Breast CancerPhase 2VDDOXONCT04166253
Protective Role of Vitamin D in Breast Cancer Patients Treated With Doxorubicin
A Phase 2 study testing Vitamin D in people with Breast Cancer, run by Damanhour University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2019to 1 May 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Potential Protective Effects of Vitamin (D) Against Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients
The study is aimed at Evaluation of the potential protective effect of Vitamin D in doxorubucin- induced toxicity in breast cancer patients.
Proposal Steps:
Read more
- 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.
- 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.
Read the detailed description
Research Objectives: Evaluation of the potential protective effect of Vitamin D in doxorubucin- induced toxicity in breast cancer patients.
Proposal Steps:
- 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.)
- 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.
- 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.
- Tumor staging is done according to American joint committee on cancer (TNM staging of breast cancer eighth edition (Amin et al., 2017).
- 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.
- Echocardiography (Echo) 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.
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
- Being tested
- Vitamin D
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Also called Alfacalcidol
Alfacalcidol oral tablets once daily
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Troponin-T in ng/l
A change in plasma levels of Troponin-T in ng/l
Measured: 3 months
Vitamin D in ng/ml
A change in plasma levels of Vitamin D in ng / ml
Measured: 3 months
LDH in U/L
A change in plasma levels of LDH in U/L
Measured: 3 months
Interleukin-6 in MIU/ml
A change in plasma levels of Interleukin-6 in MIU/ ml
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start1 Sep 2019
- Primary completion1 Apr 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha El Bassiouny, Damanhour University
- Investigators
- Maged W Helmy, PhD, Study director, Professor of Pharmacology, Faculty of pharmacy, Damanhour UniversityGehan A Khedr, PhD, Study director, Assistant Professor of Oncology, Faculty of Medicine, Alexandria UniversityNoha A El Bassiouny, PhD, Study director, Lecturer of Clinical Pharmacy, Faculty of Pharmacy, Damanhour UniversityMostafa A Mahmoud, PharmD, Principal investigator, Clinical Pharmacy Specialist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166253
- Sponsor's protocol ID
- 919PP17
- Acronym
- VDDOXO
- Status last verified
- Feb 2021
- First submitted
- 11 Nov 2019
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Summary of data
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Protective Effects of Vitamin (D) Against Doxorubicin Induced Cardiotoxicity in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT04166253
- Acronym / sponsor ID
- VDDOXO / 919PP17
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 18 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is aimed at Evaluation of the potential protective effect of Vitamin D in doxorubucin- induced toxicity in breast cancer patients.
Proposal Steps:
- 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.
- 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.
Detailed description
Research Objectives: Evaluation of the potential protective effect of Vitamin D in doxorubucin- induced toxicity in breast cancer patients.
Proposal Steps:
- 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.)
- 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.
- 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.
- Tumor staging is done according to American joint committee on cancer (TNM staging of breast cancer eighth edition (Amin et al., 2017).
- 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.
- Echocardiography (Echo) 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.
Methodology:
Venous blood samples will be analyzed using ELISA Vitamin D, IL-6 kits and immuno-histo-chemistry Troponoin-T and LDH and kits.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Control group of breast cancer patients will receive adjuvant AC chemotherapy |
| Vitamin D group | Experimental | Drug: Vitamin DIntervention group of breast cancer patients will receive adjuvant AC chemotherapy in addition to vitamin D (alfacalcidol 0.5 mcg orally once daily |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DAlso: AlfacalcidolAlfacalcidol oral tablets once daily | Drug | Vitamin D group |
Primary outcome
Troponin-T in ng/l
Time frame: 3 months
A change in plasma levels of Troponin-T in ng/l
Vitamin D in ng/ml
Time frame: 3 months
A change in plasma levels of Vitamin D in ng / ml
LDH in U/L
Time frame: 3 months
A change in plasma levels of LDH in U/L
Interleukin-6 in MIU/ml
Time frame: 3 months
A change in plasma levels of Interleukin-6 in MIU/ ml
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Individual participant dataSharing planned: No. Summary of data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maged W Helmy, PhD study director
Professor of Pharmacology, Faculty of pharmacy, Damanhour University
Gehan A Khedr, PhD study director
Assistant Professor of Oncology, Faculty of Medicine, Alexandria University
Noha A El Bassiouny, PhD study director
Lecturer of Clinical Pharmacy, Faculty of Pharmacy, Damanhour University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin D in people with Breast Cancer, run by Damanhour University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Troponin-T in ng/l (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021; AzTrials last refreshed its copy on 8 Nov 2026.