Curcumin in Advanced Cervical Cancer

December 5, 2022 updated by: Instituto Nacional de Cancerologia, Columbia

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare overall survival and progression free survival
Time Frame: 3 yr
Global survival
3 yr
Compare the objective response rate using RECIST radiological criteria
Time Frame: 1 yr
Objective response by RECIST criteria
1 yr
Compare the disease control rate
Time Frame: 1 yr
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)
Time Frame: 1 yr
Common Terminology Criteria for Adverse Events (CTCAE)
1 yr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cancerologia, Columbia

Investigators

  • Principal Investigator: Jose A Carreño, Md, Instituto Nacional de Cancerologia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2021

Primary Completion (Anticipated)

January 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

March 2, 2020

First Submitted That Met QC Criteria

March 2, 2020

First Posted (Actual)

March 4, 2020

Study Record Updates

Last Update Posted (Estimate)

December 7, 2022

Last Update Submitted That Met QC Criteria

December 5, 2022

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IX-023435

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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