Trial · NCT00293462
GM-CSF Mouthwash for Preventing and Treating Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer
NCT00293462, Phase 3, Completed, Marilyn Dodd; results first posted 2013-05-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. GM-CSF Mouthwash for Preventing and Treating Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer. Trials, record NCT00293462. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00293462
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- GM-CSF Mouthwash for Preventing and Treating Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer
- NCT number
- NCT00293462
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 91 participants, actual
- Lead sponsor
- Marilyn Dodd
- Conditions
- Head and Neck Cancer, Mucositis Oral, Radiation Toxicity, Tongue Cancer
- Interventions
- sargramostim, oral salt and soda mouthwash
- First posted
- 2006-02-17
- Last updated
- 2021-07-30
- Results first posted
- 2013-05-16
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Comparison of Number of Participants With Grade 1 or 2 Oral Mucositis (GM-CSF and SS Groups Only) | 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 of ulceration), with symptoms ranging from Grade 0 (no symptoms) to Grade 4 (Ulceration, hemorrhage, or necrosis). A comparison of incidence in the GM-CSF Group (GG) and Arm II: Salt \& Soda Group (SS) will be reported. |
| Primary | Comparison of the Mean Number of Days for Mucositis to Heal Across by Group | 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. |
| Secondary | Comparison of the Combined Mean Score on the Overall Quality of Life Questionnaires by Group | 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. |
| Secondary | Comparison of Combined Mean Score on the Karnofsky Performance Status Scale (KPS) by Group | 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. |
| Secondary | Comparison of Combined Mean Score on the Pain Questionnaire by Group | 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 |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Comparison of Number of Participants With Grade 1 or 2 Oral Mucositis (GM-CSF and SS Groups Only) | From baseline to onset of mucositis, approximately 16 days | Intent to treat population consisted of randomized subjects who completed baseline questionnaire and had at least one dose of mouthwash | participants | NUMBER |
| PRIMARY | Comparison of the Mean Number of Days for Mucositis to Heal Across by Group | From onset of mucositis to healing of mucositis, approximately 80 days | Intent to treat population consisted of randomized subjects who completed baseline questionnaire and had at least one dose of mouthwash | days | MEAN |
| SECONDARY | Comparison of the Combined Mean Score on the Overall Quality of Life Questionnaires by Group | Up to 3 months | Of the intent to treat population, subjects who did not fill out the baseline quality of life questionnaires were not included in our analysis. | score on a scale | MEAN |
| SECONDARY | Comparison of Combined Mean Score on the Karnofsky Performance Status Scale (KPS) by Group | Up to 3 months | Of the intent to treat population, subjects who did not fill out the baseline Karnofsky functional scales were not included in our analysis. They withdrew from the study after signing the consent forms for personal reasons. | score on a scale | MEAN |
| SECONDARY | Comparison of Combined Mean Score on the Pain Questionnaire by Group | Up to 3 months | Of the intent to treat population, subjects who did not fill out the baseline pain questionnaires were not included in our analysis. They withdrew from the study after signing the consent forms for personal reasons. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Comparison of Number of Participants With Grade 1 or 2 Oral Mucositis (GM-CSF and SS Groups Only) | Arm I: GM-CSF Group (GG) | 28 | participants | ||
| Comparison of Number of Participants With Grade 1 or 2 Oral Mucositis (GM-CSF and SS Groups Only) | Arm II: Salt & Soda Group (SS) | 46 | participants | ||
| Comparison of the Mean Number of Days for Mucositis to Heal Across by Group | Arm I: GM-CSF Group (GG) | 81.5 | Standard Deviation 63.43 | days | |
