Curcumin in Advanced Cervical Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2023-12-31

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

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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.

Conditions

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Cervical Cancer, Stage IIB

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Phase II clinical trial, randomized and placebo controlled

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

double blind masking

Study Groups

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Curcumin

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

Group Type EXPERIMENTAL

Curcumin

Intervention Type DRUG

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

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

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

PLACEBO Capsules 500mg

Interventions

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Curcumin

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

Intervention Type DRUG

Placebo oral tablet

PLACEBO Capsules 500mg

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No