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

Phase 1
21 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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

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.

Inclusion Criteria:

- Diagnosis of early stage breast cancer (stage I, II, or III);

- Scheduled to receive at least four rounds of dose dense doxorubicin therapy in the
neoadjuvant or adjuvant setting;

- No other history of prior chemotherapy, radiation, or hormonal therapy in the
previous 5 years;

- For women receiving adjuvant therapy, single lumen implanted venous access device
(i.e. single port) for unilateral cancer and double lumen implanted venous access
device (i.e. double port) for bilateral breast cancer

- Age 21 years or older;

- ECOG performance status ≤ 2 (Karnofsky > 60%);

- Normal organ and marrow function defined as: Leukocytes ≥ 3,000/uL, Absolute
neutrophils count (ANC) ≥ 1,500/uL at baseline, Platelets ≥ 100,000/uL, Total
bilirubin ≤ 1.5 X normal institutional limits, AST (SGOT)/ALT (SGPT) ≤ 2.5 X
institutional ULN, Serum creatinine within normal institutional limits;

- Left ventricular ejection fraction > 55%;

- No history of CoQ10 supplement use within 30 days of initiating study drug;

- No uncontrolled or significant co-morbid illness;

- Not pregnant, not breastfeeding, and not planning on becoming pregnant during the
course of the study;

- Willingness to comply with all study intervention and follow-up procedures;

- Ability to speak English or Spanish; and

- Ability to provide informed consent.

Exclusion Criteria:

- Inability to understand or an unwillingness to sign a written informed consent

- Any significant toxic side effects related to first or second dose of
doxorubicin/cyclophosphamide chemotherapy or biologic therapy that did not resolve to
less than a CTCAE 3.0 grade 3 non-hematological toxicity;

- Currently using any investigational agent;

- Unstable or severe intercurrent medical condition that, in the opinion of the
investigator, might interfere with the participant's ability to follow the protocol
or achieve study objectives;

- Psychological or sociological conditions, addictive disorders, or family problems
that would preclude adherence with study drug or compliance with the protocol

- Women who report pregnancy, are breast feeding, or have a positive pregnancy test;

- Use of CoQ10 supplement use within 30 days of initiating study drug;

- Use of over-the-counter nutritional vitamin greater than 5x RDA;

- Fish allergy (due to fish-based softgel shell);

- Currently taking FDA cardioprotective drugs, such as Zinecard (dexrazoxane);

- History of chronic hepatitis B, hepatitis C, and HIV infection;

- Problems swallowing oral medications due to prolonged emesis, mucositis, esophageal
dysfunction, etc.; and,

- Currently taking any form of antioxidant supplements while on study.

- Use of warfarin.

- Kosher (due to fish-based softgel shell)

- Dietary restriction of tilipia (due to tilipia fish-based softgel shell)

- Titanium Dioxide allergy (due to the opaque coloring used in the softgel).

Type of Study:


Study Design:

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

Outcome Measure:

To determine the maximum tolerated dose of CoQ10 that does not alter the pharmacokinetics of doxorubicin

Outcome Time Frame:

Two weeks prior to cycles 3 and 4 of doxorubicin

Safety Issue:


Principal Investigator

Heather Greenlee, ND, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University


United States: Food and Drug Administration

Study ID:




Start Date:

September 2009

Completion Date:

September 2013

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Early Stage Breast Cancer
  • Complementary and Alternative Medicine
  • CAM
  • Breast Neoplasms



Columbia University Medical Center New York, New York  10032