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

NCT04166253 | Completed Phase 2

• 1 other identifier: 919PP17
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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:

• 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.
• Echocardiography (Echo) will be done at base line and at the end of the treatment.
• Vitamin D, LDH, Troponin-t as well as IL-6 will be assessed at baseline and at the end of the study.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (4)

• Troponin-T in ng/l

  A change in plasma levels of Troponin-T in ng/l

  3 months

• Vitamin D in ng/ml

  A change in plasma levels of Vitamin D in ng / ml

  3 months

• LDH in U/L

  A change in plasma levels of LDH in U/L

  3 months

• Interleukin-6 in MIU/ml

  A change in plasma levels of Interleukin-6 in MIU/ ml

  3 months

Study Arms (2)

Control group

NO INTERVENTION

Control group of breast cancer patients will receive adjuvant AC chemotherapy

Vitamin D group

EXPERIMENTAL

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

Drug: Vitamin D

Interventions

Vitamin D DRUG

Alfacalcidol oral tablets once daily

Also known as: Alfacalcidol

Vitamin D group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damanhour University: lead

Study Sites (1)

Damnhour university

Beheira, 22511, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Vitamin D; alfacalcidol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Maged W Helmy, PhD

  Professor of Pharmacology, Faculty of pharmacy, Damanhour University

  STUDY DIRECTOR

• Gehan A Khedr, PhD

  Assistant Professor of Oncology, Faculty of Medicine, Alexandria University

  STUDY DIRECTOR

• Noha A El Bassiouny, PhD

  Lecturer of Clinical Pharmacy, Faculty of Pharmacy, Damanhour University

  STUDY DIRECTOR

• Mostafa A Mahmoud, PharmD

  Clinical Pharmacy Specialist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant did not know the exact drug he is using.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of clinical pharmacy

Model Details: 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

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 18, 2019
• Study Start: September 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: May 1, 2020
• Last Updated: February 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)