{"database":"ecrin-mdr-crc","file_versions":[],"scores":null,"additional":{"omics_type":["Clinical"],"study_start_year":["2014"],"condition":["Systemic Inflammation","Colorectal cancer","Cancer-Bowel-Back passage (rectum) or large bowel (colon)","Inflammatory and Immune System-Other inflammatory or immune system disorders"],"disease":["Inflammatory And Immune System-other Inflammatory Or Immune System Disorders","Systemic Inflammation","Colorectal Cancer","Cancer-bowel-back Passage (rectum) Or Large Bowel (colon)"],"study_type":["Interventional"],"full_dataset_link":["https://newmdr.ecrin.org/Study/2460502"],"location":["Australia"],"study_start_month":["4"],"repository":["ECRIN MDR"],"study_status":["Not yet recruiting"],"additional_accession":[]},"is_claimable":false,"name":"The STRICT pilot study - Simvastatin Therapy for Reducing Inflammation in Colorectal cancer Trial","description":"Interventions: Participants will receive standard first line chemotherapy, as chosen by their treating medical oncologist. In addition, participants will be asked to take a daily 40mg dose of simvastatin orally in the evening from the first day of chemotherapy until tumour progression or patient is withdrawn from treatment due to clinician or patient decision. \nAdherence to medication will be conducted using patient diaries, completion of a monthly Medication Adherence Record Scale-5 questionnaire, and pharmacy records.\nPrimary outcome(s): Toxicity: Incidence of serious Grade 3 or 4 toxicity graded according to NCI CTCAE version 4.03[until tumour progression (anticipated to be <12 months)]\nStudy Design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy","dates":{"creation":"2014-04-15"},"accession":"2460502","cross_references":{"Australian New Zealand Clinical Trials Registry":["ACTRN12614000133639"]}}