Japan colorectal tumor prevention study: randomized controlled trial by low-dose aspiri
- Conditions
- colorectal tumor
- Registration Number
- JPRN-UMIN000000697
- Lead Sponsor
- Basic and clinical researches on the development of chemopreventive drugs
- Brief Summary
Gut. 2014 Jan 31. doi: 10.1136/gutjnl-2013-305827. [Epub ahead of print] The preventive effects of low-dose enteric-coated aspirin tablets on the development of colorectal tumours in Asian patients: a randomised trial. Ishikawa H1, Mutoh M, Suzuki S, Tokudome S, Saida Y, Abe T, Okamura S, Tajika M, Joh T, Tanaka S, Kudo SE, Matsuda T, Iimuro M, Yukawa T, Takayama T, Sato Y, Lee K, Kitamura S, Mizuno M, Sano Y, Gondo N, Sugimoto K, Kusunoki M, Goto C, Matsuura N, Sakai T, Wakabayashi K. OBJECTIVE: To evaluate the influence of low-dose, enteric-coated aspirin tablets (100 mg/day for 2 years) on colorectal tumour recurrence in Asian patients with single/multiple colorectal tumours excised by endoscopy. DESIGN: A double-blinded, randomised, placebo-controlled multicentre clinical trial was conducted. PARTICIPANTS: 311 subjects with single/multiple colorectal adenomas and adenocarcinomas excised by endoscopy were enrolled in the study (152 patients in the aspirin group and 159 patients in the placebo group). Enrolment began at the hospitals (n=19) in 2007 and was completed in 2009. RESULTS: The subjects treated with aspirin displayed reduced colorectal tumourigenesis and primary endpoints with an adjusted OR of 0.60 (95% CI 0.36 to 0.98) compared with the subjects in the placebo group. Subgroup analysis revealed that subjects who were non-smokers, defined as those who had smoked in the past or who had never smoked, had a marked reduction in the number of recurrent tumours in the aspirin-treated group. The adjusted OR for aspirin treatment in non-smokers was 0.37 (CI 0.21 to 0.68, p<0.05). Interestingly, the use of aspirin in smokers resulted in an increased risk, with an OR of 3.44. In addition, no severe adverse effects were observed in either group. CONCLUSIONS: Low-dose, enteric-coated aspirin tablets reduced colorectal tumour recurrence in an Asian population. The results are consistent with those obtained from other randomised controlled trials in Western countries.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 700
Not provided
# Patients with a medical history of submucosal or deeper colorectal cancer. # Patients currently taking antithrombotics such as Bayaspirin, Bufferin, Panaldine, Warfarin and Persantin. # Patients who have undergone colorectal resection (those who have undergone appendectomy are allowed to participate in the study). # Patients with familial colorectal adenoma. # Patients with a history of treatment of gastric or duodenal ulcer (those with successful eradication of Helicobacter pylori and ulcer resolution at S2 are allowed to participate in the study) # Patients with bleeding tendency, a platelet count of 150,000, or with abnormal PT # Patients with any existing cancer at the time of participation in the study. # Patients with known allergy to aspirin. # Patients currently taking anticancer drugs. # Women who are or may be pregnant during the study period. # Patients currently taking NSAIDs at least 3 times weekly, for example, as a analgesic.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Only the occurrence of a colorectal tumor (adenoma or cancer) is selected as the primary endpoint.
- Secondary Outcome Measures
Name Time Method