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Cervical Cancer, Stage IIBPhase 2NCT04294836

Curcumin in Advanced Cervical Cancer

A Phase 2 study testing Curcumin in people with Cervical Cancer, Stage IIB, run by Instituto Nacional de Cancerologia, Columbia.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Cervical Cancer, Stage IIB
What is being tested?
Curcumin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
1 Dec 2021to 31 Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%.

Who cannot join

  • 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
Show all 10Show fewer
  • 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

About this study

Official title: 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

Read the 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.

Being tested
Curcumin, Placebo oral tablet
Keywords
curcumin, natural antioxidant
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • Placebo oral tabletDrug

    PLACEBO Capsules 500mg

Study groups in NCT04294836
Study groupRoleWhat they receive
CurcuminExperimentalChemotherapy (cisplatin) plus concomitant radiation therapy (teletherapy + high or low rate brachytherapy) + Curcugreen (BCM95) 2000mg daily (each 6h)
Receives: Drug: Curcumin
PlaceboPlacebo comparatorChemotherapy (cisplatin) plus concomitant radiation therapy (teletherapy + high or low rate brachytherapy) + Placebo Capsules 500mg 2000mg daily (each 6h)
Receives: Drug: Placebo oral tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compare overall survival and progression free survival

    Global survival

    Measured: 3 yr

  2. Compare the objective response rate using RECIST radiological criteria

    Objective response by RECIST criteria

    Measured: 1 yr

  3. Compare the disease control rate

    Disease control rate

    Measured: 1 yr

Secondary outcomes (1)

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

    Common Terminology Criteria for Adverse Events (CTCAE)

    Measured: 1 yr

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2020
  2. Study start1 Dec 2021 (estimated)
  3. Primary completion31 Jan 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Why it stopped: Issues with local regulatory authority

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Phase II clinical trial, randomized and placebo controlled
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04294836
Sponsor's protocol ID
IX-023435
Status last verified
Jun 2020
First submitted
2 Mar 2020
Last updated
7 Dec 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 30427093

  • 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.

    PubMed 18252805

  • 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.

    PubMed 20160040

  • 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.

    PubMed 26771294

  • 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.

    PubMed 21532153

  • 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.

    PubMed 26837852

  • 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.

    PubMed 18628464

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Curcumin in people with Cervical Cancer, Stage IIB, run by Instituto Nacional de Cancerologia, Columbia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare overall survival and progression free survival (time frame: 3 yr). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04294836, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2022.

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