title: Randomized double-blind study of the Reliefband as an adjunct to standard antiemetics in patients receiving moderately-high to highly emetogenic chemotherapy.
abstract: OBJECTIVE
  Our goal was to evaluate the efficacy and tolerability of the Reliefband as an adjunct to standard antiemetics in patients receiving moderately-high to highly emetogenic chemotherapy.
  
  
  METHODS
  Forty-nine adult cancer patients receiving moderately-high or highly emetogenic chemotherapy were randomized to receive either the active Reliefband ( n=26) or an inactive device ( n=23). Patients continued to receive all scheduled and as needed antiemetic agents as prescribed. The device was worn the day of chemotherapy administration for 5 days (days 1-5). Patients maintained a daily dairy of nausea severity, vomiting and retching episodes, and antiemetic medications taken. Each patient completed a Functional Living Index Emesis (FLIE) and a tolerability survey at the conclusion of the study. A Wilcoxon rank sum test was used to compare the number of vomiting episodes, severity of nausea and FLIE scores between the two groups.
  
  
  RESULTS
  Patients wearing the active Relifband experienced less vomiting (Reliefband 1.9 versus inactive device 4.6 mean episodes; p=0.05), retching (1.4 versus 3.6 mean episodes; p=0.05), and nausea severity (0.91 versus 1.65 mean cm/day; p=0.01) over the 5-day period compared to patients wearing the inactive device. Vomiting was statistically significantly reduced during the delayed period (0.42 versus 1; p=0.032), whereas nausea was significantly reduced during the acute (0.71 versus 2.3; p=0.028) and delayed (1.8 versus 3.3; p=0.020) periods. FLIE scores did not differ between the two treatment groups (91 versus 80; p=0.088).
  
  
  CONCLUSIONS
  This study suggests that patients receiving moderately-high to highly emetogenic chemotherapy who experience nausea and vomiting despite scheduled antiemetics may benefit from the use of the Reliefband as an adjunct to antiemetics. Limitations of this study include differences in risk factors for emesis, chemotherapy, and antiemetic regimens. A larger, better, controlled randomized study is needed to better define optimal use of this device.
authors.affiliation: University of North Carolina Hospitals, Manning Drive, Chapel Hill, NC 27514, USA.
authors.forename: Imad
authors.initials: I
authors.lastname: Treish
authors.forename: Stacy
authors.initials: S
authors.lastname: Shord
authors.forename: John
authors.initials: J
authors.lastname: Valgus
authors.forename: Donald
authors.initials: D
authors.lastname: Harvey
authors.forename: Jessica
authors.initials: J
authors.lastname: Nagy
authors.forename: Jennifer
authors.initials: J
authors.lastname: Stegal
authors.forename: Celeste
authors.initials: C
authors.lastname: Lindley
mesh_terms: D000328:Adult; D000932:Antiemetics / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D004599:Electric Stimulation Therapy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced* / Q000517:prevention & control*; D009369:Neoplasms / Q000188:drug therapy; D010919:Placebos; D012307:Risk Factors; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced* / Q000517:prevention & control*
chemical_list: D000932:Antiemetics; D010919:Placebos