Breast NeoplasmsNCT05146843
The Impact of Chronic Mitochondrial Antioxidant Supplementation on CardiovascularToxicity in Breast Cancer Patients
A study testing Mitoquinone in people with Breast Neoplasms, run by D'Or Institute for Research and Education.
Trial summary
Investigate the protective effect of chronic MitoQ supplementation on cardiovascular toxicity induced by doxorubicin-based adjuvant chemotherapy in breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Mitoquinone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 2 Jun 2022to 2 Dec 2023
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥18 years old, diagnosed with breast cancer (ductal, lobular and mixed carcinoma), in stage 1-3, with indication for the adjuvant AC-T therapeutic scheme, doxorubicin (60 mg/m2) plus cyclophosphamide, will be considered eligible for the study (600 mg/m2) in the regimen of 1 cycle every 21 days, followed by weekly taxane for 12 cycles.
Who cannot join
- Patients with metastasis, severe lymphedema, renal failure, acute myocardial infarction, heart failure, stroke and chronic liver disease.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Impact of Chronic Mitochondrial Antioxidant (MitoQ) Supplementation on Cardiovascular Toxicity Induced by Doxorubicin-Based Adjuvant Chemotherapy in Breast Cancer Patients: Randomized Clinical Trial
Investigate the protective effect of chronic MitoQ supplementation on cardiovascular toxicity induced by doxorubicin-based adjuvant chemotherapy in breast cancer patients.
Read the detailed description
Test the hypothesis that chronic MitoQ supplementation in breast cancer patients treated with doxorubicin prevents:
- increased mitochondrial oxidative stress;
- the increase in cardiac markers (B-type natriuretic peptide and troponin I);
- changes in left ventricular deformity (speckle tracking, strain) and reduction in LVEF;
- endothelium-dependent dysfunction of peripheral vascular beds;
- the increase in endothelial microvesicles;
- the increase in material stiffness;
- the elevation of central blood pressure.
- Conditions
- Breast Neoplasms
- Being tested
- Mitoquinone, Placebo
- Keywords
- Breast Cancer, Doxorrubicin, Mitoquinone, Cardiotoxicity, Peripheral vascular function
- Medical subject headings
- Breast Neoplasms, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitoquinoneDrug
Also called MitoQ
Mitoquinone pill, 20 mg/day
PlaceboOther
Placebo pill, 20 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Mitoquinone | Experimental | MitoQ, 20 mg per day for three months Receives: Drug: Mitoquinone |
| Placebo | Placebo comparator | Placebo, 20 mg per day for three months Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of the left ventricular deformity and reduction in left ventricular ejection fraction
Cardiac function changes (Strain and Simpson's monoplanar)
Measured: 3 Months
Secondary outcomes (5)
Systemic markers of oxidative stress
Mitochondrial oxidative stress; Cardiac markers (B-type natriuretic peptide and troponin I);
Measured: 3 Months
Endothelium-dependent dysfunction of peripheral vascular beds
changes in the endothelium-dependent function of peripheral vascular beds
Measured: 3 Months
Arterial stiffness
Increase in the arterial stiffness
Measured: 3 Months
Central blood pressure
Alterations on the central blood pressure
Measured: 3 Months
Physical capacity
Reduction in the peak oxygen uptake
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start2 Jun 2022 (estimated)
- Primary completion1 Nov 2022 (estimated)
- Study completion2 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical, randomized, double-blind, placebo-controlled trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- D'Or Institute for Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- InCor Heart Institute, Instituto do Cancer do Estado de São Paulo
- Responsible party
- Principal investigator, Allan Robson Kluser Sales, D'Or Institute for Research and Education
- Investigators
- Allan Kluser Sales, PhD, Principal investigator, D'Or Institute of Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146843
- Sponsor's protocol ID
- 48347821.8.0000.5249
- Status last verified
- Mar 2022
- First submitted
- 24 Nov 2021
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Chronic Mitochondrial Antioxidant (MitoQ) Supplementation on Cardiovascular Toxicity Induced by Doxorubicin-Based Adjuvant Chemotherapy in Breast Cancer Patients: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05146843
- Acronym / sponsor ID
- 48347821.8.0000.5249
- Conditions
- Breast Neoplasms
- Keywords
- Breast Cancer, Doxorrubicin, Mitoquinone, Cardiotoxicity, Peripheral vascular function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- D'Or Institute for Research and EducationUniversity, hospital or other
- Collaborators
- InCor Heart Institute, Instituto do Cancer do Estado de São Paulo
- Study start
- 2 Jun 2022 (estimated)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 2 Dec 2023 (estimated)
- First posted
- 7 Dec 2021 (actual)
- 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.
Investigate the protective effect of chronic MitoQ supplementation on cardiovascular toxicity induced by doxorubicin-based adjuvant chemotherapy in breast cancer patients.
Detailed description
Test the hypothesis that chronic MitoQ supplementation in breast cancer patients treated with doxorubicin prevents:
- increased mitochondrial oxidative stress;
- the increase in cardiac markers (B-type natriuretic peptide and troponin I);
- changes in left ventricular deformity (speckle tracking, strain) and reduction in LVEF;
- endothelium-dependent dysfunction of peripheral vascular beds;
- the increase in endothelial microvesicles;
- the increase in material stiffness;
- the elevation of central blood pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Clinical, randomized, double-blind, placebo-controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Mitoquinone | Experimental | Drug: MitoquinoneMitoQ, 20 mg per day for three months |
| Placebo | Placebo comparator | Other: PlaceboPlacebo, 20 mg per day for three months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients ≥18 years old, diagnosed with breast cancer (ductal, lobular and mixed carcinoma), in stage 1-3, with indication for the adjuvant AC-T therapeutic scheme, doxorubicin (60 mg/m2) plus cyclophosphamide, will be considered eligible for the study (600 mg/m2) in the regimen of 1 cycle every 21 days, followed by weekly taxane for 12 cycles.
Key exclusion criteria (1 listed)
- Patients with metastasis, severe lymphedema, renal failure, acute myocardial infarction, heart failure, stroke and chronic liver disease.
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 |
|---|---|---|
| MitoquinoneAlso: MitoQMitoquinone pill, 20 mg/day | Drug | Mitoquinone |
| PlaceboPlacebo pill, 20 mg/day | Other | Placebo |
Primary outcome
Changes of the left ventricular deformity and reduction in left ventricular ejection fraction
Time frame: 3 Months
Cardiac function changes (Strain and Simpson's monoplanar)
5 secondary outcomes
Systemic markers of oxidative stress
Time frame: 3 Months
Endothelium-dependent dysfunction of peripheral vascular beds
Time frame: 3 Months
Arterial stiffness
Time frame: 3 Months
Central blood pressure
Time frame: 3 Months
Physical capacity
Time frame: 3 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
Related trials for Breast Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Allan Kluser Sales, PhD principal investigator
D'Or Institute of Research and Education
Questions about this trial
What is this clinical trial studying?
A study testing Mitoquinone in people with Breast Neoplasms, run by D'Or Institute for Research and Education.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Allan Kluser Sales, PhD (55+21996482036, allan.sales@idor.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of the left ventricular deformity and reduction in left ventricular ejection fraction (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2022.