Lung Cancer

Dariel Laurent MD, VP Dubrov MD, David Christner MD [MA], PhD

OPEN-LABEL STUDY OF ENERCEL® IN STAGE I, II, III AND IV LUNG CANCER PATIENTS THAT ARE TREATMENT NAÏVE OR HAVE FAILED STANDARD MEDICAL THERAPY

 

OVERVIEW:

     This is an open-label trial of a homeopathic formulation, Enercel®, which is to be administered intratumor, via nebulizer, IV, IM and SL for stage I, II, III and IV lung cancer. The study will use historical controls. There will be no placebo arm due to concerns over the high mortality of untreated lung cancer. Each study participant in group A will have failed standard medical treatment and/or have had tumor recurrence. Patients in group B will be treatment-naïve.

The study subjects will be voluntary, adult participants who meet criteria for stage I, II, III or IV lung cancer. Prior treatment is mandatory for group A, but there is a 2 week wash-out period prior to enrollment. Study participants will each receive a standard Enercel® treatment protocol. Group B will receive Enercel® alone. The study period will be 6 months.Enercel® will be given on the following schedule: 50cc IV bid for 20 days, then 2 days off repeated for 2 cycles, followed by IM 3cc daily for the duration of the study. In addition, Enercel® Max will be given 20 drops SL bid for the entire study. Enercel® will be used via nebulizer 2 cc twice daily. If there is a percutaneously accessible primary tumor mass in the lung, Enercel® IM will be given intratumor using sonographic/CT scan guidance at each visit (2 weeks). The participants will be monitored biweekly or as clinically indicated.

There is no standard treatment arm in this study given the preliminary effectiveness of Enercel® for cancer in case-report clinical experience coupled with poor treatment response and toxicity of standard therapy. “Study treatment failures” will be defined as two consecutive imaging studies consistent with worsening clinical status—these patients will be discontinued from the study and referred to an appropriate specialist for standard medical therapy.

Enercel® is a homeopathic formulation that has been used safely and successfully in multiple cancers. It appears to act primarily through enhancement of membrane potentials and alternate energy (ACE) pathways. It has been shown to increase Natural Killer (NK) cell function, a process that may be important in limiting cancer growth and metastases. Doses up to 50cc IV bid have been used without side-effects or toxicity.

A history of standard medical treatment consists of surgery [including surgical resection, cryotherapy, electrosurgery, laser therapy, video-assisted thoracoscopy (VAT) and brachytherapy], chemotherapy, radiation, and/or photodynamic therapy (PDT).

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