{"groups":[{"description":"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.","id":"FG000","title":"Arm I: GM-CSF Group (GG)"},{"description":"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.","id":"FG001","title":"Arm II: Salt & Soda Group (SS)"},{"description":"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.","id":"FG002","title":"Arm III: Salt & Soda Switched to GM-CSF (SG)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"8"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Change Treatment Regimen (ineligible)"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Hypersensitive Reaction (to Salt & Soda)"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Refuse Radiation Treatment"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"No Show"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Went back to his home country"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Blood clot after chemotherapy"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Ischemic stroke after chemotherapy"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Possible Tracheostomy leakage"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Low radiation dose in oral cavity"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Physician Decision"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"31"},{"groupId":"FG001","numSubjects":"29"},{"groupId":"FG002","numSubjects":"31"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"21"},{"groupId":"FG002","numSubjects":"19"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"12"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Of 532 potential subjects that were screened, 374 were excluded as they did not meet the inclusion criteria, 45 refused to participate and 22 were no-shows (declined radiation therapy), thereby reducing our original target sample population to 91.","recruitmentDetails":"Adult (\\> 18 years of age) with confirmed histopathological diagnosis of head and neck carcinoma were recruited at the University of California, San Francisco Radiation Oncology Clinic, the Helen Diller Comprehensive Cancer Center, Saint Francis Medical Center in San Francisco, and Temple University Radiation Oncology Clinic in Philadelphia from May 2005 to Dec 2009."}