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Female Urogenital Diseases and Pregnancy Complications

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Turmeric extract

Cisplatin

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Turmeric

Chemotherapy (cisplatin) plus concomitant radiation therapy (teletherapy + high or low rate brachytherapy) + Curcugreen (BCM95) 2000mg daily (each 6h)

Chemotherapy (cisplatin) plus concomitant radiation therapy (teletherapy + high or low rate brachytherapy) + Placebo Capsules 500mg 2000mg daily (each 6h)

BCM-95® (CURCUGREEN®) is a 100 percent pure extract of turmeric with enhanced bio-availability and bio-efficacy. Its powerful health-promoting benefits are derived from the colorful and aromatic qualities of the Indian spice

Placebo oral tablet

Jose A Carreño, Md

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

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.

Phase II clinical trial, randomized and placebo controlled

Curcumin in Advanced Cervical Cancer

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

Common Terminology Criteria for Adverse Events (CTCAE)

Instituto Nacional de Cancerologia, Columbia

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Curcumin in Advanced Cervical Cancer	NCT04294836	Cervical Cancer...	Curcumin Placebo oral ta...	18 Years - 70 Years	Instituto Nacional de Cancerologia, Columbia
Curcumin in Advanced Cervical Cancer	NCT04294836	Cervical Cancer...	Curcumin Placebo oral ta...	18 Years - 70 Years	Instituto Nacional de Cancerologia, Columbia

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