The survival and quality of life benefits of melatonin when administered to cancer patients at the optimal time of day
- Conditions
- The affects of adjuvant melatonin on the outcomes of stage III and IV non small cell lung cancer patientsCancer
- Registration Number
- ISRCTN16419921
- Lead Sponsor
- Cancer Treatment Centers of America®
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 90
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method