Efficacy and safety of trichloroacetic acid vs. electrocautery for the topical treatment of anal intraepithelial neoplasia in HIV-positive patients (TECAIN) – a randomized controlled trial

Not Applicable

• Conditions: anal intraepithelial neoplasia; Z21; Asymptomatic human immunodeficiency virus [HIV] infection status

• Registration Number: DRKS00009692
• Lead Sponsor: niversitätsklinikum Essen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-20
• Study Completion: 2020-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 257

Inclusion Criteria

1. HIV-seropositive
2. Patients of legal competence and age>= 18 years,
3. Sufficient knowledge of the german language, written and spoken,
4. Patient is willing to show up regularly to therpay and follow-up visits,
5. Clinical visible AIN-lesions which are histologically confirmed (result should not be altder than 2 weeks aufter extraction and extraction should not be more than 16 weeks before Baseline),
6. Informed consent.

Exclusion Criteria

1. Currently diagnosed anal cancer or anal cancer in anamnesis ( in the last 5 years),
2. Acute life-threatening disease,
3. Participation in a proctologic study in the last 30 days,
4. Participation in this study prior to this point,
5. Simultaenous participation in a study which excludes the participation in this study,
6. Simultaenous topic therapy and systemic intake of drugs, which influence the study results, e.g. immunmodulating substances: interferons, imiquimod or systemic glucosteroids,
7. Lactation,
8. Pregnancy
9. Women of child-bearing age without sufficient contraception
10. Known intolerance/contraindication against TCA or ECA,
11. Patients, who require a general anaesthesia for therapy at baseline,
12. Other serious intraanal and proktologic diseases, which require additional treatments, which influence the study outcome, e.g. active M. Crohn, which is locally and sytemical treated with Immunesuppressiva, or active STI-Proktitis
13. Patient, who are vaccinated against HPV before studystart.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main question of the TECAIN-study is, if the alternative therapy of anal cancer precursor (AIN) with trichloraceticacid is not inferior to the current standardtherapy with electorcauterisation. For the evaluation of the question the primary outcome is stated as follows: <br>Therapeutic success is defined as clinically (HRA) and histologically confirmed: <br>-resolution of the AIN (or diagnose of Condolyma accuminata), <br>-regression of the AIN (defined as regeression from AINII/III to AIN I) <br>both 4 weeks after the last treatment within TECAIN or after randomization. Patients not showing up at this mandatory follow-up appointment will be counted as treatment failure.

Secondary Outcome Measures

Name	Time	Method
1. Recurrence of AIN at the previously treated sites 6 months after the end of TECAIN treatment and change of anal HPV types.<br>2. Recrudescence of AIN-Lesions and recrudescence number <br>3. HPV multiplicity and viral load 4 weeks and 6 months after the end of TECAIN treatment <br>4. Number of interventions during the 12 weeks initial TECAIN treatment period. <br>5. Duration of the therapy and the amount of the therapy cost <br>6. Documentation of pain and adverse events (AE) during TECAIN treatment as well as use of analgetic drugs (type, dosage, frequency, duration).<br>