Please use this identifier to cite or link to this item:
https://hdl.handle.net/2440/103254
Citations | ||
Scopus | Web of Science® | Altmetric |
---|---|---|
?
|
?
|
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 1433-7339 |
Statement of Responsibility: | 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 |
DOI: | 10.1007/s00520-015-2755-0 |
Published version: | http://dx.doi.org/10.1007/s00520-015-2755-0 |
Appears in Collections: | Aurora harvest 3 Medicine publications |
Files in This Item:
There are no files associated with this item.
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.