Evidence map›Paper›PMID 31132111›Full record

Trial reportThe Journal of nutrition2019

Curcumin Combined with FOLFOX Chemotherapy Is Safe and Tolerable in Patients with Metastatic Colorectal Cancer in a Randomized Phase IIa Trial.

Lynne M Howells, Chinenye O O Iwuji, Glen R B Irving, Shaun Barber, Harriet Walter, Zahirah Sidat, Nicola Griffin-Teall, Rajinder Singh, Nalini Foreman, Samita R Patel and 5 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in The Journal of nutrition, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01490996 (A Phase I/IIa Study Combining Curcumin), which is not on this map. Cited by 156 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
156citing papers in PubMed, 9 pooled it
5.8field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01490996 phase1 / phase2completednot on this map

A Phase I/IIa Study Combining Curcumin (Curcumin C3-Complex, Sabinsa) With Standard Care FOLFOX Chemotherapy in Patients With Inoperable Colorectal Cancer.

TypeinterventionalSponsorUniversity of LeicesterRan2012 to 2017Enrolled41ConditionsColonic Cancer, MetastasisArmsOral complex C3 curcumin + chemotherapy, Chemotherapy only
3 · Its place in the literature

Who cites it

156 citing papers in PubMed, 9 syntheses or guidelines pooled it, 227 citations in OpenAlex.

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  8. Preventing Colitis-Associated Colon Cancer With Antioxidants: A Systematic Review.Cellular and molecular gastroenterology and hepatology · 2021
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  10. Review
  11. The logarithmic phase as a therapeutic direction: evaluating pharmacological strategies against cancer progression.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
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96 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 2 institutions in 1 country.

Lynne M HowellsLeicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom.
Chinenye O O IwujiLeicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom.
Glen R B IrvingLeicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom.
Shaun BarberLeicester Clinical Trials Unit, University of Leicester, Leicester, United Kingdom.
Harriet WalterLeicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom.
Zahirah SidatHope Clinical Trials Facility, Leicester Royal Infirmary, Leicester, United Kingdom.
Nicola Griffin-TeallHope Clinical Trials Facility, Leicester Royal Infirmary, Leicester, United Kingdom.
Rajinder SinghLeicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom.
Nalini ForemanLeicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom.
Samita R PatelLeicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom.
Bruno MorganLeicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom.
William P StewardLeicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom.
Andreas GescherLeicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom.
Anne L ThomasLeicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom.
Karen BrownLeicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom.
University of Leicester · GBLeicester Royal Infirmary · GB

Funding

Cancer Research UK 13101
6 · The paper itself

Abstract

backgroundCurcumin is the main active ingredient of the spice turmeric, investigated extensively for putative anticancer properties.

objectivesThis phase IIa open-labelled randomized controlled trial aimed to assess safety, efficacy, quality of life, neurotoxicity, curcuminoids, and C-X-C-motif chemokine ligand 1 (CXCL1) in patients receiving folinic acid/5-fluorouracil/oxaliplatin chemotherapy (FOLFOX) compared with FOLFOX + 2 g oral curcumin/d (CUFOX).

methodsTwenty-eight patients aged >18 y with a histological diagnosis of metastatic colorectal cancer were randomly assigned (1:2) to receive either FOLFOX or CUFOX. Safety was assessed by Common Toxicity Criteria-Adverse Event reporting, and efficacy via progression-free survival (PFS) and overall survival (OS). Quality of life and neurotoxicity were assessed using questionnaires (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 and Functional Assessment of Cancer Treatment-Gynecologic Oncology Group-Neurotoxicity). Plasma curcuminoids were determined with liquid chromatography (LC) electrospray ionization tandem mass spectrometry and CXCL1 by ELISA.

resultsAddition of daily oral curcumin to FOLFOX chemotherapy was safe and tolerable (primary outcome). Similar adverse event profiles were observed for both arms. In the intention-to-treat population, the HR for PFS was 0.57 (95% CI: 0.24, 1.36; P = 0.2) (median of 171 and 291 d for FOLFOX and CUFOX, respectively) and for OS was 0.34 (95% CI: 0.14, 0.82; P = 0.02) (median of 200 and 502 d for FOLFOX and CUFOX, respectively). There was no significant difference between arms for quality of life (P = 0.248) or neurotoxicity (P = 0.223). Curcumin glucuronide was detectable at concentrations >1.00 pmol/mL in 15 of 18 patients receiving CUFOX. Curcumin did not significantly alter CXCL1 over time (P = 0.712).

conclusionCurcumin is a safe and tolerable adjunct to FOLFOX chemotherapy in patients with metastatic colorectal cancer. This trial was registered at clinicaltrials.gov as NCT01490996 and at www.clinicaltrialsregister.eu as EudraCT 2011-002289-19.

Indexed as

Administration, OralAgedAntineoplastic Combined Chemotherapy ProtocolsColorectal NeoplasmsCurcuminFemaleFluorouracilHumansLeucovorinMaleMiddle AgedNeoplasm MetastasisOrganoplatinum CompoundsTreatment OutcomeCurcuminFluorouracilLeucovorinOrganoplatinum CompoundscurcumincurcuminoidsFOLFOX chemotherapymetastatic colorectal cancerrandomized controlled trial

Identifiers

PMID31132111
PMCPMC6602900
OpenAlexW2947977317

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.