Melatonin in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

NCT07067307 | Not Yet Recruiting Phase 1

• 1 other identifier: 2024-104
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

melatonion; chemotherapy induced toxicity

Outcome Measures

Primary Outcomes (1)

• Response type to chemotherapy using Residual Cancer Burden (RCB) index.

  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.

  At time of surgery after termination of neoadjuvant chemotherapy protocol

Secondary Outcomes (5)

• Presence and density of Tumor Infiltrating Lymphocytes within the tumor tissue.

  At time of surgery after termination of neoadjuvant chemotherapy protocol

• The change in radiological tumor size

  At time of surgery after termination of neoadjuvant chemotherapy protocol

• Incidence and grading of myelosuppression, mucositis, and peripheral sensory neuropathy

  throughout the period of neoadjuvant chemotherapy protocol (about 6 months)

• 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

Other Outcomes (1)

• Adverse effects

  throughout the period of neoadjuvant chemotherapy protocol (about 6 months)

Study Arms (2)

Melatonin

ACTIVE COMPARATOR

Melatonin 20 mg once daily at bedtime

Drug: melatonin

Control

PLACEBO COMPARATOR

Placebo once daily at bedtime

Drug: Placebo

Interventions

melatonin DRUG

melatonin 20 mg tablet once daily at bedtime

Melatonin

Placebo DRUG

Placebo once daily at bedtime

Control

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis with primary invasive breast cancer.
• Patients eligible for receiving neoadjuvant chemotherapy.
• Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2.
• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Mona Mohammed Eltamalawy, Ph.D. in Clinical Pharmacy

CONTACT

+201220650700; mona.m.eltamalawy@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Clinical Pharmacy

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: July 16, 2025
• Study Start: July 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

EG (1)