A randomised phase IIb trial to assess the efficacy of ReCharge ice cream in preventing chemotherapy-induced diarrhoea
Date
2015
Authors
Perez, D.
Sharples, K.
Broom, R.
Jeffery, M.
Proctor, J.
Hinder, V.
Pollard, S.
Edwards, J.
Simpson, A.
Scott, J.
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Journal article
Citation
Supportive Care in Cancer, 2015; 23(11):3307-3315
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D. Perez, K. J. Sharples, R. Broom, M. Jeffery, J. Proctor, V. Hinder, S. Pollard, J. Edwards, A. Simpson, J. Scott, S. Benge, G. Krissansen, A. Geursen, K. Palmano, A. MacGibbon, D. Keefe, M. Findlay
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Abstract
Purpose: 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.
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© Springer-Verlag Berlin Heidelberg 2015