NCT04294836

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2021

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2020

Completed
1.7 years until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

December 7, 2022

Status Verified

June 1, 2020

Enrollment Period

1.2 years

First QC Date

March 2, 2020

Last Update Submit

December 5, 2022

Conditions

Cervical Cancer, Stage IIB

Keywords

curcuminnatural antioxidant

Outcome Measures

Primary Outcomes (3)

  • Compare overall survival and progression free survival

    Global survival

    3 yr

  • Compare the objective response rate using RECIST radiological criteria

    Objective response by RECIST criteria

    1 yr

  • Compare the disease control rate

    Disease control rate

    1 yr

Secondary Outcomes (1)

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

    1 yr

Study Arms (2)

Curcumin

EXPERIMENTAL

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

Drug: Curcumin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo oral tablet

Interventions

CurcuminDRUG

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

Curcumin
Placebo oral tabletDRUG

PLACEBO Capsules 500mg

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%.

You may not qualify if:

  • 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
  • Patients with uncontrolled metabolic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 30427093RESULT

  • 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.

    PMID: 18252805RESULT

  • 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.

    PMID: 20160040RESULT

  • 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.

    PMID: 26771294RESULT

  • 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.

    PMID: 21532153RESULT

  • 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.

    PMID: 26837852RESULT

  • 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.

    PMID: 18628464RESULT

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Jose A Carreño, Md

    Instituto Nacional de Cancerologia de Mexico

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
double blind masking
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Phase II clinical trial, randomized and placebo controlled
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2020

First Posted

March 4, 2020

Study Start

December 1, 2021

Primary Completion

January 31, 2023

Study Completion

December 31, 2023

Last Updated

December 7, 2022

Record last verified: 2020-06