familial adenomatous polyposis
Conditions
Interventions
aspirin (100 mg/day) + mesalazine (2 g/day), for eight months
aspirin (100 mg/day) + placebo, for eight months
placebo + mesalazine (2 g/day), for eight months
placebo + placebo, for eight months
Sponsors
Kyoto Prefectural University of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Candidate patients have to meet all the following inclusion criteria to participate in the study. # Patients with familial adenomatous polyposis (Participants in the J-FAPP Study III or the J-FAPP Study III-2). # Familial adenomatous polyposis is defined as the presence of more than 100 adenomas in the colorectum including the past. # The patients had been excised their all colorectal polyps more than 5.0 mm in diameter by endoscopy before the trial starts. # The patients who could receive the last endoscopy examination performed 8 months after administration of low-dose aspirin and/or mesalazine.
Exclusion criteria
Exclusion criteria: # Patients currently taking antithrombotics such as Bayaspirin, Panaldine, Warfarin and Persantin etc. # Patients who have undergone colorectal resection (those who have undergone appendectomy are allowed to participate in the study). # Patients with a history of stroke including transient ischemic attack. # 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 inflammatory bowel disease (ulcerative colitis, Crohn syndrome), bleeding diverticulosis, bleeding gastritis. # Patients with bleeding tendency, a platelet count of < 100,000 /mm3, or with abnormal prothrombin time, or white blood cell count of 3,000 /mm3. # Patients with any existing cancer at the time of participation in the trial, excluding radical cure of cancer, thyroid cancer and prostate cancer. # Patients currently taking anticancer drugs. # Patients with known allergy to aspirin or mesalazine. # Women who are or may be pregnant during the study period. # Patients currently taking NSAIDs at least 3 times weekly, for example, as an analgesic. # Patients who took NSAIDs, such as sulindac, for the purpose of cancer chemoprevention but not pass 6 months at the time of the trial start. (Patients taking a lactic acid products such as BIOLACTIS POWDER; are allowed to participate in the trial.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is set as the incidence of recurrence / development of colorectal polyps that more than 5.0 mm in diameter after 8 months oral administration of low-dose aspirin and/or mesalazine. | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum diameter and histology of the colorectal polyps more than 5.0 mm in size after 8 months oral administration of low-dose aspirin and/or mesalazine. The change of all the number of the colorectal polyps smaller than 5.0 mm in diameter are compared between pre and post administration of low-dose aspirin and/or mesalazine. (The changes of polyp number are assessed by at least three medical specialists for colon endoscopy in a blinded manner with several endoscopic photographs in the cecum, the splenic flexure and the lower part of the rectum.) The change of number of the upper gastrointestinal tumor, such as gastric adenoma and duodenal adenoma, are compared between pre and post administration of low-dose aspirin and/or mesalazine. The occurrence of adverse events. The incidence of recurrence /development of colorectal polyps more than 5.0 mm in diameter at 8-12 months after cessation of administration of low-dose aspirin and/or mesalazine. | — |
Countries
Japan
Contacts
Public ContactHideki Ishikawa
Kyoto Prefectural University of Medicine Department of Molecular-Targeting Cancer Prevention
Outcome results
None listed