MelatoninNCT07349459
Cardioprotective Effect of Melatonin Versus Vitamin D in Breast Cancer Patients Receiving Doxorubicin
A study testing Group 1 (Doxorubicin group), Group 2: Vitamin D group and Group 3: melatonin group in people with Melatonin and Breast Cancer Patients Diagnosed, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to assess the cardioprotective effect of melatonin and vitamin D in breast cancer patients who receive doxorubicin. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Melatonin, Breast Cancer Patients Diagnosed, Vitamin D Concentration
- What is being tested?
- Group 1 (Doxorubicin group), Group 2: Vitamin D group and Group 3: melatonin group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2025to 30 May 2026
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 65 years old.
- Gender: female.
- Positive breast cancer women who are scheduled to receive Doxorubicin.
- Have a good performance status according to the eastern cooperative oncology group with a score of 0-2.
- Normal baseline Echocardiography with left ventricular ejection fraction ≥ 50%.
- Normal renal and liver function tests.
Who cannot join
- Pregnant or breastfeeding women.
- Women with HER-2 positive of breast cancer.
- Formerly treated with Doxorubicin.
- Patients with a known hypersensitivity to any of the used drugs.
- On other concomitant vitamins or food supplements.
- Valvular heart disease, coronary artery disease, history of congestive heart failure or cardiomyopathy.
- Impaired Left ventricular systolic function in which the Left Ventricular Ejection Fraction < 50%.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study Evaluating Cardioprotective Effect of Melatonin Versus Vitamin D in Breast Cancer Patients Receiving Doxorubicin
This study aims to assess the cardioprotective effect of melatonin and vitamin D in breast cancer patients who receive doxorubicin.
Read the detailed description
Doxorubicin is one of the most potent chemotherapeutic agents and is widely used for the treatment of various cancers and hematological malignancies . Although Doxorubicin has a potential beneficial effect in cancer treatment, its dose-dependent cardio toxicity is considered a major challenge.
Doxorubicin is known to generate free radicals either by redox cycling between a semiquinone form and a quinone form or by forming a Doxorubicin-Fe3+ complex . In both pathways, molecular oxygen is reduced to superoxide ion , which is converted to other forms of reactive oxygen species such as hydrogen peroxide and hydroxyl radical . These free radicals could then cause membrane and macromolecule damage, both of which lead to injury to the heart, an organ that has a relatively low level of antioxidant enzymes such as superoxide dismutase and catalase .
Furthermore, it was revealed that Doxorubicin may enhance the death of cardiomyocytes by affecting the tumor necrosis factor signaling pathway via increasing the expression and levels of inflammatory genes interleukin and interleukin -6 .
To alleviate DOX-induced toxicity, researchers have tested a number of strategies, including the administration of antioxidants and/or antiapoptotic agents, in both in vitro and in vivo models of Doxorubicin induced cytotoxicity, but most of these trials have failed to translate into clinical benefits . As a result, there are no effective approaches for alleviating Doxorubicin induced cytotoxicity despite intensive research over recent decades .
Melatonin is a natural hormone that is primarily secreted by the pineal gland and functions as a major regulator of circadian rhythms in humans . Melatonin also plays a variety of biological roles as a modulator of mood, sexual behavior and sleep; low levels or a deficiency of melatonin are also associated with Parkinson's disease, Alzheimer's disease, epilepsy, ischemic injury, diabetes, and even cancer .
Melatonin has emerged as a promising adjuvant that protects against doxorubicin-induced cytotoxicity, as highlighted by various studies and clinical trials that have demonstrated cardioprotective effects against several chemotherapeutic agents . Moreover, melatonin exhibits low toxicity and easily enters cells owing to its good solubility in both aqueous and organic phases and its highly lipophilic properties . Vitamin D plays an important role in the regulation of body function including the cardiovascular system .
Vitamin D deficiency results in the decrease of active calcitriol leading to inhibition of proliferation of cardiomyocytes and vascular smooth muscles .
This study aims to assess the cardioprotective effect of melatonin and vitamin D in breast cancer patients who receive doxorubicin.
- Being tested
- Group 1 (Doxorubicin group), Group 2: Vitamin D group, Group 3: melatonin group
- Keywords
- Vitamin D, Doxorubicin, Cardioprotective Effect, Melatonin, Breast Cancer Patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1 (Doxorubicin group)Drug
30 patients will receive a traditional chemotherapeutic agent (Doxorubicin group) for 12 weeks.
