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Interim Results From The First Clinical Study
James William Forsythe M.D., H.M.D is a board certified medical doctor and homeopathic physician. He was trained at the University of California San Francisco (UCSF) and completed a residency in pathology in the U.S. Army. After leaving the armed forces he completed a residency in internal medicine and became board certified in internal medicine. Following that he completed an oncology fellowship at UCSF.
Dr. Forsythe moved to Nevada 29 years ago, established a number of oncology programs in local hospitals, and ran the cancer program at the VA hospital. He is also an Associate Professor of Medicine at the University of Nevada, Reno.
Dr. Forsythe is overseeing the first clinical study of Lipoic Acid Palladium Complex as an adjuvant therapy in cancer patients.
Cancer Monthly) Doctor, how long have you worked with Lipoic Acid Palladium Complex?
Dr. Forsythe) For nearly 12 years. I had doubts about it initially, but the scientists behind it were reputable and had good credentials. Because I see a number of patients with stage IV disease (metastatic cancer), I felt that a clinical study was an order.
Keep in mind that this is a nutritional supplement, not a drug, so I decided to test it as a food supplement. I designed an outcome based protocol using this food supplement, the outcomes being survival and quality of life. Patients could either take Lipoic Acid Palladium Complex with chemotherapy or without chemotherapy.
Cancer Monthly) Can you tell us more about your study and the results so far?
Dr. Forsythe) The study began in January 2004 and we are now up to nearly 170 patients with a variety of stage IV cancers including lung, colorectal, breast, prostate, brain, renal, lymphomas, and others.
Patients were given three choices: 1) conventional treatment such as chemotherapy alone; 2) conventional treatment with Lipoic Acid Palladium Complex; 3) Lipoic Acid Palladium Complex alone. None of the patients opted for conventional treatment alone.
After nine months we had accrued 106 patients and the overall response rate was 77% which means that a little over three-quarters of the patients had either a complete response meaning that all the cancer has disappeared or a partial response meaning that 50% or more of the cancer has disappeared. These responses are being measured in the traditional way with scans (CT, MRI) and/or tumor markers.
Cancer Monthly) Do you know how the patients who just received the Lipoic Acid Palladium Complex did compared to patients who received Lipoic Acid Palladium Complex with chemotherapy?
Dr. Forsythe) The Lipoic Acid Palladium Complex alone group had an overall response rate of 42% and the group who took Lipoic Acid Palladium Complex with chemotherapy had a response rate over 77%. I have recently rerun the data at 15 months which demonstrates an overall response rate of over 60% for both groups combined.
Cancer Monthly) How do your results with Lipoic Acid Palladium Complex compare to patients who take chemo alone.
Dr. Forsythe) As an adjuvant, Lipoic Acid Palladium Complex is providing better results than what we typically see with chemotherapy alone. For patients with stage IV cancers the success rate is very limited with the conventional triad of surgery, radiation therapy and chemotherapy.
In stage IV disease we don’t do that well even with our newer drugs. Typically the best we can hope for is to sometimes prolong life a couple of years. And the toxicity of conventional treatments can be very debilitating and diminish the patient’s quality of life.
Cancer Monthly) And how has the quality of life been for patients taking the Lipoic Acid Palladium Complex alone?
Dr. Forsythe) Very good. They have none of the neutropenia, alopecia or other more debilitating side effects one usually sees with chemotherapy.
Cancer Monthly) How is the Lipoic Acid Palladium Complex administered - orally or intravenously?
Dr. Forsythe) Typically we administer a loading dose by IV for 15 days (5 days a week for 3 weeks). This is then followed by oral administration of 40 ml (8 teaspoons) a day.
Cancer Monthly) Based on your results to date what are your interim conclusions?
Dr. Forsythe) My conclusion thus far is that Lipoic Acid Palladium Complex is a safe and efficacious adjuvant to either add to chemo or to administer to patients who don’t want any further chemo or who have been through all the chemotherapy that is reasonably effective.
Cancer Monthly) Are you continuing to accrue patients?
Dr. Forsythe) Yes, if a patient wants to be part of this study they can contact my clinic at 775-827-3533 or 775-827-0707.
Source: www.cancermonthly.com
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