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https://hdl.handle.net/2440/103254
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dc.contributor.author | Perez, D. | - |
dc.contributor.author | Sharples, K. | - |
dc.contributor.author | Broom, R. | - |
dc.contributor.author | Jeffery, M. | - |
dc.contributor.author | Proctor, J. | - |
dc.contributor.author | Hinder, V. | - |
dc.contributor.author | Pollard, S. | - |
dc.contributor.author | Edwards, J. | - |
dc.contributor.author | Simpson, A. | - |
dc.contributor.author | Scott, J. | - |
dc.contributor.author | Benge, S. | - |
dc.contributor.author | Krissansen, G. | - |
dc.contributor.author | Geursen, A. | - |
dc.contributor.author | Palmano, K. | - |
dc.contributor.author | MacGibbon, A. | - |
dc.contributor.author | Keefe, D. | - |
dc.contributor.author | Findlay, M. | - |
dc.date.issued | 2015 | - |
dc.identifier.citation | Supportive Care in Cancer, 2015; 23(11):3307-3315 | - |
dc.identifier.issn | 0941-4355 | - |
dc.identifier.issn | 1433-7339 | - |
dc.identifier.uri | http://hdl.handle.net/2440/103254 | - |
dc.description.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. | - |
dc.description.statementofresponsibility | 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 | - |
dc.language.iso | en | - |
dc.publisher | Springer | - |
dc.rights | © Springer-Verlag Berlin Heidelberg 2015 | - |
dc.source.uri | http://dx.doi.org/10.1007/s00520-015-2755-0 | - |
dc.subject | Chemotherapy; diarrhoea; myelosuppression; quality of life; lactoferrin | - |
dc.title | A randomised phase IIb trial to assess the efficacy of ReCharge ice cream in preventing chemotherapy-induced diarrhoea | - |
dc.type | Journal article | - |
dc.identifier.doi | 10.1007/s00520-015-2755-0 | - |
pubs.publication-status | Published | - |
dc.identifier.orcid | Keefe, D. [0000-0001-9377-431X] | - |
Appears in Collections: | Aurora harvest 3 Medicine publications |
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