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Study of CoQ10 During One Cycle of Doxorubicin Treatment for Breast Cancer

2014-08-27 03:19:23 | BioPortfolio

Summary

This research study hopes to examine the effects of Coenzyme Q10 on doxorubicin (Adriamycin) metabolism during breast cancer treatment. Doxorubicin is a lifesaving breast cancer treatment.

However, approximately 3-20% of women who receive doxorubicin treatment experience some damage to their heart muscle. Coenzyme Q10 is a fat soluble antioxidant dietary supplement that may protect against this heart damage during doxorubicin treatment. It is unknown how Coenzyme Q10 may interact with doxorubicin. This study will assess the effects of Coenzyme Q10 on doxorubicin metabolism.

Description

This is a phase I randomized, placebo-controlled, cross-over pharmacokinetic and dose-finding study to assess the safety of CoQ10 during doxorubicin treatment for breast cancer in a maximum of 18 patients. Safety will be assessed by measuring 1) intra-patient differences in doxorubicin and its active metabolites, with and without CoQ10, and 2) adverse events. We hypothesize that CoQ10 administration during doxorubicin treatment is safe and will not affect doxorubicin active metabolites. Using three dose levels of CoQ10, the maximum tolerated dose (MTD) will be determined by assessing change in doxorubicin concentration (area under the curve (AUC), change in peak concentration levels (Cmax)), and adverse events.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Conditions

Breast Cancer

Intervention

Coenzyme Q10, Coenzyme Q10 Placebo

Location

Columbia University Medical Center
New York
New York
United States
10032

Status

Recruiting

Source

Columbia University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:23-0400

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Natural compounds containing alternating carbonyl and methylene groups (beta-polyketones), bioenergenetically derived from repeated condensation of acetyl coenzyme A via malonyl coenzyme A, in a process similar to fatty acid synthesis.

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