| Comparison of the Mean Number of Days for Mucositis to Heal Across by Group | Arm II: Salt & Soda Group (SS) | 79.4 | Standard Deviation 31.24 | days | |
| Comparison of the Mean Number of Days for Mucositis to Heal Across by Group | Arm III: Salt & Soda Switched to GM-CSF (SG) | 77.4 | Standard Deviation 37.40 | days | |
| Comparison of the Combined Mean Score on the Overall Quality of Life Questionnaires by Group | Arm I: GM-CSF Group (GG) | 6.91 | Standard Deviation 1.59 | score on a scale | |
| Comparison of the Combined Mean Score on the Overall Quality of Life Questionnaires by Group | Arm II: Salt & Soda Group (SS) | 6.80 | Standard Deviation 1.46 | score on a scale | |
| Comparison of the Combined Mean Score on the Overall Quality of Life Questionnaires by Group | Arm III: Salt & Soda Switched to GM-CSF (SG) | 6.77 | Standard Deviation 1.53 | score on a scale | |
| Comparison of Combined Mean Score on the Karnofsky Performance Status Scale (KPS) by Group | Arm I: GM-CSF Group (GG) | 84.52 | Standard Deviation 12.61 | score on a scale | |
| Comparison of Combined Mean Score on the Karnofsky Performance Status Scale (KPS) by Group | Arm II: Salt & Soda Group (SS) | 82.93 | Standard Deviation 10.92 | score on a scale |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm I: GM-CSF Group (GG) | 31 | |
| Overall Study | STARTED | Arm II: Salt & Soda Group (SS) | 29 | |
| Overall Study | STARTED | Arm III: Salt & Soda Switched to GM-CSF (SG) | 31 | |
| Overall Study | COMPLETED | Arm I: GM-CSF Group (GG) | 24 | |
| Overall Study | COMPLETED | Arm II: Salt & Soda Group (SS) | 21 | |
| Overall Study | COMPLETED | Arm III: Salt & Soda Switched to GM-CSF (SG) | 19 | |
| Overall Study | NOT COMPLETED | Arm I: GM-CSF Group (GG) | 7 | |
| Overall Study | NOT COMPLETED | Arm II: Salt & Soda Group (SS) | 8 | |
| Overall Study | NOT COMPLETED | Arm III: Salt & Soda Switched to GM-CSF (SG) | 12 |
Source ClinicalTrials.gov
Adverse events114
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Transfusion | Blood and lymphatic system disorders | Arm I: GM-CSF Group (GG) | 2 | 29 | 2 |
| other | Transfusion | Blood and lymphatic system disorders | Arm II: Salt & Soda Group (SS) | 0 | 28 | 0 |
| other | Transfusion | Blood and lymphatic system disorders | Arm III: Salt & Soda Switched to GM-CSF (SG) | 0 | 28 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Arm I: GM-CSF Group (GG) | 0 | 29 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Arm II: Salt & Soda Group (SS) | 0 | 28 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Arm III: Salt & Soda Switched to GM-CSF (SG) | 1 | 28 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm I: GM-CSF Group (GG) | 1 | 29 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm II: Salt & Soda Group (SS) | 1 | 28 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Arm III: Salt & Soda Switched to GM-CSF (SG) | 1 | 28 | 1 |
| other | Sinus Tachycardia | Cardiac disorders | Arm I: GM-CSF Group (GG) | 1 | 29 | 1 |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I: GM-CSF Group (GG) | 1 | 29 |
| Total, all-cause mortality | Arm II: Salt & Soda Group (SS) | 0 | 28 |
| Total, all-cause mortality | Arm III: Salt & Soda Switched to GM-CSF (SG) | 0 | 28 |
| Total, other adverse events | Arm I: GM-CSF Group (GG) | 18 | 29 |
| Total, other adverse events | Arm II: Salt & Soda Group (SS) | 26 | 28 |
| Total, other adverse events | Arm III: Salt & Soda Switched to GM-CSF (SG) | 27 | 28 |
| Total, serious adverse events | Arm I: GM-CSF Group (GG) | 1 | 29 |
| Total, serious adverse events | Arm II: Salt & Soda Group (SS) | 2 | 28 |
| Total, serious adverse events | Arm III: Salt & Soda Switched to GM-CSF (SG) | 2 | 28 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01CA107080 | Management of Mucositis with GM-CSF | DODD, MARYLIN J | UNIVERSITY OF CALIFORNIA, SAN FRANCISCO | NATIONAL CANCER INSTITUTE | 2003 to 2008 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Arm I: GM-CSF Group (GG) vs Arm II: Salt & Soda Group (SS): Comparison of Number of Participants With Grade 1 or 2 Oral Mucositis (GM-CSF and SS Groups Only) |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00293462
GET https://conductscience.org/api/trials/v1/NCT00293462/events?page=2