Cervical Cancer, Stage IIB
Conditions
Keywords
curcumin, natural antioxidant
Brief 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
Detailed 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.
Interventions
DRUGCurcumin
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
DRUGPlacebo oral tablet
PLACEBO Capsules 500mg
Sponsors
Instituto Nacional de Cancerologia, Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
double blind masking
Intervention model description
Phase II clinical trial, randomized and placebo controlled
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare overall survival and progression free survival | 3 yr | Global survival |
| Compare the objective response rate using RECIST radiological criteria | 1 yr | Objective response by RECIST criteria |
| Compare the disease control rate | 1 yr | Disease control rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Describe the safety of research therapy by classifying Common Terminology Criteria for Adverse Events (CTCAE) | 1 yr | Common Terminology Criteria for Adverse Events (CTCAE) |
Outcome results
None listed