Protective Role of Vitamin D in Breast Cancer Patients Treated With Doxorubicin

NCT ID: NCT04166253

Last Updated: 2021-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2020-05-01

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Control group

Control group of breast cancer patients will receive adjuvant AC chemotherapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Vitamin D group

Intervention group of breast cancer patients will receive adjuvant AC chemotherapy in addition to vitamin D (alfacalcidol 0.5 mcg orally once daily

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DRUG

Alfacalcidol oral tablets once daily

Interventions

Vitamin D

Alfacalcidol oral tablets once daily

Intervention Type: DRUG

Other Intervention Names

Alfacalcidol

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Damanhour University

OTHER

Sponsor Role: lead

Responsible Party

Noha El Bassiouny

Lecturer of clinical pharmacy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maged W Helmy, PhD

Role: STUDY_DIRECTOR

Professor of Pharmacology, Faculty of pharmacy, Damanhour University

Gehan A Khedr, PhD

Role: STUDY_DIRECTOR

Assistant Professor of Oncology, Faculty of Medicine, Alexandria University

Noha A El Bassiouny, PhD

Role: STUDY_DIRECTOR

Lecturer of Clinical Pharmacy, Faculty of Pharmacy, Damanhour University

Mostafa A Mahmoud, PharmD

Role: PRINCIPAL_INVESTIGATOR

Clinical Pharmacy Specialist

Locations

Damnhour university

Beheira, , Egypt

Countries

Egypt

Other Identifiers

919PP17

Identifier Type: -

Identifier Source: org_study_id