Breast Cancer FemalePhase 2NCT06703593
Prevention of Doxorubicin-induced Cardiotoxicity in Breast Cancer Patients
A Phase 2 study testing Alpha lipoic acid in people with Breast Cancer Female, run by British University In Egypt at 1 site in Egypt.
Trial summary
According to the European Society of Cardiology 2022, the primary prevention of cancer therapyrelated cardiovascular toxicity during anthracycline chemotherapy include renin-angiotensin- aldosterone system blockers, beta-blockers, and mineralocorticoid receptor antagonists that have shown a significant benefit in… Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Alpha lipoic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 1 May 2025
- Phase
- Phase 2
- 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged more than 18 years
- Breast cancer diagnosis
- Entering first cycle of chemotherapy containing ATC
- Subject must be willing and able to sign an informed consent
Who cannot join
- History of renal (serum creatinine greater than 2.0 mg/ml) or hepatic insufficiency (bilirubin> 3.0 mg/dl or serum albumin < 3.5 g/dl or prothrombin time < 60% in the absence of orally administered anticoagulant therapy or ultrasound signs of chronic liver damage
- History of heart failure
- Baseline LVEF < 50% determined by transthoracic echocardiogram
- Current participation in any other clinical investigation
- History of severe adverse reaction to Alpha lipoic acid
- Concomitant use of Trastuzumab (HER2 positive patients)
Show all 10Show fewer
- Previous intake of alpha lipoic acid in the previous 3 months
- Women with prior exposure to anthracyclines and neurotoxic agents (Cis-platin, vincristine, paclitaxel, docetaxel, foscarnet, isonicotinic acid hydrazide "INH,", etc.) in the last 6 months.
- Presence of clinical evidence for severe cardiac illness (i.e., angina pectoris and arrhythmias)
- Any condition that contraindicates chemotherapy (i.e., pregnancy, lactation)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Impact of Alpha Lipoic Acid Administration on the Prevention of Doxorubicin-induced Cardiotoxicity in Breast Cancer Patients
According to the European Society of Cardiology 2022, the primary prevention of cancer therapyrelated cardiovascular toxicity during anthracycline chemotherapy include renin-angiotensin- aldosterone system blockers, beta-blockers, and mineralocorticoid receptor antagonists that have shown a significant benefit in preventing left ventricular ejection fraction (LVEF) reduction, but with no statistical differences in the incidence on the various other clinical outcomes as overt congestive heart failure (CHF). Also, other strategies have been investigated including; adjusting the infusion time and dose intensity of anthracyclines. Dexrazoxane and liposomal anthracyclines are currently approved in patients with high and very high chemotherapy-related cardiovascular disease (CTRCD) risk or who have already received high cumulative anthracyclines doses (Lyon, 2022). The incidence is about 4% when the dose of doxorubicin is 500-550 mg/m2, 18% when the dose is 551-600 mg/m2 and 36% when the dose exceeds 600 mg/m2 (Lefrak, 1973). Alpha-lipoic acid (ALA) was reported to have a cardioprotective role against doxorubicin-induced cardiotoxicity through attenuation of oxidative stress via scavenging reactive oxygen species (ROS), regenerating endogenous antioxidants including glutathione, vitamin E, and C, its metal chelation activity and its ability to repair oxidative damage. (Werida et al, 2022)
Read the detailed description
ALA effectively inhibits nuclear factor-kappa B with subsequent decreasing pro- inflammatory cytokines production (TNF-α, IL-6) and increasing the release of anti- inflammatory cytokines such as interleukin-10 (FahimehHaghighatdoostabMitraHariri, 2019).
Relying on the antioxidant and anti-inflammatory effect of Alpha lipoic acid confirmed by a variety of studies in vitro and in vivo, ALA is selected to be studied in Egyptian breast cancer patients who will be treated with doxorubicin including regimens.
Aim of the study:
The aim of the current study is to evaluate the efficacy and tolerability of ALA administration and its impact on the occurrence of doxorubicin-induced cardiotoxicity in Egyptian women with breast cancer by evaluation of the following:
- Evaluation of the occurrence of chemotherapy induced cardiotoxicity by;
- Changes in echocardiographic findings and serum levels of pro brain natriuretic peptide (pro-BNP) and cardiac troponins.
- Severity of DIC will be evaluated by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 For Heart Failure.
- Estimation of oxidative stress burden by measurement of MDA.
