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

NCT00976131 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: AAAD8521
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

Breast Cancer; Early Stage Breast Cancer; Complementary and Alternative Medicine; CAM

Outcome Measures

Primary Outcomes (1)

• 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.

  At the end of Cycle 4 Day 2 (each cycle is 21 days)

Study Arms (2)

Arm A Placebo

PLACEBO COMPARATOR

Patients will begin taking their study pills (CoQ10) on the morning of Cycle 2 Day 3 (11-15 days prior to Cycle 3), and will continue taking the study pills through the morning of their Cycle 3 infusion (Day 1 Cycle 3). Patients will then be crossed-over to the alternative condition. On the morning of Cycle 3 Day 3, patients will begin taking their study pills (CoQ10 placebo) and will continue taking the study pills through the morning of their Cycle 4 infusion (Day 1 Cycle 4). Infusion will be standard of care chemotherapy with doxorubicin and cyclophosphamide.

Drug: CoQ10; Other: CoQ10 Placebo; Drug: Doxorubicin; Drug: Cyclophosphamide

Arm B CoQ10

EXPERIMENTAL

Patients will begin taking their study pills (CoQ10 placebo) on the morning of Cycle 2 Day 3 (11-15 days prior to Cycle 3), and will continue taking the study pills through the morning of their Cycle 3 infusion (Day 1 Cycle 3). Patients will then be crossed-over to the alternative condition. On the morning of Cycle 3 Day 3, patients will begin taking their study pills (CoQ10) and will continue taking the study pills through the morning of their Cycle 4 infusion (Day 1 Cycle 4). Infusion will be standard of care chemotherapy with doxorubicin and cyclophosphamide.

Drug: CoQ10; Other: CoQ10 Placebo; Drug: Doxorubicin; Drug: Cyclophosphamide

Interventions

CoQ10 DRUG

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)

Also known as: Coenzyme Q10

Arm A Placebo; Arm B CoQ10

CoQ10 Placebo OTHER

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)

Also known as: Coenzyme Q10 Placebo

Arm A Placebo; Arm B CoQ10

Doxorubicin DRUG

Standard of care chemotherapy medication used to treat cancer.

Also known as: Doxil

Arm A Placebo; Arm B CoQ10

Cyclophosphamide DRUG

Standard of care chemotherapy medication used to treat cancer.

Also known as: Cytoxan

Arm A Placebo; Arm B CoQ10

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

• Greenlee H, Crew KD, Maurer M, Kalinsky K, Cremers S, Naini A, Tsai WY, Shi Z, Brogan F, Hershman DL. Phase I Randomized, Placebo-Controlled, Cross-Over Dose-Finding Study of Coenzyme Q10 on Doxorubicin Pharmacokinetics during Breast Cancer Treatment. Integr Cancer Ther. 2025 Jan-Dec;24:15347354251388014. doi: 10.1177/15347354251388014. Epub 2025 Nov 19.

  PMID: 41261512 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

coenzyme Q10; Doxorubicin; liposomal doxorubicin; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Study Officials

• Heather Greenlee, ND, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2009
• First Posted: September 14, 2009
• Study Start: September 1, 2009
• Primary Completion: September 30, 2012
• Study Completion: January 20, 2021
• Last Updated: October 17, 2022

Record last verified: 2022-10

Locations

US (1)