Clinical trial · Interventional
Cardioprotective Effect of Melatonin Versus Vitamin D in Breast Cancer Patients Receiving Doxorubicin
Clinical Study Evaluating Cardioprotective Effect of Melatonin Versus Vitamin D in Breast Cancer Patients Receiving Doxorubicin
NCT07349459CI-TRIAL-00100996not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to assess the cardioprotective effect of melatonin and vitamin D in breast cancer patients who receive doxorubicin.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Patients Diagnosed | — | UNRESOLVED | — |
| Doxorubicin | — | UNRESOLVED | — |
| Melatonin | — | UNRESOLVED | — |
| Vitamin D Concentration | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Group 1 (Doxorubicin group) | Drug | — | UNRESOLVED |
| Group 2: Vitamin D group | Drug | — | UNRESOLVED |
| Group 3: melatonin group | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- PLACEBO_COMPARATOR
- label
- Group 1 (Doxorubicin group)
- description
- 30 patients will receive a traditional chemotherapeutic agent (Doxorubicin group) for 12 weeks.
- interventionNames
- Drug: Group 1 (Doxorubicin group)
- type
- EXPERIMENTAL
- label
- Group 2 (Vitamin D group)
- description
- patients with Vitamin D supplementation (1000 iu/day) plus Doxorubicin for 12 weeks
- interventionNames
- Drug: Group 2: Vitamin D group
- type
- EXPERIMENTAL
- label
- Group 3 (melatonin group)
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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%.
References
Publications (0)
Data not yet available
No reference posted for this study.