- Evaluation of ALA safety by:
ALA safety will be monitored and assessed through patient face to face interviews (at the end of each cycle) and phone calls weekly about the occurrence of any of the following side effects: (Ex; insomnia, fatigue, diarrhea, and skin rash).
Patients will be followed up by monitoring of the side effect reporting card (intervention arm)
- Conditions
- Breast Cancer Female
- Being tested
- Alpha lipoic acid
- Keywords
- Alpha lipoic acid, Anthracyclines induced Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha lipoic acidDrug
Also called Neuropatex, lipoic acid
ALA effectively inhibits nuclear factor-kappa B with subsequent decreasing proinflammatory cytokines production (TNF-α, IL-6) and increasing the release of anti- inflammatory cytokines such as interleukin-10 (Haghighatdoost and Hariri, 2019). Relying on the antioxidant and anti-inflammatory effect of Alpha lipoic acid confirmed by a variety of studies in vitro and in vivo, ALA is selected to be studied in Egyptian breast cancer patients who will be treated with doxorubicin including regimens.
| Study group | Role | What they receive |
|---|---|---|
| Alpha Lipoic acid intervention arm | Experimental | Alpha Lipoic acid 1200 mg daily for 6 months Receives: Drug: Alpha lipoic acid |
| No intervention arm | No intervention | not taking Alpha Lipoic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in echocardiographic findings
Elevation or maintenance of Ejection fraction percentage (EF %)
Measured: Approximately few days ( less than a week ) before Cycle 1 "baseline" and after Cycle 4 "End Cycle" of Doxorubicin. Each cycle is 21 days.
Changes in serum levels of pro brain natriuretic peptide (pro-BNP) and cardiac troponins
Decline in serum concentration of pro brain natriuretic peptide (pro-BNP) measured in picograms per milliliter (pg/mL) and cardiac troponins measured in picograms per milliliter (pg/mL).
Measured: Just before Cycle 1 "baseline" and 1 hour after Cycle 4 "End Cycle" of Doxorubicin. Each cycle is 21 days.
Secondary outcomes (1)
Changes in the oxidative stress marker malondialdehyde (MDA)
Decline in serum concentration of malondialdehyde (MDA) measured in micro mole / Litre
Measured: ust before Cycle 1 "baseline" and 1 hour after Cycle 4 "End Cycle" of Doxorubicin. 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 posted25 Nov 2024
- Study start1 Oct 2023
- Primary completion1 Apr 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Principal investigator, Alaa jamal, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703593
- Sponsor's protocol ID
- CL-2311
- Status last verified
- Sep 2023
- First submitted
- 5 Mar 2024
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Alpha Lipoic Acid Administration on the Prevention of Doxorubicin-induced Cardiotoxicity in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06703593
- Acronym / sponsor ID
- CL-2311
- Conditions
- Breast Cancer Female
- Keywords
- Alpha lipoic acid, Anthracyclines induced Cardiotoxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 25 Nov 2024 (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.
According to the European Society of Cardiology 2022, the primary prevention of cancer therapyrelated cardiovascular toxicity during anthracycline chemotherapy include renin-angiotensin- aldosterone system blockers, beta-blockers, and mineralocorticoid receptor antagonists that have shown a significant benefit in preventing left ventricular ejection fraction (LVEF) reduction, but with no statistical differences in the incidence on the various other clinical outcomes as overt congestive heart failure (CHF). Also, other strategies have been investigated including; adjusting the infusion time and dose intensity of anthracyclines. Dexrazoxane and liposomal anthracyclines are currently approved in patients with high and very high chemotherapy-related cardiovascular disease (CTRCD) risk or who have already received high cumulative anthracyclines doses (Lyon, 2022). The incidence is about 4% when the dose of doxorubicin is 500-550 mg/m2, 18% when the dose is 551-600 mg/m2 and 36% when the dose exceeds 600 mg/m2 (Lefrak, 1973). Alpha-lipoic acid (ALA) was reported to have a cardioprotective role against doxorubicin-induced cardiotoxicity through attenuation of oxidative stress via scavenging reactive oxygen species (ROS), regenerating endogenous antioxidants including glutathione, vitamin E, and C, its metal chelation activity and its ability to repair oxidative damage. (Werida et al, 2022)
Detailed description
ALA effectively inhibits nuclear factor-kappa B with subsequent decreasing pro- inflammatory cytokines production (TNF-α, IL-6) and increasing the release of anti- inflammatory cytokines such as interleukin-10 (FahimehHaghighatdoostabMitraHariri, 2019).
