Clinical trial NCT04294836: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Cervical Cancer, Stage IIB
Keywords: curcumin
natural antioxidant
Lead sponsor: Instituto Nacional de Cancerologia, Columbia
Sponsor class: OTHER_GOV
First posted: 2020-03-04
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase II clinical trial, randomized and placebo controlled
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Compare overall survival and progression free survival
timeFrame: 3 yr
measure: Compare the objective response rate using RECIST radiological criteria
timeFrame: 1 yr
measure: Compare the disease control rate
timeFrame: 1 yr
Secondary outcomes:
measure: Describe the safety of research therapy by classifying Common Terminology Criteria for Adverse Events (CTCAE)
timeFrame: 1 yr
Other outcomes:
Locations:
Study officials:
affiliation: Instituto Nacional de Cancerologia de Mexico
name: Jose A Carreño, Md
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.