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Type: Journal article
Title: A randomised phase IIb trial to assess the efficacy of ReCharge ice cream in preventing chemotherapy-induced diarrhoea
Author: 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.
Citation: Supportive Care in Cancer, 2015; 23(11):3307-3315
Publisher: Springer
Issue Date: 2015
ISSN: 0941-4355
Statement of
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
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.
Keywords: Chemotherapy; diarrhoea; myelosuppression; quality of life; lactoferrin
Rights: © Springer-Verlag Berlin Heidelberg 2015
RMID: 0030035039
DOI: 10.1007/s00520-015-2755-0
Appears in Collections:Medicine publications

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