Curcumin in Advanced Cervical Cancer

Instituto Nacional de Cancerologia, Columbia

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Cervical Cancer, Stage IIB

Interventions

CurcuminDRUG

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 tabletDRUG

PLACEBO Capsules 500mg

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: Women aged 18 years or older * Voluntary acceptance of participation and signing of informed consent * Radiotherapy indication * Histological confirmation of squamous cervical cancer or histologically confirmed adenocarcinoma * Stage IIB - VAT * Chemo-radiation indication with Cisplatin, Cisplatin/fluorouracil, Carboplatin (if cisplatin intolerant) * ECOG equal to or less than 1 and a Karnofsky index equal to or greater than 70%. Exclusion Criteria: * Being pregnant or breastfeeding * Presence of second concomitant neoplasia * Any previous surgical, radiotherapy or chemotherapy treatment. * Diagnosis of invasive recurrent carcinoma of the cervix * Receive anticoagulant therapy * Receive immunosuppression therapy * Presence of coagulation disorders, such as platelet count less than 100,000 at the time of the joint evaluation, absolute neutrophil count less than 1,500 / ml * Presence of signs of systemic infection * Renal failure, creatinine clearance less than 45 ml/min confirmed with glomerular filtration less than 45 ml / min; evidence of unilateral renal exclusion * Patients with uncontrolled metabolic disease

Outcomes

Primary Outcomes

Compare overall survival and progression free survival

Global survival

Time frame: 3 yr

Compare the objective response rate using RECIST radiological criteria

Objective response by RECIST criteria

Time frame: 1 yr

Compare the disease control rate

Disease control rate

Time frame: 1 yr

Secondary Outcomes

Describe the safety of research therapy by classifying Common Terminology Criteria for Adverse Events (CTCAE)

Common Terminology Criteria for Adverse Events (CTCAE)

Time frame: 1 yr

Data from ClinicalTrials.gov

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