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

NCT07349459 | Not Yet Recruiting

• 1 other identifier: 36265MD408/5/25
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vitamin D Concentration; Doxorubicin; Melatonin; Breast Cancer Patients Diagnosed

Keywords

Vitamin D; Doxorubicin; Cardioprotective Effect; Melatonin; Breast Cancer Patients

Outcome Measures

Primary Outcomes (1)

• Decreasing incidence and severity of cardiotoxicity

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

  12 weeks

Secondary Outcomes (1)

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

  12 weeks

Study Arms (3)

Group 1 (Doxorubicin group)

PLACEBO COMPARATOR

30 patients will receive a traditional chemotherapeutic agent (Doxorubicin group) for 12 weeks.

Drug: Group 1 (Doxorubicin group)

Group 2 (Vitamin D group)

EXPERIMENTAL

patients with Vitamin D supplementation (1000 iu/day) plus Doxorubicin for 12 weeks

Drug: Group 2: Vitamin D group

Group 3 (melatonin group)

EXPERIMENTAL

30 patients with 10 mg of melatonin orally, once daily plus Doxorubicin for 12 weeks.

Drug: Group 3: melatonin group

Interventions

Group 2: Vitamin D group DRUG

patients with Vitamin D supplementation (1000 iu/day) plus traditional therapy for 12 weeks

Group 2 (Vitamin D group)

Group 3: melatonin group DRUG

patients with 10 mg of melatonin orally, once daily plus traditional therapy for 12 weeks

Group 3 (melatonin group)

Group 1 (Doxorubicin group) DRUG

30 patients will receive a traditional chemotherapeutic agent (Doxorubicin group) for 12 weeks.

Group 1 (Doxorubicin group)

Eligibility Criteria

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

You may qualify if:

• 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.
• Normal baseline Echocardiography with left ventricular ejection fraction ≥ 50%.
• Normal renal and liver function tests.

You may not qualify if:

• 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.
• On other concomitant vitamins or food supplements.
• Valvular heart disease, coronary artery disease, history of congestive heart failure or cardiomyopathy.
• Impaired Left ventricular systolic function in which the Left Ventricular Ejection Fraction \< 50%.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Egypt

Location

Central Study Contacts

Majed Alharbi, Resident

CONTACT

+966 55 189 8178; Ph.majed33@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 16, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: January 16, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

EG (1)