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
Inclusion Criteria2
- Patient with an early stage cancer suitable for adjuvant chemotherapy or an advanced cancer requiring chemotherapy
- Patients due the first cycle of a chemotherapy regimen (1st, 2nd or 3rd line) with >4 weeks since last regimen *Patient is > 18 years of age *Patient’s therapeutic regimen includes capecitabine, docetaxel, paclitaxel, 5-Fluorouracil (5FU), irinotecan or a combination of agents including one of the above *Patient’s chemotherapy regimen has cycles of 2 or 3 weeks length *Written informed consent *Patient can tolerate ice cream *ECOG (Eastern Cooperative Oncology Group) performance status <3 *Adequate organ function as defined as: Haematological – Haemaglobin > 90g/L, absolute neutrophil count(ANC) >1.5 x 109/L, platelets >100 x109/L; Liver function- bilirubin = 2 x upper limit normal(ULN), aspartate transaminase(AST)/alaninine transaminase (ALT)/ Alkaline phosphatase (ALP) = 2.5 x ULN or = 5 x ULN in presence of liver metastases, albumin= 30 g/L;Renal function- Creatinine clearance > 50 mL/min
Exclusion Criteria3
- Patients with Type I or uncontrolled Type II diabetes. Patients with satisfactory controlled Type II diabetes as defined as a stable haemoglobin A1c (HbA1c) are eligible.
- Patient’s chemo-radiation regimen includes radiation to the abdomen *Past history of intolerance or allergy to cow’s milk, soy or nuts *Patients with diabetes *Patients with a current stoma *Patients diagnosed with coeliac disease *Patients who are taking iron supplements within 7 days of starting study product *Patients with planned granulocyte colony stimulating factor (G-CSF) support
- Patient has participated in another clinical study within the last 4 weeks before inclusion or currently participating in another clinical study involving any non-chemotherapy therapeutic substance which can influence bowel function or the blood count
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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