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Curcumin in Advanced Cervical Cancer

Sponsor
Instituto Nacional de Cancerologia, Columbia (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04294836
Collaborator
(none)
240
Enrollment
2
Arms
25
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Phase II clinical trial, randomized and placebo controlledPhase II clinical trial, randomized and placebo controlled
Masking:
Double (Participant, Investigator)
Masking Description:
double blind masking
Primary Purpose:
Treatment
Official Title:
Randomized Phase II Clinical Trial of Oral Turmeric Supplementation in Patients With Advanced Cervical Cancer
Anticipated Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Compare overall survival and progression free survival [3 yr]

    Global survival

  2. Compare the objective response rate using RECIST radiological criteria [1 yr]

    Objective response by RECIST criteria

  3. Compare the disease control rate [1 yr]

    Disease control rate

Secondary Outcome Measures

  1. Describe the safety of research therapy by classifying Common Terminology Criteria for Adverse Events (CTCAE) [1 yr]

    Common Terminology Criteria for Adverse Events (CTCAE)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Instituto Nacional de Cancerologia, Columbia

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Instituto Nacional de Cancerologia, Columbia
ClinicalTrials.gov Identifier:
NCT04294836
Other Study ID Numbers:
  • IX-023435
First Posted:
Mar 4, 2020
Last Update Posted:
Jun 25, 2021
Last Verified:
Jun 1, 2020
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
Keywords provided by Instituto Nacional de Cancerologia, Columbia
curcumin
natural antioxidant
Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Curcumin

Study Results

No Results Posted as of Jun 25, 2021