Finding the best dose of aspirin to prevent Lynch Syndrome cancers
| ISRCTN | ISRCTN16261285 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16261285 |
| ClinicalTrials.gov (NCT) | NCT02497820 |
| Clinical Trials Information System (CTIS) | 2014-000411-14 |
| Integrated Research Application System (IRAS) | 141927 |
| Protocol serial number | 17122 |
| Sponsor | Newcastle upon Tyne Hospitals NHS Foundation Trust |
| Funders | Cancer Research UK, Bayer Pharmaceuticals Plc |
- Submission date
- 14/10/2015
- Registration date
- 14/10/2015
- Last edited
- 20/08/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Contact information
Public
Institute of Human Genetics
International Centre For Life
Central Parkway
Newcastle Upon Tyne
NE1 3BZ
United Kingdom
| Phone | +44 191 241 8613 |
|---|---|
| john.burn@ncl.ac.uk |
Scientific
Institute of Human Genetics
International Centre For Life
Central Parkway
Newcastle Upon Tyne
NE1 3BZ
United Kingdom
| CaPP3@ncl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized; Interventional; Design type: Screening, Treatment |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised double blind dose non-inferiority trial of a daily dose of 600 mg versus 300 mg versus 100 mg of enteric-coated aspirin as a cancer preventive in carriers of a germline pathological mismatch repair gene defect, Lynch Syndrome. Project 3 in the Cancer Prevention Programme (CaPP3). |
| Study acronym | CaPP3 |
| Study objectives | The aim of this study is to find the most effective dose of aspirin for people with a mismatch repair gene defect, the underlying cause of Lynch syndrome. |
| Ethics approval(s) | Approved 15/05/2014, NRES Committee North East - Newcastle & North Tyneside 2 (Health Research Authority Ground Floor, Skipton House, 80 London Road, London, SE1 6LH, United Kingdom; no telephone number provided; newcastlenorthtyneside2.rec@hra.nhs.uk), ref: 14/NE/0103 |
| Health condition(s) or problem(s) studied | Lynch syndrome |
| Intervention | Participants are asked to take three tablets each day for 2 years. One tablet will be a placebo, and at least one of the tablets will contain enteric-coated aspirin at a dose of either 100, 300 or 600 mg. After 2 years on the blinded dose, participants will be given 100mg open-label enteric-coated aspirin until the last recruit reaches their fifth anniversary. Drug packs will be delivered directly to the patient to save them from travelling to collect the drug. They will be routinely followed up by an initial phone call at 3 months and then 6-monthly thereafter for the blinded phase. In the open-label phase, only yearly follow-ups will be required. The aim is to balance adequate safety follow-up whilst remaining mindful that patients are not “sick”, so minimising travelling to hospital and being in a clinical environment unnecessarily. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Aspirin |
| Primary outcome measure(s) |
The frequency of Lynch Syndrome Cancers is determined throughout the study and during 10 years following the end of the study. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 15/07/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 3000 |
| Total final enrolment | 1567 |
| Key inclusion criteria | 1. Aged 18 years or over 2. Confirmed germline pathological variant in one of the mismatch repair genes: MSH2, MLH1, PMS2 or MSH6 or a 3’ EPCAM deletion associated with MSH2 silencing or be a carriers of a constitutional epimutation manifesting a classic Lynch syndrome phenotype 3. Able to swallow tablets 4. Willing to complete the CaPP3 consent process as described in the patient information sheet |
| Key exclusion criteria | 1. Regular use of a non-steroidal anti-inflammatory agent (except aspirin*) on a prescription and/or long-term basis. Regular is defined as >3 doses per week 2. Regular use of aspirin (>3 doses per week or on a prescription basis) that cannot be replaced with any one of the randomised arms of the study followed by 100 mg dose 3. Known aspirin intolerance or hypersensitivity, including aspirin-sensitive asthma 4. Existing clinically significant liver impairment 5. Existing renal failure 6. Confirmed active peptic ulcer disease within the previous three months 7. Known bleeding diathesis or concomitant anticoagulant therapy 8. Inability to comply with study procedures and agents 9. Women reporting that they are pregnant or actively planning to achieve a pregnancy within the next two years 10. Women who are breastfeeding 11. Any significant medical illness that would interfere with study participation. (If hypertension is discovered, the participant should be advised to have this treated before commencing trial medication) 12. Participation in the previous CAPP2 study will not exclude patients from this study, apart from the small number recruited less than 10 years previously *Previous use of aspirin for medicinal purposes does not exclude enrollment but duration and quantity need to be documented in detail. |
| Date of first enrolment | 01/10/2014 |
| Date of final enrolment | 31/03/2019 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Central Parkway
Newcastle Upon Tyne
NE1 3BZ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | 20/08/2025 | No | No | ||
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN16261285_Abstract.pdf
- Abstract results
Editorial Notes
20/08/2025: Abstract added.
11/10/2024: The following changes were made to the trial record:
1. The public contact was changed.
2. The scientific contact was added.
3. The IRAS number was added.
4. The overall end date was changed from 31/08/2024 to 15/07/2024.
5. The total final enrolment was added.
08/04/2024: ClinicalTrials.gov number added.
19/08/2021: The following changes were made to the trial record:
1. The overall end date was changed from 31/08/2021 to 31/08/2024.
2. The intention to publish date was added.
04/05/2020: The recruitment end date has been changed from 31/08/2021 to 31/03/2019.
03/04/2019: The condition has been changed from "Topic: Cancer, Genetics; Subtopic: All Cancers/Misc Sites, Genetics Research and Congenital Disorders (all subtopics); Disease: All, Genetics Research and Congenital Disorders" to "Lynch syndrome" following a request from the NIHR.
