Status:
UNKNOWN
Prebiotics and Probiotics During Definitive Treatment With Chemotherapy-radiotherapy SCC of the Anal Canal (BISQUIT)
Lead Sponsor:
AC Camargo Cancer Center
Conditions:
Anal Cancer Squamous Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Phase II randomized study of the use of pre-and probiotics during the definitive treatment of chemotherapy-radiotherapy (Ch-RT) for patients with localized anal canal squamous cell cancer (ACSCC) with...
Detailed Description
Although anal canal squamous cell carcinoma (ACSCC) is rare in developed countries, it has shown an annual increase of 4% in its incidence in Brazil, and according to data from the Oncocenter Foundati...
Eligibility Criteria
Inclusion
- Patients older than 18 years;
- Confirmed histological diagnosis of squamous cell carcinoma / squamous cell carcinoma of the anal canal (ACSCC);
- Patients with localized ACSCC (≥ T2N0M0, according to American Joint Committee on Cancer (AJCC) 8th edition) staged by conventional imaging methods according to institutional routine;
- Indication of starting definitive treatment with Ch-RT in the institution. HIV-positive patients may be included;
- Free and informed consent signed by the patient or legal representative
Exclusion
- Diagnosis of perianal squamous cell carcinomas;
- Clinical condition leading to difficulty in swallowing;
- Patients with a contraindication to receiving Ch-RT, ie receiving only radiotherapy or not receiving polychemotherapy;
- Clinical condition that, due to the investigator's judgment, prevents adherence to the study
- Active infection requiring antibiotic therapy
Key Trial Info
Start Date :
March 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 11 2024
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT03870607
Start Date
March 13 2019
End Date
February 11 2024
Last Update
January 17 2023
Active Locations (1)
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1
AC Camargo Cancer Center
São Paulo, São Paulo, Brazil, 01525000