| Phase I clinical trial of curcumin, a chemopreventive agent, in patients with high-risk or pre-malignant lesions. | |
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MedLine Citation:
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PMID: 11712783 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Curcumin (diferuloylmethane), a yellow substance from the root of the plant Curcuma longa Linn., has been demonstrated to inhibit carcinogenesis of murine skin, stomach, intestine and liver. However, the toxicology, pharmacokinetics and biologically effective dose of curcumin in humans have not been reported. This prospective phase-I study evaluated these issues of curcumin in patients with one of the following five high-risk conditions: 1) recently resected urinary bladder cancer; 2) arsenic Bowen's disease of the skin; 3) uterine cervical intraepithelial neoplasm (CIN); 4) oral leucoplakia; and 5) intestinal metaplasia of the stomach. Curcumin was taken orally for 3 months. Biopsy of the lesion sites was done immediately before and 3 months after starting curcumin treament. The starting dose was 500 mg/day. If no toxicity > or = grade II was noted in at least 3 successive patients, the dose was then escalated to another level in the order of 1,000, 2,000, 4,000, 8,000, and 12,000 mg/day. The concentration of curcumin in serum and urine was determined by high pressure liquid chromatography (HPLC). A total of 25 patients were enrolled in this study. There was no treatment-related toxicity up to 8,000 mg/day. Beyond 8,000 mg/day, the bulky volume of the drug was unacceptable to the patients. The serum concentration of curcumin usually peaked at 1 to 2 hours after oral intake of crucumin and gradually declined within 12 hours. The average peak serum concentrations after taking 4,000 mg, 6,000 mg and 8,000 mg of curcumin were 0.51 +/- 0.11 microM, 0.63 +/- 0.06 microM and 1.77 +/- 1.87 microM, respectively. Urinary excretion of curcumin was undetectable. One of 4 patients with CIN and 1 of 7 patients with oral leucoplakia proceeded to develop frank malignancies in spite of curcumin treatment. In contrast, histologic improvement of precancerous lesions was seen in 1 out of 2 patients with recently resected bladder cancer, 2 out of 7 patients of oral leucoplakia, 1 out of 6 patients of intestinal metaplasia of the stomach, I out of 4 patients with CIN and 2 out of 6 patients with Bowen's disease. In conclusion, this study demonstrated that curcumin is not toxic to humans up to 8,000 mg/day when taken by mouth for 3 months. Our results also suggest a biologic effect of curcumin in the chemoprevention of cancer. |
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Authors:
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A L Cheng; C H Hsu; J K Lin; M M Hsu; Y F Ho; T S Shen; J Y Ko; J T Lin; B R Lin; W Ming-Shiang; H S Yu; S H Jee; G S Chen; T M Chen; C A Chen; M K Lai; Y S Pu; M H Pan; Y J Wang; C C Tsai; C Y Hsieh |
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Publication Detail:
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Type: Clinical Trial; Clinical Trial, Phase I; Comparative Study; Journal Article; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Anticancer research Volume: 21 ISSN: 0250-7005 ISO Abbreviation: Anticancer Res. Publication Date: 2001 Jul-Aug |
Date Detail:
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Created Date: 2001-11-19 Completed Date: 2001-12-10 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 8102988 Medline TA: Anticancer Res Country: Greece |
Other Details:
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Languages: eng Pagination: 2895-900 Citation Subset: IM |
Affiliation:
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Department of Internal Medicine, National Taiwan University College of Medicine, Taipei. andrew@ha.mc.ntu.edu.tw |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Anticarcinogenic Agents / administration & dosage, adverse effects, pharmacokinetics, therapeutic use* Arsenicals / adverse effects Bowen's Disease / chemically induced, drug therapy* Carcinoma, Transitional Cell / drug therapy* Cervical Intraepithelial Neoplasia / drug therapy* Curcumin / administration & dosage, adverse effects, pharmacokinetics, therapeutic use* Dose-Response Relationship, Drug Female Humans Leukoplakia, Oral / drug therapy* Male Metaplasia Middle Aged Neoplasm Recurrence, Local / prevention & control Precancerous Conditions / drug therapy* Prospective Studies Risk Skin Neoplasms / chemically induced, drug therapy* Stomach / pathology* Stomach Neoplasms / prevention & control* Treatment Outcome Urinary Bladder Neoplasms / drug therapy* Uterine Cervical Neoplasms / drug therapy* |
| Chemical | |
Reg. No./Substance:
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0/Anticarcinogenic Agents; 0/Arsenicals; 458-37-7/Curcumin |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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