We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
A randomised phase IIb trial to assess the efficacy of ReCharge ice cream in preventing chemotherapy-induced diarrhoea.
- Authors
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.; Sharples, K J
- Abstract
<bold>Purpose: </bold>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.<bold>Methods: </bold>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.<bold>Results: </bold>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.<bold>Conclusions: </bold>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.
- Subjects
PHYSIOLOGICAL effects of chemotherapy; DIARRHEA; ICE cream, ices, etc.; RANDOMIZED controlled trials; TREATMENT effectiveness; LACTOFERRIN; DIARRHEA prevention; ANTIDIARRHEALS; ANTINEOPLASTIC agents; COMPARATIVE studies; DAIRY products; RESEARCH methodology; MEDICAL cooperation; PLACEBOS; QUALITY of life; RESEARCH; SELF-evaluation; TUMORS; EVALUATION research; THERAPEUTICS
- Publication
Supportive Care in Cancer, 2015, Vol 23, Issue 11, p3307
- ISSN
0941-4355
- Publication type
journal article
- DOI
10.1007/s00520-015-2755-0