The affects of adjuvant melatonin on the outcomes of stage III and IV non small cell lung cancer patients Cancer
Conditions
Interventions
Chronotherapeutic administration of melatonin in patients undergoing chemotherapy
Participants are randomly allocated into one of three groups:
Group 1: was placebo at 8 AM and placebo at 8 PM
Group
Sponsors
Cancer Treatment Centers of America®
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following outcome measures were collected at baseline before the administration of chemotherapy and before the administration of the third treatment cycle. 1. Sleep quality: measured using the Pittsburgh Sleep Quality Index 2. Quality of life: measured using the EORTC QLQ-C30 which measures patient functioning and symptom burden and the Ferrans and Powers QLI which measures an individual’s level of satisfaction with the human activities that give meaning and pleasure to life 3. Tumor response: was measured using the RECIST criteria 4. Circadian activity/rest cycle: measured using actigraphy devices supplied by Ambulatory Monitoring, Inc. Data was collected the week prior to treatment at the VA at baseline and three month followup; the baseline MRMC data was collected inpatient and as outpatients at the three month followup. 5. Survival data: collected on all patients until they died. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Determine what fraction of patients with advanced lung cancer suffer abnormalities of their circadian activity/rest rhythm 2. Evaluate whether the administration of exogenous melatonin will, at the appropriate circadian time, induce it’s known biological responses of lowered body temperature and sleep consolidation | — |
Countries
United States of America
Contacts
Public ContactBruce Steinert
Outcome results
None listed