|Full title:||A randomised phase IIb, placebo controlled trial to assess the efficacy and safety of ReCharge (a medical food) in preventing chemotherapy induced diarrhoea (CID) when administered daily to patients undergoing chemotherapy.|
|ReCharge is a food supplement which contains two milk bioactive components, milk fat and lactoferrin. Animal studies of chemotherapy-induced diarrhea (CID) suggest that ReCharge has a protective effect on the lining of the intestine. Lactoferrin occurs naturally in milk and contains iron.
The purpose of this study was to test the effectiveness of ReCharge in preventing chemotherapy induced diarrhoea.
To find out if ReCharge works this study compared ReCharge ice cream (the investigational product) with an inactive ice cream product (called a placebo). The inactive ice cream looked and tasted just like the ReCharge icecream. Participants were allocated to one of these two products with equal chances of each product being the one received. Neither the participants nor doctors knew which product participants will be receiving.
Participants were asked to eat a standard tub (100g) of the study ice-cream every day for a total of 8 weeks, starting 2 weeks before chemotherapy and for the first 6 weeks of chemotherapy.
200 patients from across New Zealand were needed for the trial.
· Palmerston North
|Lead Investigator:||Dr David Perez|
|Contact:||Sarah Benge (firstname.lastname@example.org)|
|Trial Registry reference:||ACTRN12609000163202 (click for more details)|
|Publications:||D. Perez, K. 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. A randomised phase IIb trial to assess the efficacy of ReCharge ice-cream in preventing chemotherapy-induced diarrhoea. Support Care Cancer. 2015 Nov; 23(11):3307-15.|