A randomised phase IIb trial to assess the efficacy of ReCharge ice cream in preventing chemotherapy-induced diarrhoea
| Autor: | Michael Findlay, Dorothy M. K. Keefe, S. Benge, Mark Jeffery, Alastair K. H. MacGibbon, A. Geursen, J. Proctor, Reuben James Broom, V. Hinder, S. Pollard, David Perez, J. Edwards, Kay Patricia Palmano, J. Scott, Katrina Sharples, Andrew Simpson, G. Krissansen |
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| Rok vydání: | 2014 |
| Předmět: |
Adult
Diarrhea Male medicine.medical_specialty medicine.medical_treatment Renal function Antineoplastic Agents Placebo Placebos Quality of life Informed consent Internal medicine Neoplasms medicine Humans Adverse effect Antidiarrheals Aged Chemotherapy business.industry Ice Cream Groundwater recharge Middle Aged Chemotherapy regimen Surgery Oncology Quality of Life Female Self Report business |
| Zdroj: | Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 23(11) |
| ISSN: | 1433-7339 |
| Popis: | 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. 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. 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. 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. |
| Databáze: | OpenAIRE |
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