Clinical trial · Interventional
Combining Curcumin With FOLFOX Chemotherapy in Patients With Inoperable Colorectal Cancer
A Phase I/IIa Study Combining Curcumin (Curcumin C3-Complex, Sabinsa) With Standard Care FOLFOX Chemotherapy in Patients With Inoperable Colorectal Cancer.
NCT01490996CI-TRIAL-00043125CUFOXcompletedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Oral curcumin (complex C3, Sabinsa Corp, Utah) will be given to patients with inoperable colorectal metastases who will be commencing standard care oxaliplatin-based (FOLFOX) chemotherapy for up to 12 cycles(approximately 6 months) of treatment. Primary measurements focus on safety and tolerability. These will be recorded in real-time and report the number and severity of adverse events. Secondary measurements will include efficacy, (measured by response rate with RECIST and overall survival in months) supported by biomarker analysis.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonic Cancer | — | UNRESOLVED | — |
| Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy only | Drug | — | UNRESOLVED |
| Oral complex C3 curcumin + chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Chemotherapy only
- description
- Patients receiving up to 12 cycles of therapy. Standard care pathway management.
- interventionNames
- Drug: Chemotherapy only
- type
- EXPERIMENTAL
- label
- Chemotherapy plus curcumin
- description
- Patients taking daily oral curcumin for up to 12 cycles of therapy. Standard care pathway management.
- interventionNames
- Drug: Oral complex C3 curcumin + chemotherapy
Primary outcomes (1)
- measure
- Completion of dose escalation over 2 cycles of therapy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological or cytological diagnosis of metastatic colorectal cancer * Measurable disease by Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) (Appendix 1) * Adequate haematological, hepatic and renal function * Age ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1 * Patients must have recovered from effects of any recent major surgery * Willing to use contraception if applicable * Informed consent * Life expectancy estimated to be more than 12 weeks Exclusion Criteria: * Main exclusion criteria * Contraindications to FOLFOX chemotherapy: Peripheral neuropathy NCI CTC \>1, Liver failure, uncontrolled coronary heart disease, myocardial infarction within the previous 6 months. * Unwilling or unable to comply with the study protocol. * Patients who are pregnant or lactating or contemplating pregnancy. Patients or their partners who become pregnant during the study will be referred to the appropriate experts. * Undergone chemotherapy (other than adjuvant for CRC) or participating in another drug study. * Previous cancer \<5 years (other than colorectal, basal cell carcinoma, in-situ cervical cancer). * Major surgery within 4 weeks of starting the study * Co-existing active infection or serious concurrent medical condition * Significant cardiovascular disease * Bone metastases * Known brain or leptomeningeal metastases * Surgery or hospital admissions for symptomatic intra-abdominal adhesions * Active endoscopically proven peptic ulcer disease or colitis
References
Publications (3)
- DERIVEDHowells LM, Iwuji COO, Irving GRB, Barber S, Walter H, Sidat Z, Griffin-Teall N, Singh R, Foreman N, Patel SR, Morgan B, Steward WP, Gescher A, Thomas AL, Brown K. Curcumin Combined with FOLFOX Chemotherapy Is Safe and Tolerable in Patients with Metastatic Colorectal Cancer in a Randomized Phase IIa Trial. J Nutr. 2019 Jul 1;149(7):1133-1139. doi: 10.1093/jn/nxz029. PMID 31132111
- DERIVEDJames MI, Iwuji C, Irving G, Karmokar A, Higgins JA, Griffin-Teal N, Thomas A, Greaves P, Cai H, Patel SR, Morgan B, Dennison A, Metcalfe M, Garcea G, Lloyd DM, Berry DP, Steward WP, Howells LM, Brown K. Curcumin inhibits cancer stem cell phenotypes in ex vivo models of colorectal liver metastases, and is clinically safe and tolerable in combination with FOLFOX chemotherapy. Cancer Lett. 2015 Aug 10;364(2):135-41. doi: 10.1016/j.canlet.2015.05.005. Epub 2015 May 12. PMID 25979230
- DERIVEDIrving GR, Iwuji CO, Morgan B, Berry DP, Steward WP, Thomas A, Brown K, Howells LM. Combining curcumin (C3-complex, Sabinsa) with standard care FOLFOX chemotherapy in patients with inoperable colorectal cancer (CUFOX): study protocol for a randomised control trial. Trials. 2015 Mar 24;16:110. doi: 10.1186/s13063-015-0641-1. PMID 25872567