Melatonin in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

Official title

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

Overview

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.

Interventions

• Drug melatonin
  melatonin 20 mg tablet once daily at bedtime
• Drug Placebo
  Placebo once daily at bedtime

Primary outcome measures

• Response type to chemotherapy using Residual Cancer Burden (RCB) index. [Time frame: At time of surgery after termination of neoadjuvant chemotherapy protocol]

Secondary outcome measures (5)

• Presence and density of Tumor Infiltrating Lymphocytes within the tumor tissue. [Time frame: At time of surgery after termination of neoadjuvant chemotherapy protocol]
• The change in radiological tumor size [Time frame: At time of surgery after termination of neoadjuvant chemotherapy protocol]
• Incidence and grading of myelosuppression, mucositis, and peripheral sensory neuropathy [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. [Time frame: At surgery after completion of neoadjuvant therapy]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Mansoura University — Al Mansurah

Identifiers

NCT: NCT07067307 · 2024-104

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