Group 2: Vitamin D groupDrug
patients with Vitamin D supplementation (1000 iu/day) plus traditional therapy for 12 weeks
Group 3: melatonin groupDrug
patients with 10 mg of melatonin orally, once daily plus traditional therapy for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Doxorubicin group) | Active comparator | 30 patients will receive a traditional chemotherapeutic agent (Doxorubicin group) for 12 weeks. Receives: Drug: Group 1 (Doxorubicin group) |
| Group 2 (Vitamin D group) | Experimental | patients with Vitamin D supplementation (1000 iu/day) plus Doxorubicin for 12 weeks Receives: Drug: Group 2: Vitamin D group |
| Group 3 (melatonin group) | Experimental | 30 patients with 10 mg of melatonin orally, once daily plus Doxorubicin for 12 weeks. Receives: Drug: Group 3: melatonin group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreasing incidence and severity of cardiotoxicity
Assessment of decreasing incidence and severity of cardiotoxicity by echocardiogram and ejection fraction is associated with doxorubicin treatment.
Measured: 12 weeks
Secondary outcomes (6)
Change in Plasma B-Type Natriuretic Peptide (BNP) Concentration
Change in plasma B-type natriuretic peptide (BNP) concentration from baseline to 12 weeks, measured using a chemiluminescent microparticle immunoassay (CMIA) on the Abbott Alinity i analyzer. Changes will be calculated as the 12-week concentration minus the baseline concentration and expressed in pg/mL.
Measured: Baseline and 12 weeks.
Change in N-Terminal Pro-B-Type Natriuretic Peptide (NT-proBNP) Concentration
Change in serum/plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentration from baseline to 12 weeks, measured using a chemiluminescent microparticle immunoassay (CMIA) on the Abbott Alinity i analyzer. Changes will be calculated as the 12-week concentration minus the baseline concentration and expressed in pg/mL.
Measured: Baseline and 12 weeks.
Change in High-Sensitivity Cardiac Troponin I (hs-cTnI) Concentration
Change in serum/plasma high-sensitivity cardiac troponin I (hs-cTnI) concentration from baseline to 12 weeks, measured using the Alinity i STAT High Sensitive Troponin-I chemiluminescent microparticle immunoassay (CMIA). Changes will be calculated as the 12-week concentration minus the baseline concentration and expressed in ng/L.
Measured: Baseline and 12 weeks.
Change in Myeloperoxidase (MPO) Concentration
Change in myeloperoxidase (MPO) concentration from baseline to 12 weeks, measured using a human MPO double-antibody sandwich enzyme-linked immunosorbent assay (ELISA; SunRed Biological Technology Co., Ltd.). Changes will be calculated as the 12-week concentration minus the baseline concentration and expressed in ng/mL.
Measured: Baseline and 12 weeks.
Change in Interleukin-6 (IL-6) Concentration
Change in interleukin-6 (IL-6) concentration from baseline to 12 weeks, measured using a human IL-6 double-antibody sandwich enzyme-linked immunosorbent assay (ELISA; SunRed Biological Technology Co., Ltd.). Changes will be calculated as the 12-week concentration minus the baseline concentration and expressed in ng/L.
Measured: Baseline and 12 weeks.
Change in Creatine Kinase-MB (CK-MB) Concentration
Change in serum/plasma creatine kinase-MB (CK-MB) concentration from baseline to 12 weeks, measured using the Alinity i STAT CK-MB chemiluminescent microparticle immunoassay (CMIA). Changes will be calculated as the 12-week concentration minus the baseline concentration and expressed in ng/mL.
Measured: Baseline and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Apr 2025
- Primary completion30 May 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelatoninStudies of the same condition, open and under way.
- More trials run by Tanta 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1:1 allocation ratio and sealed envelopes.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Majed Essa Alharbi, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349459
- Sponsor's protocol ID
- 36265MD408/5/25
- Status last verified
- Oct 2026
- First submitted
- 9 Jan 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be available when needed
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating Cardioprotective Effect of Melatonin Versus Vitamin D in Breast Cancer Patients Receiving Doxorubicin
- ClinicalTrials.gov ID
- NCT07349459
- Acronym / sponsor ID
- 36265MD408/5/25
- Keywords
- Vitamin D, Doxorubicin, Cardioprotective Effect, Melatonin, Breast Cancer Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 16 Jan 2026 (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.
This study aims to assess the cardioprotective effect of melatonin and vitamin D in breast cancer patients who receive doxorubicin.
Detailed description
Doxorubicin is one of the most potent chemotherapeutic agents and is widely used for the treatment of various cancers and hematological malignancies . Although Doxorubicin has a potential beneficial effect in cancer treatment, its dose-dependent cardio toxicity is considered a major challenge.
Doxorubicin is known to generate free radicals either by redox cycling between a semiquinone form and a quinone form or by forming a Doxorubicin-Fe3+ complex . In both pathways, molecular oxygen is reduced to superoxide ion , which is converted to other forms of reactive oxygen species such as hydrogen peroxide and hydroxyl radical . These free radicals could then cause membrane and macromolecule damage, both of which lead to injury to the heart, an organ that has a relatively low level of antioxidant enzymes such as superoxide dismutase and catalase .
