Curcumin in Advanced Cervical Cancer

Cervical Cancer, Stage IIB Clinical Trial

Official title: Randomized Phase II Clinical Trial of Oral Turmeric Supplementation in Patients With Advanced Cervical Cancer

Status Withdrawn

Clinical Trial Summary

Determine the efficacy and safety of turmeric in the treatment of patients with advanced cervical cancer. Efficacy will be determined through radiological and histopathological criteria through the rate of response to treatment, duration of response, the rate of objective response and disease control, as well as overall survival and disease-free survival. The safety of therapy will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) classification

Clinical Trial Description

A placebo-controlled phase II clinical trial will be developed in patients with advanced cervical cancer who have an indication for radiotherapy. Those who accept to participate will receive the standard treatment with established chemo-radiation and will be randomized in two arms, the experimental will receive 500mg of the commercial presentation (curcugreen) c / 6h VO x 16 weeks and the control arm will receive placebo. The operative hypotheses are: the addition of curcumin to the treatment improves the cumulative probability of 3-year overall survival by 20% and improves the treatment response rate. The statistical analysis will include a Cox proportional hazards model and the results of the groups will be compared with the Student's T-test or ANOVA. This research hopes to collect tissue samples for future research that allows the identification of predictive biomarkers and disease prognoses. ;

Related Conditions & MeSH terms

• Cervical Cancer, Stage IIB
• Uterine Cervical Neoplasms

• NCT number: NCT04294836
• Study type: Interventional
• Source: Instituto Nacional de Cancerologia, Columbia
• Status: Withdrawn
• Phase: Phase 2
• Start date: December 1, 2021
• Completion date: December 31, 2023