BACR 2: Assessing the feasibility of conducting a primary chemoprevention study of curcumin in young patients with FAP
1University of Leicester, Leicester, UK
FAP is an autosomal dominant condition caused by a germ-line mutation in the APC gene. Colonic adenomas develop during the mid-teenage years and almost all patients will develop colorectal cancer if they are not managed at an early stage. The safest preventive strategy is surgical resection of the colon when polyposis develops.
There is a paucity of trials investigating the use of primary chemoprevention to delay polyp formation in paediatric FAP. There are extensive pre- and early clinical data demonstrating that curcumin may be a safe and effective chemotherapeutic agent at reducing the polyp burden in this disease. We considered that a clinical study to assess whether curcumin treatment delays the need for surgery and/or prevents cancer in young patients diagnosed with FAP may be both acceptable and beneficial to this population.
A questionnaire study of patients and parents of children affected by FAP was conducted
The response rate was 25%. 33 adults and 6 children completed the survey. Over 80% stated that primary chemoprevention to delay surgery in FAP would be beneficial. A history of current or previous chemopreventive agent use was reported in >50% of respondents. Twelve patients (31%) had taken curcumin, 80% of whom would recommend its use to young FAP patients.
The inclusion of a placebo in trial design was controversial with 83% of young patients stating that they would partake if they were guaranteed to receive curcumin whereas only 50% would partake if there was a placebo arm.
The poor response rate indicates that inadequate recruitment as that observed in previous FAP primary chemoprevention studies is likely but there are some patients for whom this study is relevant and desirable. Those with personal history of curcumin use reported that it was tolerable and would recommend it to others