NCT07067307

Melatonin in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

Clinical Evaluation of Melatonin Concomitant Use With Neoadjuvant Chemotherapy Protocols in Breast Cancer Patients

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Melatonin is an attractive candidate with anticancer activities previously reported in various preclinical and clinical studies. Melatonin not only involves regulating biological rhythms and endocrine function but also functions in the occurrence, development, and treatment of cancer. There is a number of possible mechanisms by which melatonin may exert its anticancer effects. These mechanisms may include potent antioxidant, immunomodulating, oncostatic, antiproliferative, and estrogen-modulating properties. Regarding the immune-potentiating effects, melatonin increases the activity of lymphocytes, monocyte/ macrophage, and natural killer cells. Melatonin may also exert antiangiogenic and direct apoptotic effects. These activities, except for free-radical scavenging, are believed to be receptor-mediated through Melatonin-1 and Melatonin-2 receptors. Preclinical studies have demonstrated the antitumor effects of melatonin when used alone and enhanced effects for chemotherapy when used in combination. Melatonin has shown positive results in a number of clinical trials on patients with cancer. The effect of melatonin in early stages and locally advanced breast cancer is still questioned. Also the effect of melatonin on the development and severity of various chemotherapy-induced toxicities in breast cancer patients will be investigated.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	melatonin	melatonin 20 mg tablet once daily at bedtime
DRUG	Placebo	Placebo once daily at bedtime

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2025-07-16
• Last updated: 2025-07-16

Locations

1 site across 1 country: Egypt