Clinical trial NCT04166253: Protective Role of Vitamin D in Breast Cancer Patients Treated With Doxorubicin
Official title: The Potential Protective Effects of Vitamin (D) Against Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Damanhour University
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 arms one is a control arm recieving only doxorubucin adjuvant chemotherapy and another intervention arm recieving doxorubucin as well as vitamin D orally once daily for 3 months
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: Research Objectives: Evaluation of the potential protective effect of Vitamin D in doxorubucin- induced toxicity in breast cancer patients.

Proposal Steps:

1. Assessing breast cancer patients taking part in the study receiving adjuvant chemotherapy AC (Anthracycline (Doxorubucin)-cyclophosphamide) for breast cancer for 4 cycles every 21 day (i.e. 3 months.)
2. 100 Patients 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 once daily.
3. All participants are recruited from AMUH Hospital Oncology Unit. All participants will be given their consent. The study will be approved by research ethics committee of Damanhour University.
4. Tumor staging is done according to American joint committee on cancer (TNM staging of breast cancer eighth edition (Amin et al., 2017).
5. All patients will be submitted to:

   * Full patient history and clinical examination.
   * Routine follow up before and after each chemotherapy cycle (complete blood picture, liver function tests, renal function tests.
6. Echocardiography (Echo) at base line and at the end of the treatment.
7. Vitamin D, LDH, Troponin-t as well as IL-6 will be assessed at baseline and at the end of the study.

Methodology:

Venous blood samples will be analyzed using ELISA Vitamin D, IL-6 kits and immuno-histo-chemistry Troponoin-T and LDH and kits.

Eligibility criteria: 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.

Primary outcomes:
measure: Troponin-T in ng/l
timeFrame: 3 months
measure: Vitamin D in ng/ml
timeFrame: 3 months
measure: LDH in U/L
timeFrame: 3 months
measure: Interleukin-6 in MIU/ml
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beheira
country: Egypt
facility: Damnhour university
Study officials:
affiliation: Professor of Pharmacology, Faculty of pharmacy, Damanhour University
name: Maged W Helmy, PhD
role: STUDY_DIRECTOR
affiliation: Assistant Professor of Oncology, Faculty of Medicine, Alexandria University
name: Gehan A Khedr, PhD
role: STUDY_DIRECTOR
affiliation: Lecturer of Clinical Pharmacy, Faculty of Pharmacy, Damanhour University
name: Noha A El Bassiouny, PhD
role: STUDY_DIRECTOR
affiliation: Clinical Pharmacy Specialist
name: Mostafa A Mahmoud, PharmD
role: PRINCIPAL_INVESTIGATOR
References: