Curcumin in Advanced Cervical Cancer

Cervical Cancer, Stage IIB Clinical Trial

Official title:

Randomized Phase II Clinical Trial of Oral Turmeric Supplementation in Patients With Advanced Cervical Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04294836
• Other study ID #: IX-023435
• Status: Withdrawn
• Phase: Phase 2
• Start date: December 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2020
• Source: Instituto Nacional de Cancerologia, Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 overall survival and disease-free survival. The safety of therapy will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) classification

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer, Stage IIB
• Uterine Cervical Neoplasms

Intervention

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 oral tablet
PLACEBO Capsules 500mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Cancerologia, Columbia

References & Publications (7)

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-08-00 — View 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. 2 — View 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. Epu — View 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. M — View 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 — View 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/b — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare overall survival and progression free survival	Global survival	3 yr
Primary	Compare the objective response rate using RECIST radiological criteria	Objective response by RECIST criteria	1 yr
Primary	Compare the disease control rate	Disease control rate	1 yr
Secondary	Describe the safety of research therapy by classifying Common Terminology Criteria for Adverse Events (CTCAE)	Common Terminology Criteria for Adverse Events (CTCAE)	1 yr