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. 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. Safety will be assessed by measuring 1) intra-patient differences in doxorubicin and its active metabolites, with and without CoQ10, and 2) adverse events. The investigator hypothesizes 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
7
Capsules taken daily for two weeks prior to Cycle 3 chemotherapy infusion OR Capsules taken daily for two weeks prior to Cycle 4 infusion. Dose Level 1: 300mg/d CoQ10 (2 capsules) Dose Level 2: 600mg/d CoQ10 (4 capsules) Dose Level 3: 1200mg/d CoQ10 (8 capsules)
Capsules taken daily for two weeks prior to Cycle 3 chemotherapy infusion OR Capsules taken daily for two weeks prior to Cycle 4 infusion. Dose Level 1: 300mg/d placebo (2 capsules) Dose Level 2: 600mg/d placebo (4 capsules) Dose Level 3: 1200mg/d placebo (8 capsules)
Standard of care chemotherapy medication used to treat cancer.
Columbia University Medical Center
New York, New York, United States
Maximum tolerated dose of CoQ10 that does not alter the pharmacokinetics of doxorubicin
To test increasing doses on different groups of people until the highest dose with acceptable side effects is found.
Time frame: At the end of Cycle 4 Day 2 (each cycle is 21 days)
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Standard of care chemotherapy medication used to treat cancer.