A randomised phase IIb trial to assess the efficacy of ReCharge ice cream in preventing chemotherapy-induced diarrhoea

• Published in: Supportive care in cancer 2015-11, Vol.23 (11), p.3307-3315
• Main Authors: Perez, D., Sharples, K. J., 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.
• Format: Article
• Language: English
• Subjects: Adult; Aged; Antidiarrheals - therapeutic use; Antineoplastic Agents - adverse effects; Antineoplastic Agents - therapeutic use; Chemotherapy; Clinical trials; Diarrhea; Diarrhea - chemically induced; Diarrhea - drug therapy; Diarrhea - prevention & control; Female; Humans; Ice Cream; Lactoferrin; Liver; Male; Medicine; Medicine & Public Health; Middle Aged; Neoplasms - drug therapy; Nursing; Nursing Research; Oncology; Original Article; Pain Medicine; Placebos; Quality of Life; Rehabilitation Medicine; Self Report; Side effects
• ISSN: 0941-4355; 1433-7339
• DOI: 10.1007/s00520-015-2755-0

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.