{"groups":[{"description":"All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site.\n\nStandard Oral Hygiene: Oral hygiene care provided per individual institutions standard of care.","id":"FG000","title":"Standard Oral Hygiene"},{"description":"All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site.\n\nThe True acupuncture points will be at 3 sites on each ear, a site on the chin, on each forearm, a site on each hand, a site on each leg, and one placebo needle for a total of 14 sites. All sites will be applied for 20 minutes.\n\nStandard Oral Hygiene + True Acupuncture: Oral hygiene care provided per individual institutions standard of care.\n\n14 true acupoint sites will be selected and applied to each participant for 20 minutes at each session. There will be 2 sessions a week for 8 weeks.","id":"FG001","title":"Standard Oral Hygiene + True Acupuncture"},{"description":"All patients will receive standard oral hygiene patient teaching information that includes instructions regarding mouth rinses, use of lip balms, use of mild fluoride toothpaste, the importance of adequate oral hydration, and other standard advice. Each participating site determines the standard oral hygiene recommendations used at their site.\n\nThe Sham acupuncture points will be given according to the same schedule as the active acupuncture points, except the Sham needles will be placed below, above or between true active points.\n\nStandard Oral Hygiene + Sham Acupuncture: Oral hygiene care provided per individual institutions standard of care.\n\n14 sham acupoint sites will be selected and applied to each participant for 20 minutes at each session. There will be 2 sessions a week for 8 weeks.","id":"FG002","title":"Standard Oral Hygiene + Sham Acupuncture"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"6"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"3"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"3"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"4"}],"type":"Other: includes Patient found to be ineligible, distance, no benefit, lost insurance"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"86"},{"groupId":"FG001","numSubjects":"86"},{"groupId":"FG002","numSubjects":"86"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"62"},{"groupId":"FG001","numSubjects":"73"},{"groupId":"FG002","numSubjects":"69"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"13"},{"groupId":"FG002","numSubjects":"17"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"258 of 281 eligible screened participants enrolled and randomized into study. Reasons for the 23 which chose not to participate: 16 no reason given 5 Too busy\n\n1 did not want randomization\n\n1 distance.","recruitmentDetails":"Study was designed with first enrollment July 29,2013 under the oversight of MD Anderson (MDA) Community Clinical Oncology Program (CCOP) Research Base (RB) (NCI Division of Cancer Prevention (DCP) #MDA 04-01; MDA Protocol #2010-0547). Twenty-eight participants recruited from multiple centers. After the MDA CCOP RB was closed, the trial transferred to Wake Forest (WF) NCI Community Oncology Research Program (NCORP) RB (2UG1CA189824) where the trial continued (WF-97115) from April 2016-June 2021."}