Curcumin in Advanced Cervical Cancer

Instituto Nacional de Cancerologia, Columbia

Status and phase: Withdrawn; Phase 2

Conditions: Cervical Cancer, Stage IIB

Treatments: Drug: Placebo oral tablet; Drug: Curcumin

Study type: Interventional

Funder types: Other

Identifiers

NCT04294836

IX-023435

Details and patient eligibility

About

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

Full 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.

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

0 participants in 2 patient groups, including a placebo group

Curcumin

Experimental group

Description:

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

Treatment:

Drug: Curcumin

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo oral tablet