title: Effect of pH adjustment by mixing steroid for venous pain in colorectal cancer patients receiving oxaliplatin through peripheral vein: a multicenter randomized phase II study (APOLLO).
abstract: OBJECTIVE
  The aim of this phase II clinical trial was to evaluate the preventive effect of dexamethasone mixing injection for venous pain in patients with colorectal cancer during chemotherapy.
  
  
  METHODS
  Patients were randomized to receive a 2-h intravenous infusion of oxaliplatin 130 mg/m(2) on day 1 followed by capecitabine 1000 mg/m(2) (or S-1 40-60 mg/m(2)) twice daily on days 1 through 14 of every 3 weeks with or without dexamethasone 1.65 mg at the infusion on day 1.
  
  
  RESULTS
  A total of 53 patients were enrolled. The analysis population consisted of 49 patients (arm A, with dexamethasone N = 24; arm B, without dexamethasone N = 25). The incidence of venous pain ≥grade 2 based on the CTCAE version 4.0 was 33.3 % in arm A and 56.0 % in arm B (relative risk 0.60; 95 % CI 0.31-1.16). The incidences based on the verbal rating scale for arms A and B were 50.0 and 64.0 %, respectively (relative risk 0.78; 95 % CI 0.48-1.28).
  
  
  CONCLUSIONS
  The primary endpoint was not met in this preliminary study.
authors.affiliation: Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Osaka, Japan.
authors.forename: Taishi
authors.initials: T
authors.lastname: Hata
authors.affiliation: Department of Gastroenterological Surgery, Gastroenterological Center, Cancer Institute Ariake Hospital, Japanese Foundation for Cancer Research, 3-10-6 Ariake, Koto-ku, Tokyo, 135-8550, Japan. michitaka.honda@jfcr.or.jp.
authors.forename: Michitaka
authors.initials: M
authors.lastname: Honda
authors.affiliation: Department of Human Health and Medical Sciences, Kochi Medical School, Kochi, Japan.
authors.forename: Michiya
authors.initials: M
authors.lastname: Kobayashi
authors.affiliation: Department of Surgery, Yodogawa Christian Hospital, Osaka, Japan.
authors.forename: Akihiro
authors.initials: A
authors.lastname: Toyokawa
authors.affiliation: Department of Gastroenterological Oncology, Hyogo Cancer Center, Hyogo, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Tsuda
authors.affiliation: Department of Surgery, Japan Post Kyoto Teishin Hospital, Kyoto, Japan.
authors.forename: Yukihiko
authors.initials: Y
authors.lastname: Tokunaga
authors.affiliation: Department of Surgery, Hyogo Cancer Center, Hyogo, Japan.
authors.forename: Kozo
authors.initials: K
authors.lastname: Takase
authors.affiliation: Department of Surgery, Osaka National Hospital, Osaka, Japan.
authors.forename: Masakazu
authors.initials: M
authors.lastname: Miyake
authors.affiliation: Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morita
authors.affiliation: Kitakyushu General Hospital, Fukuoka, Japan.
authors.forename: Naoki
authors.initials: N
authors.lastname: Nagata
authors.affiliation: Tokai Central Hospital, Gifu, Japan.
authors.forename: Junichi
authors.initials: J
authors.lastname: Sakamoto
authors.affiliation: Advanced Medical Research Center, Aichi Medical University, Aichi, Japan.
authors.forename: Masahiko
authors.initials: M
authors.lastname: Gosho
authors.affiliation: Division of Cancer Center, Aichi Medical University, Aichi, Japan.
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Mishima
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000855:Anorexia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine / Q000008:administration & dosage / Q000009:adverse effects; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007262:Infusions, Intravenous / Q000009:adverse effects; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D000077150:Oxaliplatin; D010146:Pain / Q000209:etiology / Q000517:prevention & control*; D010147:Pain Measurement / Q000379:methods; D011446:Prospective Studies; D012074:Remission Induction; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D000069287:Capecitabine; D003907:Dexamethasone
keywords: Colorectal cancer; Dexamethasone; Oxaliplatin; Venous pain