Melatonin in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer
• Interventions: Drug: melatonin; Drug: Placebo

• Registration Number: NCT07067307
• Lead Sponsor: Mansoura University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study Start: 2025-07-01
• Study First Submitted: 2025-07-05
• Study First Submitted QC: 2025-07-05
• Last Update Submitted: 2025-07-05
• Study First Posted: 2025-07-16
• Last Update Posted: 2025-07-16
• Primary Completion: 2026-03
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Confirmed diagnosis with primary invasive breast cancer.
2. Patients eligible for receiving neoadjuvant chemotherapy.
3. Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2.
4. Adequate bone marrow function (white blood count ≥4,000/mm3, platelet count≥100,000/mm3), liver function (aspartate aminotransferase and alanine aminotransferase ≤ 2.5times the upper limit of normal, serum total bilirubin < 1.5 mg/dl), renal function (creatinine < 1.5 mg/dl)

Exclusion Criteria

1. Patients with metastatic or non-invasive disease.
2. Patients previously received chemotherapy within one month preceding randomization.
3. Patients who were previously taking melatonin.
4. Hypersensitivity to melatonin.
5. Patients with autoimmune diseases.
6. Pregnancy and lactation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Melatonin	melatonin	Melatonin 20 mg once daily at bedtime
Control	Placebo	Placebo once daily at bedtime

Primary Outcome Measures

Name	Time	Method
Response type to chemotherapy using Residual Cancer Burden (RCB) index.	At time of surgery after termination of neoadjuvant chemotherapy protocol	Residual Cancer Burden index (RCB) is a validated, continuous index combining primary tumor size, cellularity, and nodal metastasis either pathological complete response or presence of residual tumor ( minimal, moderate, or extensive).; The primary outcome is the difference in the mean or median RCB index between intervention and control group.

Secondary Outcome Measures

Name	Time	Method
Presence and density of Tumor Infiltrating Lymphocytes within the tumor tissue.	At time of surgery after termination of neoadjuvant chemotherapy protocol	Difference between study arms regarding presence and density of Tumor Infiltrating Lymphocytes within the tumor tissue. This will reflect tumor's biology and the immune response it elicits.
The change in radiological tumor size	At time of surgery after termination of neoadjuvant chemotherapy protocol	The change in radiological tumor size (expressed as the largest diameter) compared between both groups.; The tumor size will be obtained from standard bilateral mammography and ultrasound imaging of the breast.
Incidence and grading of myelosuppression, mucositis, and peripheral sensory neuropathy	throughout the period of neoadjuvant chemotherapy protocol (about 6 months)	Incidence of development and grading of some chemotherapy-induced toxicities (myelosuppression, mucositis, and peripheral sensory neuropathy) will be assessed using National Cancer Institute - Common Terminology Criteria for Adverse Events version 5
The proportion of patients achieving pathologic complete response (RCB-0) after neoadjuvant therapy in each group.	At surgery after completion of neoadjuvant chemotherapy.
Difference in proportions across RCB categories.	At surgery after completion of neoadjuvant therapy	Comparison of the distribution of RCB categories (0, I, II, III) between intervention and control group.; 0: No residual disease, 1: minimal residual disease, II: moderate residual disease, III: Severe residual disease.

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, Egypt