50102
document
A randomized placebo-controlled prevention trial of aspirin and/or resistant starch in young people with familial adenomatous polyposis . Evidence supporting aspirin and resistant starch ( RS ) for colorectal cancer prevention comes from epidemiologic and laboratory studies ( aspirin and RS ) and randomized controlled clinical trials ( aspirin ) . Familial adenomatous polyposis ( FAP ) strikes young people and , untreated , confers virtually a 100 % risk of colorectal cancer and early death . We conducted an international , multicenter , randomized , placebo-controlled trial of aspirin ( 600 mg/d ) and/or RS ( 30 g/d ) for from 1 to 12 years to prevent disease progression in FAP patients from 10 to 21 years of age . In a 2 × 2 factorial design , patients were randomly assigned to the following four study arms : aspirin plus RS placebo ; RS plus aspirin placebo ; aspirin plus RS ; RS placebo plus aspirin placebo ; they were followed with standard annual clinical examinations including endoscopy . The primary endpoint was polyp number in the rectum and sigmoid colon ( at the end of intervention ) , and the major secondary endpoint was size of the largest polyp . A total of 206 randomized FAP patients commenced intervention , of whom 133 had at least one follow-up endoscopy and were therefore included in the primary analysis . Neither intervention significantly reduced polyp count in the rectum and sigmoid colon : aspirin relative risk = 0.77 ( 95 % CI , 0.54-1.10 ; versus nonaspirin arms ) ; RS relative risk = 1.05 ( 95 % CI , 0.73-1.49 ; versus non-RS arms ) . There was a trend toward a smaller size of largest polyp in patients treated with aspirin versus nonaspirin -- mean 3.8 mm versus 5.5 mm for patients treated 1 or more years ( adjusted P = 0.09 ) and mean 3.0 mm versus 6.0 mm for patients treated more than 1 year ( P = 0.02 ) ; there were similar weaker trends with RS versus non-RS . Exploratory translational endpoints included crypt length ( which was significantly shorter in normal-appearing mucosa in the RS group over time ) and laboratory measures of proliferation ( including Ki67 ) . This clinical trial is the largest ever conducted in the setting of FAP and found a trend of reduced polyp load ( number and size ) with 600 mg of aspirin daily . RS had no clinical effect on adenomas .
50103
Intervention_Control
placebo-controlled
50104
Intervention_Pharmacological
aspirin
50105
Intervention_Pharmacological
resistant starch
50106
Intervention_Pharmacological
aspirin
50107
Intervention_Pharmacological
resistant starch ( RS )
50108
Intervention_Pharmacological
aspirin
50109
Intervention_Pharmacological
RS
50110
Intervention_Pharmacological
aspirin
50111
Intervention_Control
placebo-controlled
50112
Intervention_Pharmacological
aspirin
50113
Intervention_Pharmacological
RS
50114
Participant_Age
young
50115
Participant_Condition
familial adenomatous polyposis
50116
Participant_Condition
colorectal cancer
50117
Participant_Age
10 to 21 years