Clinical Evaluation of Melatonin Concomitant Use With Neoadjuvant Chemotherapy Protocols in Breast Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Response type to chemotherapy using Residual Cancer Burden (RCB) index.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis with primary invasive breast cancer.
- •Patients eligible for receiving neoadjuvant chemotherapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status from 0 to
- •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)
排除标准
- •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.
研究组 & 干预措施
Melatonin
Melatonin 20 mg once daily at bedtime
干预措施: melatonin (Drug)
Control
Placebo once daily at bedtime
干预措施: Placebo (Drug)
结局指标
主要结局
Response type to chemotherapy using Residual Cancer Burden (RCB) index.
时间窗: 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.
次要结局
- 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)
研究者
Mona Mohammed El-Tamalawy
Lecturer of Clinical Pharmacy
Mansoura University