 (moderate; Patchy mucositis that may produce inflammatory serosanguinitis discharge; may experience moderate pain requiring analgesia) oral mucositis using the Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria Oral Mucosa Assessment Scale at baseline and during radiotherapy will be recorded. The RTOG grading is reliant on a clinician's ability to judge the anatomical changes associated with oral mucositis (size and characteristics
Group
Value
95% CI
Arm I: GM-CSF Group (GG)
28
Arm II: Salt & Soda Group (SS)
46
Comparison of the Mean Number of Days for Mucositis to Heal Across by GroupPrimary· From onset of mucositis to healing of mucositis, approximately 80 days
The mean number of days for mucositis to heal will be used to evaluate the effectiveness of the two mouthwashes in treating oral mucositis as defined by the incidence of Radiation Therapy Oncology Group Acute Radiation Morbidity Scoring.
Group
Value
95% CI
Arm I: GM-CSF Group (GG)
81.5
± 63.43
Arm II: Salt & Soda Group (SS)
79.4
± 31.24
Arm III: Salt & Soda Switched to GM-CSF (SG)
77.4
± 37.40
Comparison of the Combined Mean Score on the Overall Quality of Life Questionnaires by GroupSecondary· Up to 3 months
Quality of life at baseline, during radiotherapy, and once a month for 3 months after radiotherapy. The items on the quality of life questionnaire developed for the study range in scores from 0-10 with higher scores indicating a better quality of life. Scores at all time points were combined to compute one mean score for overall quality of life during the study.
Group
Value
95% CI
Arm I: GM-CSF Group (GG)
6.91
± 1.59
Arm II: Salt & Soda Group (SS)
6.80
± 1.46
Arm III: Salt & Soda Switched to GM-CSF (SG)
6.77
± 1.53
Comparison of Combined Mean Score on the Karnofsky Performance Status Scale (KPS) by GroupSecondary· Up to 3 months
Functional status of participants was measured by administering the KPS which contains items asking about performing daily activities. The scores are grouped in 10s ranging from 100 (Normal, no complaints) to 0 (Dead), with higher scores indicating better functional status. The KPS was administered at baseline, during radiotherapy, and once a month for 3 months after radiation therapy. Scores at all time points were combined to compute one mean to determine overall performance status during the course of the study.
Group
Value
95% CI
Arm I: GM-CSF Group (GG)
84.52
± 12.61
Arm II: Salt & Soda Group (SS)
82.93
± 10.92
Arm III: Salt & Soda Switched to GM-CSF (SG)
83.49
± 12.49
Comparison of Combined Mean Score on the Pain Questionnaire by GroupSecondary· Up to 3 months
Severity and quality of pain was measured using a pain questionnaire developed for this study with total scores ranging from 0 (no pain) to 10 (most intense pain) with higher scores indicating a greater level of pain. The questionnaire was administered at baseline, during radiotherapy, and once a month for 3 months after radiotherapy. Scores at all time points were combined to compute one mean to determine overall pain intensity score during the course of the study
Group
Value
95% CI
Arm I: GM-CSF Group (GG)
2.15
± 2.40
Arm II: Salt & Soda Group (SS)
1.72
± 2.26
Arm III: Salt & Soda Switched to GM-CSF (SG)
2.15
± 2.65
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 3 months.
Reporting threshold: 3%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Currently open trials in the same condition.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Marilyn Dodd
Last refreshed: 30 July 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00293462.