Curcumin in Advanced Cervical Cancer

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Cervical Cancer, Stage IIB

Intervention / Treatment
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* Drug: Curcumin
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Phase II clinical trial, randomized and placebo controlled
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Curcumin<br>Chemotherapy (cisplatin) plus concomitant radiation therapy (teletherapy + high or low rate brachytherapy) + Curcugreen (BCM95) 2000mg daily (each 6h) | Drug: Curcumin<br>* 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<br>|
| Placebo Comparator: Placebo<br>Chemotherapy (cisplatin) plus concomitant radiation therapy (teletherapy + high or low rate brachytherapy) + Placebo Capsules 500mg 2000mg daily (each 6h) | Drug: Placebo oral tablet<br>* PLACEBO Capsules 500mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare overall survival and progression free survival | Global survival | 3 yr | 
| Compare the objective response rate using RECIST radiological criteria | Objective response by RECIST criteria | 1 yr | 
| Compare the disease control rate | Disease control rate | 1 yr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe the safety of research therapy by classifying Common Terminology Criteria for Adverse Events (CTCAE) | Common Terminology Criteria for Adverse Events (CTCAE) | 1 yr | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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curcumin, natural antioxidant