Melatonin in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (5)

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

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Mansoura University — Al Mansurah

Идентификаторы

NCT: NCT07067307 · 2024-104

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