Cardioprotective Effect of Melatonin Versus Vitamin D in Breast Cancer Patients Receiving Doxorubicin
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Group 1 (Doxorubicin group), Group 2: Vitamin D group, Group 3: melatonin group.
- Who it may be relevant to
- Registry conditions: Melatonin, Breast Cancer Patients Diagnosed, Vitamin D Concentration, Doxorubicin. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Study Evaluating Cardioprotective Effect of Melatonin Versus Vitamin D in Breast Cancer Patients Receiving Doxorubicin
Overview
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.
Interventions
- Drug Group 1 (Doxorubicin group)
30 patients will receive a traditional chemotherapeutic agent (Doxorubicin group) for 12 weeks. - Drug Group 2: Vitamin D group
patients with Vitamin D supplementation (1000 iu/day) plus traditional therapy for 12 weeks - Drug Group 3: melatonin group
patients with 10 mg of melatonin orally, once daily plus traditional therapy for 12 weeks
Primary outcome measures
- Decreasing incidence and severity of cardiotoxicity [Time frame: 12 weeks]
Secondary outcome measures (1)
- change in the serum level of the (biological markers). [Time frame: 12 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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%.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Tanta University — Tanta
Identifiers
NCT: NCT07349459 · 36265MD408/5/25