Perez, D.Sharples, K.Broom, R.Jeffery, M.Proctor, J.Hinder, V.Pollard, S.Edwards, J.Simpson, A.Scott, J.Benge, S.Krissansen, G.Geursen, A.Palmano, K.MacGibbon, A.Keefe, D.Findlay, M.2017-01-062017-01-062015Supportive Care in Cancer, 2015; 23(11):3307-33150941-43551433-7339http://hdl.handle.net/2440/103254Purpose: 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.en© Springer-Verlag Berlin Heidelberg 2015Chemotherapy; diarrhoea; myelosuppression; quality of life; lactoferrinJournal article003003503910.1007/s00520-015-2755-00003618380000222-s2.0-849425062932-s2.0-84930162941209120Keefe, D. [0000-0001-9377-431X]