3 Breast Cancer Studies

A Proposed Randomized Open-Label Study Of Enercel®In Combination With Standard Therapy Versus Standard Therapy Alone In Stage I, II And III Breast Cancer

Beat Breast Cancer Ribbon


 

 

 OVERVIEW:

     This is a randomized, open-label trial of a homeopathic formulation, Enercel®, which is to be administered IV, IM, intratumor and SL in combination with standard therapy for stage I, II and III breast cancer. The use of standard therapy alone will serve as a control. Standard therapy is defined as surgery, chemotherapy, radiation, hormonal therapy and targeted treatment (Herceptin, Avastin, Tykerb) as determined by the patient’s medical team. There will be no placebo arm due to concerns over the potential mortality of breast cancer.

    The study subjects will be voluntary, adult, female participants who meet criteria for stage I, II or III breast cancer. Prior treatment is acceptable, but any new cancer therapy within 3 months of enrollment is not allowed. Study participants will be randomized 1:1 to receive standard medical treatment alone or in combination with Enercel®. The study period will be 6 months. Study group A will receive standard medical treatment; group B will receive standard medical treatment along with Enercel® on the following schedule: 50cc IV bid for 10 days, then 2 days off repeated for 3 cycles, followed by IM 3cc daily for the duration of the study. In addition, Enercel® Max and Forte will be given 20 drops SL bid for the entire study. If there is an accessible tumor mass in the breast, Enercel® IM will be given intratumor at each visit (2 weeks). The participants will be monitored biweekly or as clinically indicated.

     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.

     Standard medical treatment will consist of surgery, chemotherapy, radiation, hormonal therapy and/or targeted therapy at the discretion of the treating physicians.

 


    2. OPEN-LABEL STUDY OF ENERCEL® IN STAGE I, II, III AND IV BREAST CANCER PATIENTS THAT HAVE FAILED STANDARD MEDICAL THERAPY

     OVERVIEW:

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

     The study subjects will be voluntary, adult, female participants who meet criteria for stage I, II, III or IV breast cancer. Prior treatment is mandatory, but there is a 1 week wash-out period prior to enrollment. Study participants will each receive a standard Enercel® treatment protocol. The study period will be 6 months.

    Enercel® will be given on the following schedule: 50cc IV bid for 10 days, then 2 days off repeated for 3 cycles, followed by IM 3cc daily for the duration of the study. In addition, Enercel® Max and Forte will be given 20 drops SL bid for the entire study. If there is an accessible tumor mass in the breast, Enercel® IM will be given intratumor at each visit (2 weeks). The participants will be monitored biweekly or as clinically indicated.

    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, chemotherapy, radiation, hormonal therapy and/or targeted therapy.

 

 

   3.  OPEN-LABEL STUDY OF ENERCEL® AS MONOTHERAPY IN TREATMENT NAÏVE VS TREATMENT EXPERIENCED LATE STAGE IV BREAST CANCER PATIENTS

Dariel Laurent MD, Sergei Mukomolov MD, David Christner MD [MA], PhD

           OVERVIEW:

     This is an open-label trial of a homeopathic formulation, Enercel®, which is to be administered intratumor, IV, IM and SL in patients with late stage IV breast cancer. There will be no placebo arm due to concerns over the potential mortality of breast cancer. Group A will have failed standard medical treatment and/or have had tumor recurrence and Group B will be treatment-naïve. Historical data will be used a controls.

     The study subjects will be voluntary, adult, female participants who meet criteria for stage IV breast cancer. Prior treatment is mandatory for group A, but there is a 1 week wash-out period prior to enrollment. Group B will be newly-diagnosed and/or treatment naïve. Study participants will each receive a standard Enercel® treatment protocol. The study period will be 6 months.

     Enercel® will be given on the following schedule: 50cc IV bid for 10 days, then 2 days off repeated for 3 cycles, followed by IM 3cc daily for the duration of the study. In addition, Enercel® Max and Forte will be given 20 drops SL bid for the entire study. If there is an accessible tumor mass in the breast, Enercel® IM will be given intratumor at each visit (2 weeks). The participants will be monitored biweekly or as clinically indicated.

     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, chemotherapy, radiation, hormonal therapy and/or targeted therapy.

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