A Multi-Center Randomized, Double-Blind, Trial Evaluating the Chronotherapeutic Role of Melatonin in the Treatment of Stage IIIB and IV Non-Small Cell Lung Carcinoma

Cancer Treatment Centers of America®0 个研究点目标入组 90 人开始时间: 2015年5月7日最近更新: 2016年10月17日

适应症

试验速览

暂无简介。

•Patients with a primary histologic diagnosis of Stage IIIB-IV non-small cell lung cancer, with either bidimensionally measurable or evaluable unresectable disease including histologically positive ascites and histologically positive pleural effusion.
•1. Patients with ECOG performance status of 0,1,2
•2. Patients who sign Informed Consent indicating that they are aware of the investigational nature of the study and the randomized study design
•3. Patients with chemo-failures from one prior regimen are acceptable
•4. Patients must agree to either:
•4.1. Comply strictly with the CTCA Nutrition 5-Pak Supplement regimen provided throughout entire course of study
•4.2. Consume no additional nutritional supplements outside of the CTCA Nutrition 5-Pak. (Clarification: Homeopathic remedies, therapeutic touch, reiki, massage and biofeedback are acceptable adjuvant natural therapies. No other biologically based therapies are allowed)
•5. In the event that patients are on melatonin prior to study, a two-week washout period will be implemented before the initiation of therapy
•6. Concurrent Radiation Therapy is allowed only for patients who initially present with an acute comorbidity requiring it (e.g. impending pathologic fracture, superior vena cava syndrome, etc.) The reason for concurrent XRT should be clearly documented

•1. Presence of any serious medical condition with which the administration of study chemotherapeutic agents is contraindicated; Inadequate renal function with serum creatinine > 2.5; Inadequate hepatic function with bilirubin > 2.0 mg/dl; Abnormal baseline MUGA of <50% ejection fraction; Uncontrolled hypertension; uncontrolled arrhythmia; uncontrolled angina; carcinomatous meningitis; uncontrolled infection; or severely abnormal PFT’s (DLCO < 60%)
•2. Primary diagnosis of any malignancy (ies) including, but not limited to: Small Cell Lung Cancer, Neuroendocrine carcinoma, sarcomas, and benign adenomas
•3. Patients with a history of brain metastases
•4. Women who are pregnant or women of childbearing potential who refuses to use prophylaxis against pregnancy while receiving chemotherapy regimens
•5. Use of beta blockers in the evening (which interferes with pineal melatonin synthesis); if patient is currently on these medications, appropriate a.m. alternatives will be implemented prior to randomization
•6. Any prior treatment failure with Cisplatin or VP16
•7. Unwillingness to comply with standard nutritional 5-pak supplement regimen and not consume any nutritional supplements outside of the nutrition 5-pak

发起方

Cancer Treatment Centers of America®