In order to investigate the anticancer effect of DDW in humans a four-month long double-blind phase 2 placebo controlled clinical trial was conducted on prostate cancer (OGYI 5621/40/95). The primary outcome was the best response, and the agent’s safety was also assessed. Forty-four patients were evaluated, 22 patients were involved in the treated-, and 22 patients in the placebo group, both groups received the same forms of conventional treatment. Summarizing the changes in prostate volume during the 4 months’ period of the trial in the treated group a net decrease of 160.3 cm3 was achieved, on the contrary, the result was 54 cm3 in the control group. During the extended follow-up of the 44 patients, in the first year (from the date of entering the trial), 2 patients (9.1%) died in the treated group and 9 patients (40.9%) in the placebo group (significantly lower mortality in the treated group; Fisher’s Exact Test, p=0.034).

In addition, beside the 44 evaluated patients in the phase 2 clinical trial, the course of the disease was also retrospectively evaluated in 91 patients consuming DDW parallel with the conventional forms of treatment. 20 out of 91 retrospectively followed patients developed distant metastasis within one year after the diagnosis. The median survival time (MST) was 5.4 year, while the historical control is 1.2-1.6 years.

The results suggest that DDW might reduce the mortality of prostate cancer, since it was able to delay progression as well as to prolong MST in patients with histologically confirmed prostate cancer.

The impact of DDW on breast cancer patients was evaluated in a retrospective study. Among the 232 patients, involved between February 1993 and April 2011, 158 had early stage breast tumor at the beginning of DDW consumption, and 74 had progressed stage tumor with distant metastasis. In the early stage breast cancer patients involved, median survival time was 217 months (18.1 years). In the subgroup where the patients started to drink DDW after the conventional therapy, in tumor-free state (in complete remission), extraordinarily good results could be achieved: median survival time was impossible to calculate because of the very low death rate during the follow-up period. In cases where the patient repeated DDW cure at least once, median survival was 293 months (24.4 years) which underlines that repeated lowering of deuterium level may play an important role also in prevention of relapse or metastasizing.

In a separate study, the effect of DDW on the survival in a patient group with distant metastatic breast cancer was analyzed. Data of 74 female patients between January 1993 and May 2005 were evaluated. All but 6 of the 74 patients had previously undergone intensive and repeated conventional therapy and their expected survival time at the beginning of the study was merely a few months. In the 74 evaluated patients 135 distant metastases were diagnosed before DDW treatment. DDW was applied in parallel with conventional cancer therapy in a supplementary manner, and the total daily water intake of the patients was covered by DDW. Simultaneous DDW and conventional treatment resulted in complete or partial reduction, or stagnation, of the tumor volume in 74.3% of the 74 patients evaluated. Median survival time from the diagnosis of the distant metastasis was 47.7 months, in contrast to 20-22 months found in literature sources. Likelihood of two-year survival of patients with distant metastases, consuming DDW simultaneously with conventional therapies, was 77.8%, while that of patients receiving only conventional therapies was 20%.

 The effect of DDW on lung tumors and on expectable survival of lung tumor patients was evaluated in a retrospective study.

From the data of the 129 patients involved, median survival increased for men from the expectable 7.5 to 25.9 months, and for women, from 11.3 to 74.1 months as a result of supplementary DDW application; while in the average for both sexes, median survival was 33.7 months. In cases of non-small cell lung cancer with brain metastasis, expectable median survival time is usually 19 to 27 months, but in our study it was 31.1 for both sexes.

Application of DDW thus prolonged the expectable median survival time of lung cancer patients 2 to 4- fold, compared to the patient population not consuming DDW. In certain cases, several years of survival or even complete remission was observed instead of the clinically expected few months. The cases of four lung cancer patients with brain metastasis who consumed DDW have been presented in our paper published in the Journal of Cancer Therapy.

References:

Z. Gyöngyi, F. Budán, I. Szabó, I. Ember, I. Kiss, K. Krempels, I. Somlyai, G. Somlyai (2012) Deuterium Depleted Water Effects on Survival of Lung Cancer Patients and Expression of Kras and Bcl2 Genes in Mouse Lung. Nutrition and Cancer, 65:2, 240-246.

K. Krempels, I. Somlyai and Gábor Somlyai (2008)  A retrospective evaluation of the effects of deuterium depleted water consumption on four patients with brain metastases from lung cancer. Integrative Cancer Therapies 7(3):172-81

 The effect of DDW on pancreatic tumors was evaluated in in vitro tests and a retrospective clinical study. In the in vitro tests, the effect of DDW was studied alone and in combination with the cytostatic Cisplatin on a Gemzar-resistant MIA PaCa-2 pancreas tumor cell line by means of the xCELLigence RTCA system (Roche Applied Sciences). This method is of advance because the cells are being monitored under physiological conditions, and cell division can be followed in real time without radioactive labelling and manipulating the cells. In the tests, changes of electric resistance are measured by means of a meshwork of microelectrodes on the bottom of the culture dish. The measured impedance increases in parallel with the growth and adhesion of the cells. This is described with the normalized cell index (CI). DDW (with 135, 125, 115, 105, 85, 65 and 40 ppm deuterium) inhibited the growth of MIA PaCa-2 pancreas tumor cells in vitro in a dose-dependent manner, with significant (p<0.02) CI decrease vs. control (150 ppm D). The cytotoxicity of Cisplatin was tested at the concentrations 20, 40 and 60 μM, combined with DDW (50 ppm D), on the MIA PaCa-2 cells. Combined application dose-dependently decreased CI, and synergism was observed. This raised the possibility that the same efficiency could be achieved with lower concentrations of the cytostatic, that is, with lower toxicity. Cisplatin showed maximum efficiency at 40 μM in presence of 50 ppm D, or already at 20 μM if 25 ppm deuterium was in the medium. This is another proof of synergism between Cisplatin and DDW in Gemzar-resistant MIA PaCa-2 cells. The results clearly show that combination of DDW and chemotherapy allows lowering the dose of cytostatics, with preserved efficiency but substantially reduced harmful side effects. In the retrospective clinical study, the survival of pancreas tumor patients was increased 6.5 times – from 6 to 39 months – by supplemental application of deuterium depletion, if DDW treatment was started within 60 days after diagnosis (n=18). In those patients (n=14) who were involved in the study more than 60 days after diagnosis, MST was 16 months.

DDW inhibited the growth of MIA PaCa-2 pancreas tumor cells in vitro. Applied together with conventional therapy, DDW prolonged MST of patients with progressive, inoperable pancreatic cancer 4-6 times.

Reference:

Boros L.G., Meuillet E.J., Somlyai I., Jancsó G., Jákli G., Krempels K., Puskás L.G., Nagy L., Molnár M., Laderoute K.R., Thompson P.A., Somlyai G. (2014) Fumarate hydratase and deuterium depletion control oncogenesis via NADPH-dependent reductive synthesis. AACR 2014 – Annual Meeting, April 5-9, San Diego, CA, USA, DOI: 10.12918/HYD2014AACRPOST