Curcumin Combined with FOLFOX Chemotherapy Is Safe and Tolerable in Patients with Metastatic Colorectal Cancer in a Randomized Phase IIa Trial
Curcumin is the main active ingredient of the spice turmeric, investigated extensively for putative anticancer properties. This 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 (CXCL...
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| Published in: | The Journal of nutrition Vol. 149; no. 7; p. 1133 |
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| Main Authors: | , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
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United States
01.07.2019
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| ISSN: | 1541-6100, 1541-6100 |
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| Abstract | Curcumin is the main active ingredient of the spice turmeric, investigated extensively for putative anticancer properties.
This 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).
Twenty-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.
Addition 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).
Curcumin 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. |
|---|---|
| AbstractList | Curcumin is the main active ingredient of the spice turmeric, investigated extensively for putative anticancer properties.
This 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).
Twenty-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.
Addition 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).
Curcumin 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. Curcumin is the main active ingredient of the spice turmeric, investigated extensively for putative anticancer properties.BACKGROUNDCurcumin is the main active ingredient of the spice turmeric, investigated extensively for putative anticancer properties.This 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).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).Twenty-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.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.Addition 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).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).Curcumin 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.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. |
| Author | Iwuji, Chinenye O O Morgan, Bruno Thomas, Anne L Steward, William P Howells, Lynne M Singh, Rajinder Foreman, Nalini Brown, Karen Irving, Glen R B Patel, Samita R Barber, Shaun Gescher, Andreas Walter, Harriet Sidat, Zahirah Griffin-Teall, Nicola |
| Author_xml | – sequence: 1 givenname: Lynne M surname: Howells fullname: Howells, Lynne M organization: Leicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom – sequence: 2 givenname: Chinenye O O surname: Iwuji fullname: Iwuji, Chinenye O O organization: Leicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom – sequence: 3 givenname: Glen R B surname: Irving fullname: Irving, Glen R B organization: Leicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom – sequence: 4 givenname: Shaun surname: Barber fullname: Barber, Shaun organization: Leicester Clinical Trials Unit, University of Leicester, Leicester, United Kingdom – sequence: 5 givenname: Harriet surname: Walter fullname: Walter, Harriet organization: Leicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom – sequence: 6 givenname: Zahirah surname: Sidat fullname: Sidat, Zahirah organization: Hope Clinical Trials Facility, Leicester Royal Infirmary, Leicester, United Kingdom – sequence: 7 givenname: Nicola surname: Griffin-Teall fullname: Griffin-Teall, Nicola organization: Hope Clinical Trials Facility, Leicester Royal Infirmary, Leicester, United Kingdom – sequence: 8 givenname: Rajinder surname: Singh fullname: Singh, Rajinder organization: Leicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom – sequence: 9 givenname: Nalini surname: Foreman fullname: Foreman, Nalini organization: Leicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom – sequence: 10 givenname: Samita R surname: Patel fullname: Patel, Samita R organization: Leicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom – sequence: 11 givenname: Bruno surname: Morgan fullname: Morgan, Bruno organization: Leicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom – sequence: 12 givenname: William P surname: Steward fullname: Steward, William P organization: Leicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom – sequence: 13 givenname: Andreas surname: Gescher fullname: Gescher, Andreas organization: Leicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom – sequence: 14 givenname: Anne L surname: Thomas fullname: Thomas, Anne L organization: Leicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom – sequence: 15 givenname: Karen surname: Brown fullname: Brown, Karen organization: Leicester Cancer Research Centre, University of Leicester, Leicester, United Kingdom |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/31132111$$D View this record in MEDLINE/PubMed |
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| Snippet | Curcumin is the main active ingredient of the spice turmeric, investigated extensively for putative anticancer properties.
This phase IIa open-labelled... Curcumin is the main active ingredient of the spice turmeric, investigated extensively for putative anticancer properties.BACKGROUNDCurcumin is the main active... |
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| SubjectTerms | Administration, Oral Aged Antineoplastic Combined Chemotherapy Protocols - administration & dosage Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Colorectal Neoplasms - drug therapy Colorectal Neoplasms - pathology Curcumin - administration & dosage Curcumin - therapeutic use Female Fluorouracil - administration & dosage Fluorouracil - therapeutic use Humans Leucovorin - administration & dosage Leucovorin - therapeutic use Male Middle Aged Neoplasm Metastasis Organoplatinum Compounds - administration & dosage Organoplatinum Compounds - therapeutic use Treatment Outcome |
| Title | Curcumin Combined with FOLFOX Chemotherapy Is Safe and Tolerable in Patients with Metastatic Colorectal Cancer in a Randomized Phase IIa Trial |
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