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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Columbia University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Heather Greenlee, Columbia University
ClinicalTrials.gov Identifier:
NCT00976131
First received: September 11, 2009
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Coenzyme Q10
Other: Coenzyme Q10 Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: Phase I Randomized, Placebo-Controlled, Cross-Over, Dose-Finding Pharmacokinetic Study of CoQ10 During One Cycle of Doxorubicin Treatment for Breast Cancer

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • To determine the maximum tolerated dose of CoQ10 that does not alter the pharmacokinetics of doxorubicin [ Time Frame: Two weeks prior to cycles 3 and 4 of doxorubicin ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 18
Study Start Date: September 2009
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm A
Cycle 3 of doxorubicin with CoQ10, Cycle 4 with placebo
Drug: Coenzyme Q10

Dose Level 1:

300mg/d (2 capsules) of CoQ10 taken daily for two weeks prior to Cycle 3 infusion of doxorubicin followed by 300mg/d placebo (2 capsules)taken daily for two weeks prior to Cycle 4 infusion of doxorubicin.

Dose Level 2:

600mg/d (4 capsules) of CoQ10 taken daily for two weeks prior to Cycle 3 infusion of doxorubicin followed by 600mg/d placebo (4 capsules) taken daily for two weeks prior to Cycle 4 infusion of doxorubicin.

Dose Level 3:

1200mg/d (8 capsules) of CoQ10 taken daily for two weeks prior to Cycle 3 infusion of doxorubicin followed by 1200mg/d placebo (8 capsules) taken daily for two weeks prior to Cycle 4 infusion of doxorubicin.

Experimental: Arm B
Cycle 3 of doxorubicin with placebo, Cycle 4 with CoQ10
Other: Coenzyme Q10 Placebo

Dose Level 1:

300mg/d placebo (2 capsules) taken daily two weeks prior to Cycle 3 infusion of doxorubicin followed by 300mg/d (2 capsules) of CoQ10 taken daily two weeks prior to Cycle 4 infusion of doxorubicin.

Dose Level 2:

600mg/d placebo (4 capsules) taken daily two weeks prior to Cycle 3 infusion of doxorubicin followed by 600mg/d (4 capsules) of CoQ10 taken daily two weeks prior to Cycle 4 infusion of doxorubicin.

Dose Level 3:

1200mg/d placebo (8 capsules) taken daily two weeks prior to Cycle 3 infusion of doxorubicin followed by 1200mg/d (8 capsules) of CoQ10 taken daily two weeks prior to Cycle 4 infusion of doxorubicin.


Detailed 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 document;
  • 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00976131

Contacts
Contact: Herbert Irving Comprehensive Cancer Center Clinical Research Management Office 212-305-8615

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Principal Investigator: Heather Greenlee, ND, PhD         
Sub-Investigator: Dawn Hershman, MD, MS         
Sub-Investigator: Katherine Crew, MD, MS         
Sub-Investigator: Matthew Maurer, MD         
Sub-Investigator: Serge Cremers, PharmD, PhD         
Sub-Investigator: Kevin Kalinsky, MD         
Sponsors and Collaborators
Heather Greenlee
Investigators
Principal Investigator: Heather Greenlee, ND, PhD Columbia University
  More Information

No publications provided

Responsible Party: Heather Greenlee, Assistant Professor of Epidemiology, Columbia University
ClinicalTrials.gov Identifier: NCT00976131     History of Changes
Other Study ID Numbers: AAAD8521
Study First Received: September 11, 2009
Last Updated: February 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Columbia University:
Breast Cancer
Early Stage Breast Cancer
Complementary and Alternative Medicine
CAM

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Physiological Effects of Drugs
Breast Diseases
Skin Diseases
Doxorubicin
Coenzyme Q10
Ubiquinone
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Micronutrients
Growth Substances
Vitamins

ClinicalTrials.gov processed this record on July 28, 2014