Clinical trial · Interventional
Curcumin in Advanced Cervical Cancer
Randomized Phase II Clinical Trial of Oral Turmeric Supplementation in Patients With Advanced Cervical Cancer
NCT04294836CI-TRIAL-00062534withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Issues with local regulatory authority
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer, Stage IIB | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Curcumin | Drug | — | UNRESOLVED |
| Placebo oral tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Curcumin
- description
- Chemotherapy (cisplatin) plus concomitant radiation therapy (teletherapy + high or low rate brachytherapy) + Curcugreen (BCM95) 2000mg daily (each 6h)
- interventionNames
- Drug: Curcumin
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Chemotherapy (cisplatin) plus concomitant radiation therapy (teletherapy + high or low rate brachytherapy) + Placebo Capsules 500mg 2000mg daily (each 6h)
- interventionNames
- Drug: Placebo oral tablet
Primary outcomes (3)
- measure
- Compare overall survival and progression free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (7)
- RESULTSaadipoor 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 30427093
- RESULTJavvadi 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 18252805
- RESULTJavvadi 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 20160040
- RESULTHejazi 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 26771294
- RESULTSasaki 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 21532153
- RESULTZaman 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 26837852