title: A randomised phase IIb trial to assess the efficacy of ReCharge ice cream in preventing chemotherapy-induced diarrhoea.
abstract: OBJECTIVE
  Chemotherapy-induced diarrhoea (CID) has a significant impact. A medicinal food product (ReCharge) containing iron-saturated lactoferrin and anhydrous milk fat reduces the detrimental effects of chemotherapy on the gut in animals. We report results of a randomised blinded placebo-controlled phase IIb trial investigating the efficacy and safety of ReCharge in preventing CID.
  
  
  METHODS
  Eligible patients were adults due to start the first cycle of a 2- or 3-week-cycle chemotherapy regimen, had an Eastern Cooperative Oncology Group (ECOG) status of 3 or less, had adequate haematological, liver and renal function and provided written informed consent. Patients (197) were randomised to ReCharge or placebo. They consumed 100-g study product for 2 weeks before and 6 weeks after starting chemotherapy, completed daily diaries for 8 weeks and attended clinic visits until 12 weeks (2-week cycles) or 14 weeks (3-week cycles). The primary outcome was days with CID.
  
  
  RESULTS
  The mean number of days with diary-recorded CID was marginally but not statistically significantly lower on ReCharge than placebo (-2.0, 95 % CI (-4.7 to 0.7), p = 0.2). The proportion reporting diarrhoea in the previous cycle at the clinic visit was 30 % lower (p = 0.012) on ReCharge. Missing diary data may have contributed to the discrepancy. No significant differences were found in quality of life or other adverse events.
  
  
  CONCLUSIONS
  We found no clear evidence that ReCharge reduced CID as measured by patient self-report diary. The converse finding of benefit as recorded at clinic visits and incomplete adherence to diary completion indicates that further research is required into methods for measuring CID.
authors.affiliation: University of Otago Medical School, Dunedin, New Zealand. david.perez@southerndhb.govt.nz.|Department of Oncology, Dunedin Hospital, Private Bag 1921, Dunedin, 9054, New Zealand. david.perez@southerndhb.govt.nz.
authors.forename: D
authors.initials: D
authors.lastname: Perez
authors.affiliation: Department of Preventive and Social Medicine, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.|Cancer Trials New Zealand, University of Auckland Faculty of Medical & Health Sciences, Auckland, New Zealand.
authors.forename: K J
authors.initials: KJ
authors.lastname: Sharples
authors.affiliation: Auckland Regional Cancer & Blood Service, Auckland District Health Board, Auckland, New Zealand.
authors.forename: R
authors.initials: R
authors.lastname: Broom
authors.affiliation: Medical Oncology, Canterbury District Health Board, Christchurch, New Zealand.
authors.forename: M
authors.initials: M
authors.lastname: Jeffery
authors.affiliation: Cancer Trials New Zealand, University of Auckland Faculty of Medical & Health Sciences, Auckland, New Zealand.
authors.forename: J
authors.initials: J
authors.lastname: Proctor
authors.affiliation: Cancer Trials New Zealand, University of Auckland Faculty of Medical & Health Sciences, Auckland, New Zealand.
authors.forename: V
authors.initials: V
authors.lastname: Hinder
authors.affiliation: Cancer Trials New Zealand, University of Auckland Faculty of Medical & Health Sciences, Auckland, New Zealand.
authors.forename: S
authors.initials: S
authors.lastname: Pollard
authors.affiliation: Wellington Blood & Cancer Centre, Capital & Coast District Health Board, Kilbirnie, New Zealand.
authors.forename: J
authors.initials: J
authors.lastname: Edwards
authors.affiliation: Wellington Blood & Cancer Centre, Capital & Coast District Health Board, Kilbirnie, New Zealand.
authors.forename: A
authors.initials: A
authors.lastname: Simpson
authors.affiliation: Cancer Trials New Zealand, University of Auckland Faculty of Medical & Health Sciences, Auckland, New Zealand.
authors.forename: J
authors.initials: J
authors.lastname: Scott
authors.affiliation: Cancer Trials New Zealand, University of Auckland Faculty of Medical & Health Sciences, Auckland, New Zealand.
authors.forename: S
authors.initials: S
authors.lastname: Benge
authors.affiliation: Cancer Trials New Zealand, University of Auckland Faculty of Medical & Health Sciences, Auckland, New Zealand.
authors.forename: G
authors.initials: G
authors.lastname: Krissansen
authors.affiliation: LactoPharma NZ LTD-Fonterra Co-operative Group Ltd., Hamilton, New Zealand.
authors.forename: A
authors.initials: A
authors.lastname: Geursen
authors.affiliation: LactoPharma NZ LTD-Fonterra Co-operative Group Ltd., Hamilton, New Zealand.
authors.forename: K
authors.initials: K
authors.lastname: Palmano
authors.affiliation: LactoPharma NZ LTD-Fonterra Co-operative Group Ltd., Hamilton, New Zealand.
authors.forename: A
authors.initials: A
authors.lastname: MacGibbon
authors.affiliation: University of Adelaide, Adelaide, Australia.
authors.forename: D
authors.initials: D
authors.lastname: Keefe
authors.affiliation: Cancer Trials New Zealand, University of Auckland Faculty of Medical & Health Sciences, Auckland, New Zealand.
authors.forename: M
authors.initials: M
authors.lastname: Findlay
mesh_terms: D000328:Adult; D000368:Aged; D000930:Antidiarrheals / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D003967:Diarrhea / Q000139:chemically induced* / Q000188:drug therapy / Q000517:prevention & control*; D005260:Female; D006801:Humans; D007054:Ice Cream; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy; D010919:Placebos; D011788:Quality of Life; D057566:Self Report
chemical_list: D000930:Antidiarrheals; D000970:Antineoplastic Agents; D010919:Placebos
keywords: Chemotherapy; Diarrhoea; Lactoferrin; Myelosuppression; Quality of life