Furthermore, it was revealed that Doxorubicin may enhance the death of cardiomyocytes by affecting the tumor necrosis factor signaling pathway via increasing the expression and levels of inflammatory genes interleukin and interleukin -6 .
To alleviate DOX-induced toxicity, researchers have tested a number of strategies, including the administration of antioxidants and/or antiapoptotic agents, in both in vitro and in vivo models of Doxorubicin induced cytotoxicity, but most of these trials have failed to translate into clinical benefits . As a result, there are no effective approaches for alleviating Doxorubicin induced cytotoxicity despite intensive research over recent decades .
Melatonin is a natural hormone that is primarily secreted by the pineal gland and functions as a major regulator of circadian rhythms in humans . Melatonin also plays a variety of biological roles as a modulator of mood, sexual behavior and sleep; low levels or a deficiency of melatonin are also associated with Parkinson's disease, Alzheimer's disease, epilepsy, ischemic injury, diabetes, and even cancer .
Melatonin has emerged as a promising adjuvant that protects against doxorubicin-induced cytotoxicity, as highlighted by various studies and clinical trials that have demonstrated cardioprotective effects against several chemotherapeutic agents . Moreover, melatonin exhibits low toxicity and easily enters cells owing to its good solubility in both aqueous and organic phases and its highly lipophilic properties . Vitamin D plays an important role in the regulation of body function including the cardiovascular system .
Vitamin D deficiency results in the decrease of active calcitriol leading to inhibition of proliferation of cardiomyocytes and vascular smooth muscles .
This study aims to assess the cardioprotective effect of melatonin and vitamin D in breast cancer patients who receive doxorubicin.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- 1:1:1 allocation ratio and sealed envelopes.
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Doxorubicin group) | Active comparator | Drug: Group 1 (Doxorubicin group)30 patients will receive a traditional chemotherapeutic agent (Doxorubicin group) for 12 weeks. |
| Group 2 (Vitamin D group) | Experimental | Drug: Group 2: Vitamin D grouppatients with Vitamin D supplementation (1000 iu/day) plus Doxorubicin for 12 weeks |
| Group 3 (melatonin group) | Experimental | Drug: Group 3: melatonin group30 patients with 10 mg of melatonin orally, once daily plus Doxorubicin for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age from 18 to 65 years old.
- Gender: female.
- Positive breast cancer women who are scheduled to receive Doxorubicin.
- Have a good performance status according to the eastern cooperative oncology group with a score of 0-2.
- Normal baseline Echocardiography with left ventricular ejection fraction ≥ 50%.
Key exclusion criteria (7 listed)
- Pregnant or breastfeeding women.
- Women with HER-2 positive of breast cancer.
- Formerly treated with Doxorubicin.
- Patients with a known hypersensitivity to any of the used drugs.
- On other concomitant vitamins or food supplements.
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 |
|---|---|---|
| Group 1 (Doxorubicin group)30 patients will receive a traditional chemotherapeutic agent (Doxorubicin group) for 12 weeks. | Drug | Group 1 (Doxorubicin group) |
| Group 2: Vitamin D grouppatients with Vitamin D supplementation (1000 iu/day) plus traditional therapy for 12 weeks | Drug | Group 2 (Vitamin D group) |
| Group 3: melatonin grouppatients with 10 mg of melatonin orally, once daily plus traditional therapy for 12 weeks | Drug | Group 3 (melatonin group) |
Primary outcome
Decreasing incidence and severity of cardiotoxicity
Time frame: 12 weeks
Assessment of decreasing incidence and severity of cardiotoxicity by echocardiogram and ejection fraction is associated with doxorubicin treatment.
6 secondary outcomes
Change in Plasma B-Type Natriuretic Peptide (BNP) Concentration
Time frame: Baseline and 12 weeks.
Change in N-Terminal Pro-B-Type Natriuretic Peptide (NT-proBNP) Concentration
Time frame: Baseline and 12 weeks.
Change in High-Sensitivity Cardiac Troponin I (hs-cTnI) Concentration
Time frame: Baseline and 12 weeks.
Change in Myeloperoxidase (MPO) Concentration
Time frame: Baseline and 12 weeks.
Change in Interleukin-6 (IL-6) Concentration
Time frame: Baseline and 12 weeks.
Change in Creatine Kinase-MB (CK-MB) Concentration
Time frame: Baseline and 12 weeks.
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 26 Oct 2026.
- Individual participant dataSharing planned: Yes. All data will be available when needed
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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 study testing Group 1 (Doxorubicin group), Group 2: Vitamin D group and Group 3: melatonin group in people with Melatonin and Breast Cancer Patients Diagnosed, run by Tanta University 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 6 inclusion and 7 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 26 Oct 2026. 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.
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?
Decreasing incidence and severity of cardiotoxicity (time frame: 12 weeks). 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 26 Oct 2026.