A randomised controlled trial of colorectal polyp and cancer prevention using aspirin and resistant starch in carriers of hereditary nonpolyposis colorectal cancer

Not Applicable

Completed

• Conditions: Hereditary non-polyposis colorectal cancer (HNPCC); Cancer; Malignant neoplasm of colon

• Registration Number: ISRCTN59521990
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Trust (UK)

Brief Summary

1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/19073976 2. 2012 aspirin results in http://www.ncbi.nlm.nih.gov/pubmed/22036019 3. 2012 resistant starch results in http://www.ncbi.nlm.nih.gov/pubmed/23140761 4. 2020 results in https://pubmed.ncbi.nlm.nih.gov/32534647/ (added 15/06/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2001-05-18
• Study Completion: 2008-01-31
• Last Update Posted: 29 June 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 861

Inclusion Criteria

A) Genetic diagnosis:
Proven carriers of pathological mutations in mismatch repair genes

B) Clinical diagnosis:
Belong to a recognised Lynch Syndrome family based on the modified Amsterdam criteria (see below) AND have had at least one of the following events:
1. A colorectal cancer
2. An adenoma of over 5 mm diameter
3. A related carcinoma; endometrial carcinoma is particularly predictive of gene carrier status but others include small bowel, uroepithelial, or stomach
4. An adenoma under 40 years of age
5. Two or more adenomas on more than one occasion
6. Also have had an intact colon or have had only a segmental resection and have normal bowel actions

Modified Amsterdam criteria:
1. Three cases of HNPCC related cancer in the family
2. One is a first degree relative of the other two
3. One under 50 years
4. At least two generations affected

All enrolees should also:
1. Be over 25 years old. There is no upper age limit.
2. Have intact colon or have had only a segmental resection and have normal (non-medicated) bowel actions (three or fewer formed bowel actions per day).

Exclusion Criteria

1. Pregnancy (note: there have been few reports of adverse effects associated with aspirin use in pregnancy and aspirin is not regarded as a teratogen so women of child bearing age may be recruited. However, women should temporarily withdraw from the trial if they become pregnant. They can restart immediately after delivery if they are not breast feeding. If mothers are breast feeding they should not re-enter the trial until they have completed breast feeding.)
2. Medical contraindications for aspirin e.g. aspirin induced asthma, previous aspirin/Non-Steroidal Anti-Inflammatory Drug (NSAID) induced peptic ulcer, renal impairment beyond creatinine of 0.15 mmol/l, or haemorrhagic diathesis
3. Already taking NSAIDs or steroids (note: if, during participation in the trial, a participant needs to take a course of NSAIDs they should be temporarily withdrawn from all limbs of the trial)
4. Severe intercurrent disease
5. Known to be Human Immunodeficiency Virus (HIV) positive (routine testing not required)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint will be the number, size and histological stage of colorectal carcinomas found after a minimum of 2 years treatment.