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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Mansoura University
Al Mansurah, Egypt
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.
Time frame: At time of surgery after termination of neoadjuvant chemotherapy protocol
Presence and density of Tumor Infiltrating Lymphocytes within the tumor tissue.
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.
Time frame: At time of surgery after termination of neoadjuvant chemotherapy protocol
The change in radiological tumor size
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.
Time frame: At time of surgery after termination of neoadjuvant chemotherapy protocol
Incidence and grading of myelosuppression, mucositis, and peripheral sensory neuropathy
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
Time frame: 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.
Time frame: At surgery after completion of neoadjuvant chemotherapy.
Difference in proportions across RCB categories.
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.
Time frame: At surgery after completion of neoadjuvant therapy
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