Cervical intraepithelial neoplasia grade II/III with positive margin after surgery
Conditions
Interventions
Trade Name: Thrombo Ass
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Surgery for CIN II/III with positive margins after surgery for CIN II/III with positive margins. 2. Compliant subject 3. Safe contraception Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria Lesion related 1. (Micro)-Invasive Cancer 2. Non-compliance of patient 3. PAP V Drug related 1. Prior history of an adverse gastro-intestinal event (ulcer, hemorrhage) 2. Age > 65 3. Concurrent use of a different NSAID 4. Concurrent use of glucocorticoids 5. Concurrent use of anticoagulants 6. Concurrent use of beta-blocker 7. Concurrent use of lithium 8. Concurrent use of diuretics 9. Concurrent use of cyclosporin 10. Concurrent use of methrotrexat 11. Allergic reaction to sulfonamides 12. Allergic reaction after taking NSAIDs 13. Severe kidney problems with decreased renal function 14. Severe liver problems, hepatic disease 15. Uncontrolled hypertension (> 160/90 mmHg) 16. Asthma 17. Allergic reaction to acetyl salicyl acid 18. Hemorrhagic diathesis 19. Thrombocytopenia 20. Hemophilia Clinical laboratory related Hemoglobin 1.5 x above upper cut-off value Serum GOT > 1.5 x above upper cut-off value Serum GPT > 1.5 x above upper cut-off value Serum alcalic phosphatase > 1.5 x above upper cut-off value Serum creatinine > 1.5 x above cut-off value
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Patients with positive margins after surgery for cervical intraepithelial neoplasia (CIN) II/III are at increased risk for residual/recurrent disease. There is no accepted treatment regimen to reduce the number of recurrent/persistent disease. Various studies showed the efficacy of acetyl salicylic acid as chemopreventive agent and treatment option for cancer and its precursors. With respect to cervical dysplasia cyclooxygenase inhibitors, such as acetyl salicylic acid, were shown to be promising for the treatment of CIN. Acetyl salicylic acid is expected to reduce the rate of recurrent/persistent disease after surgery for CIN II/III with positive margins. Primary outcome parameters: To evaluate whether or not a treatment with acetyl salicylic acid 100mg/day reduces the rate of recurrent/persistent disease after surgery for CIN II/III with positive margins during a 6-month treatment period. ;Secondary Objective: 1. To evaluate safety and side-effects of the applied therapy 2. To determine the effect of this drug on human papillomavirus (HPV) viral load in these patients. ;Primary end point(s): Abnormal PAP smears during the first years after surgery with positive margins after CIN II/III | — |
Countries
Austria
Outcome results
None listed