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Curcumin in Advanced Cervical Cancer

Primary Purpose

Cervical Cancer, Stage IIB

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Curcumin
Placebo oral tablet
Sponsored by
Instituto Nacional de Cancerologia, Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer, Stage IIB focused on measuring curcumin, natural antioxidant

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Curcumin

    Placebo

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Compare overall survival and progression free survival
    Global survival
    Compare the objective response rate using RECIST radiological criteria
    Objective response by RECIST criteria
    Compare the disease control rate
    Disease control rate

    Secondary Outcome Measures

    Describe the safety of research therapy by classifying Common Terminology Criteria for Adverse Events (CTCAE)
    Common Terminology Criteria for Adverse Events (CTCAE)

    Full Information

    First Posted
    March 2, 2020
    Last Updated
    December 5, 2022
    Sponsor
    Instituto Nacional de Cancerologia, Columbia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04294836
    Brief Title
    Curcumin in Advanced Cervical Cancer
    Official Title
    Randomized Phase II Clinical Trial of Oral Turmeric Supplementation in Patients With Advanced Cervical Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Issues with local regulatory authority
    Study Start Date
    December 1, 2021 (Anticipated)
    Primary Completion Date
    January 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Instituto Nacional de Cancerologia, Columbia

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. 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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Cancer, Stage IIB
    Keywords
    curcumin, natural antioxidant

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    Phase II clinical trial, randomized and placebo controlled
    Masking
    ParticipantInvestigator
    Masking Description
    double blind masking
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Curcumin
    Arm Type
    Experimental
    Arm Description
    Chemotherapy (cisplatin) plus concomitant radiation therapy (teletherapy + high or low rate brachytherapy) + Curcugreen (BCM95) 2000mg daily (each 6h)
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Chemotherapy (cisplatin) plus concomitant radiation therapy (teletherapy + high or low rate brachytherapy) + Placebo Capsules 500mg 2000mg daily (each 6h)
    Intervention Type
    Drug
    Intervention Name(s)
    Curcumin
    Intervention Description
    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
    Intervention Name(s)
    Placebo oral tablet
    Intervention Description
    PLACEBO Capsules 500mg
    Primary Outcome Measure Information:
    Title
    Compare overall survival and progression free survival
    Description
    Global survival
    Time Frame
    3 yr
    Title
    Compare the objective response rate using RECIST radiological criteria
    Description
    Objective response by RECIST criteria
    Time Frame
    1 yr
    Title
    Compare the disease control rate
    Description
    Disease control rate
    Time Frame
    1 yr
    Secondary Outcome Measure Information:
    Title
    Describe the safety of research therapy by classifying Common Terminology Criteria for Adverse Events (CTCAE)
    Description
    Common Terminology Criteria for Adverse Events (CTCAE)
    Time Frame
    1 yr

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jose A Carreño, Md
    Organizational Affiliation
    Instituto Nacional de Cancerología
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30427093
    Citation
    Saadipoor A, Razzaghdoust A, Simforoosh N, Mahdavi A, Bakhshandeh M, Moghadam M, Abdollahi H, Mofid B. Randomized, double-blind, placebo-controlled phase II trial of nanocurcumin in prostate cancer patients undergoing radiotherapy. Phytother Res. 2019 Feb;33(2):370-378. doi: 10.1002/ptr.6230. Epub 2018 Nov 14.
    Results Reference
    result
    PubMed Identifier
    18252805
    Citation
    Javvadi P, Segan AT, Tuttle SW, Koumenis C. The chemopreventive agent curcumin is a potent radiosensitizer of human cervical tumor cells via increased reactive oxygen species production and overactivation of the mitogen-activated protein kinase pathway. Mol Pharmacol. 2008 May;73(5):1491-501. doi: 10.1124/mol.107.043554. Epub 2008 Feb 5.
    Results Reference
    result
    PubMed Identifier
    20160040
    Citation
    Javvadi P, Hertan L, Kosoff R, Datta T, Kolev J, Mick R, Tuttle SW, Koumenis C. Thioredoxin reductase-1 mediates curcumin-induced radiosensitization of squamous carcinoma cells. Cancer Res. 2010 Mar 1;70(5):1941-50. doi: 10.1158/0008-5472.CAN-09-3025. Epub 2010 Feb 16.
    Results Reference
    result
    PubMed Identifier
    26771294
    Citation
    Hejazi J, Rastmanesh R, Taleban FA, Molana SH, Hejazi E, Ehtejab G, Hara N. Effect of Curcumin Supplementation During Radiotherapy on Oxidative Status of Patients with Prostate Cancer: A Double Blinded, Randomized, Placebo-Controlled Study. Nutr Cancer. 2016;68(1):77-85. doi: 10.1080/01635581.2016.1115527. Epub 2016 Jan 15.
    Results Reference
    result
    PubMed Identifier
    21532153
    Citation
    Sasaki H, Sunagawa Y, Takahashi K, Imaizumi A, Fukuda H, Hashimoto T, Wada H, Katanasaka Y, Kakeya H, Fujita M, Hasegawa K, Morimoto T. Innovative preparation of curcumin for improved oral bioavailability. Biol Pharm Bull. 2011;34(5):660-5. doi: 10.1248/bpb.34.660.
    Results Reference
    result
    PubMed Identifier
    26837852
    Citation
    Zaman MS, Chauhan N, Yallapu MM, Gara RK, Maher DM, Kumari S, Sikander M, Khan S, Zafar N, Jaggi M, Chauhan SC. Curcumin Nanoformulation for Cervical Cancer Treatment. Sci Rep. 2016 Feb 3;6:20051. doi: 10.1038/srep20051.
    Results Reference
    result
    PubMed Identifier
    18628464
    Citation
    Dhillon N, Aggarwal BB, Newman RA, Wolff RA, Kunnumakkara AB, Abbruzzese JL, Ng CS, Badmaev V, Kurzrock R. Phase II trial of curcumin in patients with advanced pancreatic cancer. Clin Cancer Res. 2008 Jul 15;14(14):4491-9. doi: 10.1158/1078-0432.CCR-08-0024.
    Results Reference
    result

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    Curcumin in Advanced Cervical Cancer

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