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The study was designed to test effects on doxorubicin pharmacokinetic parameters when administering up to the maximum tolerated dose of CoQ10 of 1200\u2009mg\/day. Eligible patients were randomized to Arm A (CoQ10 after Cycle 3, followed by placebo after Cycle 4) or Arm B (placebo after Cycle 3, followed by CoQ10 after Cycle 4). CoQ10 concentrations and total antioxidant capacity (TAC) were measured before and after chemotherapy cycles. Non-compartmental pharmacokinetic parameters of doxorubicin and its active metabolites were measured with and without CoQ10. Paired\n                      <jats:italic toggle=\"yes\">t<\/jats:italic>\n                      -tests assessed intra-patient differences in pharmacokinetic parameters, serum CoQ10 concentrations, TAC, and adverse events.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Six patients received 300\u2009mg\/day of CoQ10 (Arm A [n\u2009=\u20093], Arm B [n\u2009=\u20093]). One patient received 600\u2009mg\/day of CoQ10 but was discontinued due to non-adherence. Serum CoQ10 concentrations were increased in patients receiving 300\u2009mg\/day (mean\u2009\u00b1\u2009SD change: CoQ10, 1.6\u2009\u00b1\u20090.9\u2009\u00b5g\/mL; placebo, \u22120.01\u2009\u00b1\u20090.3\u2009\u00b5g\/mL; P\u2009=\u2009.01). There were no clinically significant pharmacokinetic interactions between 300\u2009mg\/day CoQ10 and doxorubicin and no differences in TAC or adverse events during treatment and nontreatment periods. The trial was closed early due to slow accrual.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>300\u2009mg\/day of CoQ10 with doxorubicin did not change doxorubicin pharmacokinetics and was not associated with treatment-related adverse events. Future studies should evaluate the long-term effects of CoQ10 at 300\u2009mg\/day and safety studies should examine higher doses.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration:<\/jats:title>\n                    <jats:p>ClinicalTrials.gov: NCT00976131.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/15347354251388014","type":"journal-article","created":{"date-parts":[[2025,11,20]],"date-time":"2025-11-20T05:18:57Z","timestamp":1763615937000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":4,"title":["Phase I Randomized, Placebo-Controlled, Cross-Over Dose-Finding Study of Coenzyme Q10 on Doxorubicin Pharmacokinetics during Breast Cancer Treatment"],"prefix":"10.1177","volume":"24","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4148-1405","authenticated-orcid":false,"given":"Heather","family":"Greenlee","sequence":"first","affiliation":[{"name":"Columbia University, New York, NY, USA"},{"name":"Fred Hutchinson Cancer Center, Seattle, WA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9637-2962","authenticated-orcid":false,"given":"Katherine D.","family":"Crew","sequence":"additional","affiliation":[{"name":"Columbia University, New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew","family":"Maurer","sequence":"additional","affiliation":[{"name":"Columbia University, New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin","family":"Kalinsky","sequence":"additional","affiliation":[{"name":"Columbia University, New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Serge","family":"Cremers","sequence":"additional","affiliation":[{"name":"Columbia University, New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ali","family":"Naini","sequence":"additional","affiliation":[{"name":"Columbia University, New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei Yann","family":"Tsai","sequence":"additional","affiliation":[{"name":"Columbia University, New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5518-0684","authenticated-orcid":false,"given":"Zaixing","family":"Shi","sequence":"additional","affiliation":[{"name":"Columbia University, New York, NY, USA"},{"name":"Fred Hutchinson Cancer Center, Seattle, WA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frances","family":"Brogan","sequence":"additional","affiliation":[{"name":"Columbia University, New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dawn L.","family":"Hershman","sequence":"additional","affiliation":[{"name":"Columbia University, New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2025,11,19]]},"reference":[{"key":"e_1_3_3_2_2","unstructured":"National Cancer Institute. 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