Relying on the antioxidant and anti-inflammatory effect of Alpha lipoic acid confirmed by a variety of studies in vitro and in vivo, ALA is selected to be studied in Egyptian breast cancer patients who will be treated with doxorubicin including regimens.
Aim of the study:
The aim of the current study is to evaluate the efficacy and tolerability of ALA administration and its impact on the occurrence of doxorubicin-induced cardiotoxicity in Egyptian women with breast cancer by evaluation of the following:
- Evaluation of the occurrence of chemotherapy induced cardiotoxicity by;
- Changes in echocardiographic findings and serum levels of pro brain natriuretic peptide (pro-BNP) and cardiac troponins.
- Severity of DIC will be evaluated by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 For Heart Failure.
- Estimation of oxidative stress burden by measurement of MDA.
- Evaluation of ALA safety by:
ALA safety will be monitored and assessed through patient face to face interviews (at the end of each cycle) and phone calls weekly about the occurrence of any of the following side effects: (Ex; insomnia, fatigue, diarrhea, and skin rash).
Patients will be followed up by monitoring of the side effect reporting card (intervention arm)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alpha Lipoic acid intervention arm | Experimental | Drug: Alpha lipoic acidAlpha Lipoic acid 1200 mg daily for 6 months |
| No intervention arm | No intervention | –not taking Alpha Lipoic acid |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women aged more than 18 years
- Breast cancer diagnosis
- Entering first cycle of chemotherapy containing ATC
- Subject must be willing and able to sign an informed consent
Key exclusion criteria (10 listed)
- History of renal (serum creatinine greater than 2.0 mg/ml) or hepatic insufficiency (bilirubin> 3.0 mg/dl or serum albumin < 3.5 g/dl or prothrombin time < 60% in the absence of orally administered anticoagulant therapy or ultrasound signs of chronic liver damage
- History of heart failure
- Baseline LVEF < 50% determined by transthoracic echocardiogram
- Current participation in any other clinical investigation
- History of severe adverse reaction to Alpha lipoic acid
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 |
|---|---|---|
| Alpha lipoic acidAlso: Neuropatex, lipoic acidALA effectively inhibits nuclear factor-kappa B with subsequent decreasing proinflammatory cytokines production (TNF-α, IL-6) and increasing the release of anti- inflammatory cytokines such as interleukin-10 (Haghighatdoost and Hariri, 2019). Relying on the antioxidant and anti-inflammatory effect of Alpha lipoic acid confirmed by a variety of studies in vitro and in vivo, ALA is selected to be studied in Egyptian breast cancer patients who will be treated with doxorubicin including regimens. | Drug | Alpha Lipoic acid intervention arm |
Primary outcome
Changes in echocardiographic findings
Time frame: Approximately few days ( less than a week ) before Cycle 1 "baseline" and after Cycle 4 "End Cycle" of Doxorubicin. Each cycle is 21 days.
Elevation or maintenance of Ejection fraction percentage (EF %)
Changes in serum levels of pro brain natriuretic peptide (pro-BNP) and cardiac troponins
Time frame: Just before Cycle 1 "baseline" and 1 hour after Cycle 4 "End Cycle" of Doxorubicin. Each cycle is 21 days.
Decline in serum concentration of pro brain natriuretic peptide (pro-BNP) measured in picograms per milliliter (pg/mL) and cardiac troponins measured in picograms per milliliter (pg/mL).
1 secondary outcome
Changes in the oxidative stress marker malondialdehyde (MDA)
Time frame: ust before Cycle 1 "baseline" and 1 hour after Cycle 4 "End Cycle" of Doxorubicin. Each cycle is 21 days.
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 1 Oct 2025.
- Individual participant dataSharing planned: No. all IPD that underlie results in a publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alpha lipoic acid in people with Breast Cancer Female, run by British University In Egypt at 1 site in Egypt.
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 4 inclusion and 10 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 1 Oct 2025. 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 Egypt. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Changes in echocardiographic findings (time frame: Approximately few days ( less than a week ) before Cycle 1 "baseline" and after Cycle 4 "End Cycle" of Doxorubicin. Each cycle is 21 days.). The study lists 2 primary outcomes in all. 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 1 Oct 2025.