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.
Fonterra Co-operative Group Limited
200 participants
Aug 3, 2009
Interventional
Conditions
Summary
ReCharge is a food supplement which contains two milk bioactive components, milk fat and lactoferrin. The purpose of this study is to test the effectiveness of ReCharge in preventing chemotherapy induced diarrhoea (CID). To find out if ReCharge works this study compares ReCharge ice cream (the study product) with an inactive ice cream product (called a placebo). The inactive ice cream looks and tastes just like the ReCharge icecream. Participants will be allocated to one of these two products with equal chances of each product being the one received. Neither the participants nor doctors will know which product participants will be receiving. During the study participants will complete a daily gastrointestinal symptom diary and Quality of Life questionnaire and dietary habits questionnaire at study visits.
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Each patient is expected to ingest a single 100g tub of the investigational product (ReCharge) per day for a total of 8 weeks, starting 2 weeks +/- 4 days before chemotherapy and continuing for the first 6 weeks of chemotherapy. ReCharge icecream is a medical food which contains two milk bioactive components, milk fat and lactoferrin.
Locations(1)
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ACTRN12609000163202