Evidence map›Paper›PMID 41261512›Full record

Trial reportIntegrative cancer therapies

Phase I Randomized, Placebo-Controlled, Cross-Over Dose-Finding Study of Coenzyme Q10 on Doxorubicin Pharmacokinetics during Breast Cancer Treatment.

Heather Greenlee, Katherine D Crew, Matthew Maurer, Kevin Kalinsky, Serge Cremers, Ali Naini, Wei Yann Tsai, Zaixing Shi, Frances Brogan, Dawn L Hershman

Registry-linked trialAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Integrative cancer therapies. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00976131 (Phase I Randomized, Placebo-Controlled, Cross-Over, Dose-Finding Pharmacokinetic Study of CoQ10 During One Cycle of Doxorubicin Treatment for Breast Cancer), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT00976131 phase1completednot on this map

Phase I Randomized, Placebo-Controlled, Cross-Over, Dose-Finding Pharmacokinetic Study of CoQ10 During One Cycle of Doxorubicin Treatment for Breast Cancer

TypeinterventionalSponsorColumbia UniversityRan2009 to 2021Enrolled7ConditionsBreast CancerArmsCoQ10, CoQ10 Placebo, Doxorubicin, Cyclophosphamide
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
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

10 authors.

Heather GreenleeColumbia University, New York, NY, USA.ORCID 0000-0003-4148-1405
Katherine D CrewColumbia University, New York, NY, USA.ORCID 0000-0002-9637-2962
Matthew MaurerColumbia University, New York, NY, USA.
Kevin KalinskyColumbia University, New York, NY, USA.
Serge CremersColumbia University, New York, NY, USA.
Ali NainiColumbia University, New York, NY, USA.
Wei Yann TsaiColumbia University, New York, NY, USA.
Zaixing ShiColumbia University, New York, NY, USA.ORCID 0000-0001-5518-0684
Frances BroganColumbia University, New York, NY, USA.
Dawn L HershmanColumbia University, New York, NY, USA.

Funding

Clinical and Translational Science AwardUL1TR001873 · NCATS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI REILLY, MUREDACH P · 2016 to 2025
$99.0M
Effects of Antioxidant Supplementation during Breast Cancer Adjuvant TherapyK23CA141052 · NCI · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI GREENLEE, HEATHER · 2009 to 2013
$753k
NCATS NIH HHS UL1 TR001873NCI NIH HHS K23 CA141052
6 · The paper itself

Abstract

aimTo determine effects of Coenzyme Q10 (CoQ10) supplementation in breast cancer patients receiving doxorubicin treatment.

methodsPhase I randomized, placebo-controlled, cross-over, dose-finding study among women with stage I-III breast cancer receiving 4 cycles of doxorubicin plus cyclophosphamide. The study was designed to test effects on doxorubicin pharmacokinetic parameters when administering up to the maximum tolerated dose of CoQ10 of 1200 mg/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

resultsSix patients received 300 mg/day of CoQ10 (Arm A [n = 3], Arm B [n = 3]). One patient received 600 mg/day of CoQ10 but was discontinued due to non-adherence. Serum CoQ10 concentrations were increased in patients receiving 300 mg/day (mean ± SD change: CoQ10, 1.6 ± 0.9 µg/mL; placebo, -0.01 ± 0.3 µg/mL; P = .01). There were no clinically significant pharmacokinetic interactions between 300 mg/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.

conclusion300 mg/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 mg/day and safety studies should examine higher doses.

trial registrationClinicalTrials.gov: NCT00976131.

Indexed as

Breast NeoplasmsDoxorubicinUbiquinoneAdultAgedAntibiotics, AntineoplasticAntineoplastic Combined Chemotherapy ProtocolsCross-Over StudiesCyclophosphamideDose-Response Relationship, DrugFemaleHumansMaximum Tolerated DoseMiddle AgedAntibiotics, Antineoplasticcoenzyme Q10CyclophosphamideDoxorubicinUbiquinonebreast cancercoenzyme Q10doxorubicinpharmacokinetics

Identifiers

PMID41261512
PMCPMC12638730

What OpenQuestion holds

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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.