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 Limited0 个研究点目标入组 200 人开始时间: 2009年4月3日最近更新: 2020年1月13日

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•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

•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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