Breast CancerPhase 1NCT00976131
Study of CoQ10 During One Cycle of Doxorubicin Treatment for Breast Cancer
A Phase 1 study testing CoQ10, Doxorubicin and Cyclophosphamide in people with Breast Cancer, run by Columbia University at 1 site in United States.
Trial summary
This research study hopes to examine the effects of Coenzyme Q10 on doxorubicin (Adriamycin) metabolism during breast cancer treatment. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- CoQ10, Doxorubicin and Cyclophosphamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to 20 Jan 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%);
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- 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.
Who cannot join
- 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;
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- 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 tilapia (due to tilapia fish-based softgel shell)
- Titanium Dioxide allergy (due to the opaque coloring used in the softgel).
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Phase I Randomized, Placebo-Controlled, Cross-Over, Dose-Finding Pharmacokinetic Study of CoQ10 During One Cycle of Doxorubicin Treatment for Breast Cancer
This research study hopes to examine the effects of Coenzyme Q10 on doxorubicin (Adriamycin) metabolism during breast cancer treatment.
Read the detailed description
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.
- Conditions
- Breast Cancer
- Being tested
- CoQ10, CoQ10 Placebo, Doxorubicin, Cyclophosphamide
- Keywords
- Breast Cancer, Early Stage Breast Cancer, Complementary and Alternative Medicine, CAM
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoQ10Drug
Also called Coenzyme Q10
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)
CoQ10 PlaceboOther
Also called Coenzyme Q10 Placebo
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)
DoxorubicinDrug
Also called Doxil
Standard of care chemotherapy medication used to treat cancer.
CyclophosphamideDrug
Also called Cytoxan
Standard of care chemotherapy medication used to treat cancer.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: CoQ10; Other: CoQ10 Placebo; Drug: Doxorubicin; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of Cycle 4 Day 2 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2009 (estimated)
- Study startSep 2009
- Primary completion30 Sep 2012
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Greenlee, ND, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00976131
- Sponsor's protocol ID
- AAAD8521
- Status last verified
- Oct 2022
- First submitted
- 11 Sep 2009
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41261512
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Randomized, Placebo-Controlled, Cross-Over, Dose-Finding Pharmacokinetic Study of CoQ10 During One Cycle of Doxorubicin Treatment for Breast Cancer
- ClinicalTrials.gov ID
- NCT00976131
- Acronym / sponsor ID
- AAAD8521
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Early Stage Breast Cancer, Complementary and Alternative Medicine, CAM
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Sep 2009 (actual)
- Primary completion
- 30 Sep 2012 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 14 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study hopes to examine the effects of Coenzyme Q10 on doxorubicin (Adriamycin) metabolism during breast cancer treatment.
Detailed description
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A Placebo | Placebo comparator | Drug: CoQ10, Other: CoQ10 Placebo, Drug: Doxorubicin, Drug: CyclophosphamidePatients 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. |
| Arm B CoQ10 | Experimental | Drug: CoQ10, Other: CoQ10 Placebo, Drug: Doxorubicin, Drug: CyclophosphamidePatients 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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;
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoQ10Also: Coenzyme Q10Capsules 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) | Drug | Arm A Placebo, Arm B CoQ10 |
| CoQ10 PlaceboAlso: Coenzyme Q10 PlaceboCapsules 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) | Other | Arm A Placebo, Arm B CoQ10 |
| DoxorubicinAlso: DoxilStandard of care chemotherapy medication used to treat cancer. | Drug | Arm A Placebo, Arm B CoQ10 |
| CyclophosphamideAlso: CytoxanStandard of care chemotherapy medication used to treat cancer. | Drug | Arm A Placebo, Arm B CoQ10 |
Primary outcome
Maximum tolerated dose of CoQ10 that does not alter the pharmacokinetics of doxorubicin
Time frame: At the end of Cycle 4 Day 2 (each cycle is 21 days)
To test increasing doses on different groups of people until the highest dose with acceptable side effects is found.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- Derived from this study: PubMed 41261512Greenlee 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Greenlee, ND, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CoQ10, Doxorubicin and Cyclophosphamide in people with Breast Cancer, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose of CoQ10 that does not alter the pharmacokinetics of doxorubicin (time frame: At the end of Cycle 4 Day 2 (each cycle is 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00976131, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2022.