Cardioprotective Effect of Melatonin Versus Vitamin D in Breast Cancer Patients Receiving Doxorubicin

ConditionsMelatonin Breast Cancer Patients Diagnosed Vitamin D Concentration Doxorubicin

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18-65

SponsorTanta University

About this trial

This study aims to assess the cardioprotective effect of melatonin and vitamin D in breast cancer patients who receive doxorubicin.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age from 18 to 65 years old.

Gender: female.

Positive breast cancer women who are scheduled to receive Doxorubicin.

Have a good performance status according to the eastern cooperative oncology group with a score of 0-2.

Disqualifiers

Pregnant or breastfeeding women.

Women with HER-2 positive of breast cancer.

Formerly treated with Doxorubicin.

Patients with a known hypersensitivity to any of the used drugs.

Trial design

Design model

Parallel

Treatments tested in this trial

Group 1 (Doxorubicin group)
Drug
30 patients will receive a traditional chemotherapeutic agent (Doxorubicin group) for 12 weeks.
Group 2: Vitamin D group
Drug
patients with Vitamin D supplementation (1000 iu/day) plus traditional therapy for 12 weeks
Group 3: melatonin group
Drug
patients with 10 mg of melatonin orally, once daily plus traditional therapy for 12 weeks

Treatment groups

90 Participants

are divided into 3 treatment groups

Group A: Group 1 (Doxorubicin group)Placebo comparator 1 intervention

Group B: Group 2 (Vitamin D group)Experimental treatment 1 intervention

Group C: Group 3 (melatonin group)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Decreasing incidence and severity of cardiotoxicity

Assessment of decreasing incidence and severity of cardiotoxicity by echocardiogram and ejection fraction is associated with doxorubicin treatment.

Time frame

12 weeks

Secondary outcomes

change in the serum level of the (biological markers).

Time frame

12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: