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NCT Number: NCT07067307

Melatonin in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

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.

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Mansoura University

Al Mansurah, 35516, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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.

Treatment and study plan

Melatonin

Drug

melatonin 20 mg tablet once daily at bedtime

Placebo

Drug

Placebo once daily at bedtime

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. The change in radiological tumor size

    Time frame: 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.

  3. Incidence and grading of myelosuppression, mucositis, and peripheral sensory neuropathy

    Time frame: 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

  4. The proportion of patients achieving pathologic complete response (RCB-0) after neoadjuvant therapy in each group.

    Time frame: At surgery after completion of neoadjuvant chemotherapy.

  5. Difference in proportions across RCB categories.

    Time frame: 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.

Other outcomes

  1. Adverse effects

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

    Any adverse/side effect will be evaluated

Study contacts

Contact information is provided by the study sponsor or research team.

Mona Mohammed Eltamalawy, Ph.D. in Clinical Pharmacy

CONTACT

[email protected]

+201220650700

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2025
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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