Clinical trial · Interventional
Protective Role of Vitamin D in Breast Cancer Patients Treated With Doxorubicin
The Potential Protective Effects of Vitamin (D) Against Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients
- 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)
The study is aimed at Evaluation of the potential protective effect of Vitamin D in doxorubucin- induced toxicity in breast cancer patients. Proposal Steps: 1. 100 Patients recruited from Alexandria Main University Hospital (AMUH), Oncology Unit are randomly assigned in to two groups: * Control group (n=50) the patient will receive AC regimen (Doxorubucin \& cyclophosphamide) for 4 cycles every 21 day (i.e. 3 months.) * Vitamin D group (n=50) who will receive 4 Cycles AC regimen in addition to vitamin D (Bon One 0.5 microgram®) once daily. 2. Echocardiography (Echo) will be done at base line and at the end of the treatment. 3. Vitamin D, LDH, Troponin-t as well as IL-6 will be assessed at baseline and at the end of the study.
Conditions
Conditions (1)
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 | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vitamin D | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control group
- description
- Control group of breast cancer patients will receive adjuvant AC chemotherapy
- type
- EXPERIMENTAL
- label
- Vitamin D group
- description
- Intervention group of breast cancer patients will receive adjuvant AC chemotherapy in addition to vitamin D (alfacalcidol 0.5 mcg orally once daily
- interventionNames
- Drug: Vitamin D
Primary outcomes (4)
- measure
- Troponin-T in ng/l
- timeFrame
- 3 months
- description
- A change in plasma levels of Troponin-T in ng/l
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients has a good performance status (ECOG 0-2) according to eastern cooperative oncology group (ECOG) score. * Adequate complete blood picture patients. * Females from (30-65) years of old. * Normal renal and liver functions. Exclusion criteria: * Cardiac diseased or reduced cardiac output with left ventricular ejection fraction less than 50%. * Hepatic impaired patients. * Pregnancy or breast feeding or child bearing state. * Patient with history of allergy to vitamin D. * Concomitant use of other vitamins. * Renal impaired patients. * History of breast cancer.
References
Publications (0)
Data not yet available