QoL Principal Investigator: Professor Dame Lesley Fallowfield
Lead Researcher: Dr Helena Harder
Data Managers: Shirley May
Funded by: Novartis Pharma AG
This industry-funded, multi-centre international randomised controlled trial, evaluated the efficacy of prophylactic octreotide in the prevention or reduction of diarrhoea in patients with advanced or metastatic breast cancer receiving treatment with lapatinib and capecitabine. The impact of chemotherapy-induced diarrhoea (CID) was investigated from the patient’s perspective by collecting patient-reported outcome data (including a study-specific diarrhoea management diary) before and over the course of the treatment. The trial closed after an interim analysis. The collected patient-reported study outcomes may provide better understanding of the burden of CID, and this data is currently being analysed.