Adjuvant therapy: colorectal cancer chemotherapy study (LIitännäishoito: Paksu- ja PeräsuoliSYövän SYtostaattiTerapiaTutkimus): comparison of 5-fluorouracil (5-FU) and leucovorin as bolus injection or continuous infusion with special emphasis on toxicity, cost-benefit, quality of life, effect of nu

Background and study aims
Colorectal cancer is the third most common cancer worldwide. Surgery is the mainstay for treatment but adjuvant chemotherapy with 5-fluorouracil in combination with leucovorin has improved survival significantly. Adjuvant treatment is linked to considerable toxicity and thus means for alleviation need to be explored. The mode of chemotherapy administration may improve tolerability, as may nutritional factors such as lactose intolerance and the gut bacterial flora.
Who can participate?
Patients aged between 18-75 years with colorectal cancer, fit for chemotherapy with no significant morbidity.
What does the study involve?
Participants will be randomly allocated to receive 5-fluorouracil and leucovorin either as a single large dose (bolus injection) or by continuous infusion. Participants will also be randomly allocated to receive nutritional counselling with or without supplementation with lactobacillus GG or guar gum fiber. Blood and fecal sampling will be taken before, during and after adjuvant chemotherapy. Patients will be followed up for 10 years.