Prostate Cancer
The existing clinical data can be divided into two main groups.
Fourty-two patients belong to the group had been treated in the double blind clinical trial (first group) and almost 900 patients belong to the second group, which covers the patients who consumed the DDW before and parallel with the clinical trial.
HYD's core product, Depletin®, is under phase II clinical investigation. The clinical trial that is a double-blind, placebo controlled and of 4 months duration involved 80 patients with prostate cancer in four oncology centers in Hungary. Patients received DDW as drinking water in addition to their conventional anti-cancer medication. The primary goal of the trial was to justify the efficacy and safety of DDW in prostate cancer patients. The interim evaluation (May 1997) of the phase II study, based on data for 42 patients, showed statistically significant reduction in prostate volume of those patients ingesting DDW versus placebo treated ones. In addition, no drug-related side-effects have been observed. The completed clinical trial involved 66 patients in four oncology centers. The final evaluation has been filed at the Hungarian Institute of Pharmacy.
Abstract / Interim evaluation
August 8, 1995 a human, phase II double blind clinical trial was initiated with the aim of studying the therapeutic effect of ingestion of water with reduced deuterium content in patients with prostatic tumour. Until performing the intermediate analysis (May, 1997) 42 patients were included, in 39 of which treatment was introduced (Safety Population, SP). Four of the patients were excluded from evaluation, consequently statistical analysis was performed with 35 (Intention-to-Treat Population, ITT) and 26 (Per Protocol Population, PP).
During the nearly two years of the clinical trial no serious undesirable event attributed to the agent or other undesirable event happened.
According to the study hypothesis the ratio of patients ranged as PR in the group containing the agent should exceed by at least 30 % that of the patients ranged as PR in the control group. This hypothesis established for the primary variable was verified during the study: at the fifth or sixth visit all the proportion of patients with improving efficacy was statistically significantly greater (5th visit: p=0.0096, 6th visit: p=0.021) in the treatment group.
The change of prostatic size significantly differs between the two groups: on one hand prostatic volume decreased at the 5% level of significance in the treatment group, while score values the control group can be regarded as unchanged, on the other hand prostatic size decreased in more patients at the 5 % level of significance (Armitage Exact Test: p=0.015, Fischer Exact Test: p=0.011).
This result is confirmed by the observations regarding urination problems, when it was ascertained, that at the 1% significance level more patients had a better judgment of the changes in the symptom in the group taking the agent (Armitage Exact Test: p=0.0009, Fischer Exact Test: p=0.0018).
Examining the survival of the patients, it was ascertained, that survival of the patients belonging to the group taking the agent was significantly longer (p=0.030).
The average score values derived from the scores introduced for measuring the changes of the symptoms showed also significant differences: in the ITT-group the averages of the weighted score of the two treatment groups differred from each other at the significance level of 1% (p=0.0045). In the PP-group the averages of the weighted score of the two treatment groups significantly differred from each other at the significance level of 5% (p=0.015).
Among laboratory results significant difference was found for gamma-GT and alcalic phosphatase (ALP): in the group taking the agent decrease, in the control group increase was experienced (gamma-GT: p=0.028, ALP: p=0.022).
According to the opinion of the physicians patients taking the agent tolerated the preparation received during the clinical trial significantly (p=0.024) better.
Abstract / Final evaluation
Double blind, placebo controlled Phase II clinical trial with prostate cancer, in compliance with GCP principles confirmed a significant difference between the control and treated groups with respect to the examined parameters that indicated the anti-tumour effect of the preparation.
- At the time of the 5th and 6th visits, the ratio of patients showing an increased efficacy (PR) was significantly higher statistically (6th visit: p = 0.046) in the treated group.
- Significantly more patients reported a positive change in symptoms in the treated group (exact Armitage-test: p = 0.0014).
- The survival rate in the treated group was significantly higher (p = 0.034).
The conclusion from the results of the clinical trial can be drawn, that the decrease in the deuterium concentration in the patients organism caused by the water with reduced deuterium content (deuterium-depleted water, DDW) may be used as efficacious means in oncologic treatment.
Breast Cancer
A Retrospective Study to Evaluate the Effect of Deuterium Depletion on the Survival of Metastatic Breast Cancer Patients.
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Further Case Reports
LUNG CANCER Male patient (62); on Dd-water from 04-21-1993
(Budai MÁV Kórház, Budapest)
The condition was diagnosed in 1992; thoracotomy verified an inoperable tumor. After the diagnosis, the patient was given radiotherapy and first consumed Dd-water regularly between April 1993 and September 1993. During this time no progression could be traced. Later the patient gave up the cure because of the pain that appeared 5–10 minutes after drinking the water. Following this the patient lost 15 kg until 15 March 1994, when, on the advice of his doctor, he took up consuming Dd-water. In two months the patient gained 4 kg. According to the X-ray performed in July, the size of the tumor had not changed compared to the state observed 2 years earlier. The patient’s asphyxia stopped and he became physically active again. The examination of January 1995 verified the stagnation of the tumor, while bronchoscopy executed in June described cicatrisation in the tumor area. After this, the patient was in good physical condition and in May 1996 an X-ray scan verified regression. The patient stopped the consumption of Dd-water in good general condition in August 1996. From January 1997 a renewed deterioration followed and in May 1999 the patient complained of pain in the operation area. Physically he was active and his weight stable. Seven years have elapsed since the diagnosis and the explorative operation and according to the X-ray image, the tumor has encysted.
Male patient (72); on Dd-water from 12-05-1993
(Tüdőkórház, Deszk)
The weakened patient had a relatively small (1 cm) tumor in the upper left lobe of the lung, near the artery wall, verified by both X-ray and endoscopy. After the first month of Dd-water consumption, the tumor showed minimal growth but by January no growth could be verified. The patient, who had up till then been confined to bed, was able to get up. His physical condition improved and he was able to walk for hours. The patient had been consuming Dd-water continuously until August 1995; later, in April and October 1996 and October 1997 he repeated the cure. According to medical reports of April 1996, the tumor had encysted. Because of his hemophilia, the patient was given no conventional treatment. According to information of October 1997, the patient’s condition was stable, although 4 years earlier doctors had defined his life expectancy as only several weeks.
Male patient (47); on Dd-water from 01-10-1994
(Tüdőkórház, Deszk)
The patient had been treated from May 1993 onwards with inoperable lung cancer of an epithelial origin. Until the beginning of the Dd-water cure, the patient lost 15 kg; the size of the tumor stagnated. Later a minimal regression and, according to the December 1993 examination, progression was verified. Because of the progression, from January 1994, a change in the protocol was introduced. The patient tolerated the treatment well; his state was characterised by stagnation and an occasional decrease of atelectasia (August 1994). He received his last treatment in September 1994. The examination in December 1994, performed 3 months after the last cytostatic treatment when Dd-water was the only kind of treatment, described a “large-scale regression” that continued according to the examination results of March 1995. Progression again was detectable in January 1996; the patient died in October 1996, three and a half years after the diagnosis of the illness. He had been consuming Dd-water continuously.
Female patient (54); on Dd-water from 02-15-1994
(Tüdőkórház, Deszk)
In January 1994, the patient was diagnosed with adenocarcinoma of the lung. One month later she began to consume Dd-water and consumed it continuously for 20 months, until October 1995. During this time no progression occurred. In June 1995 the tumor that had earlier been verified as being of the size of a man’s fist became smaller. The patient was in good general condition when she stopped drinking Dd-water. According to our information of September 1998, four and a half years after the diagnosis with lung adenocarcinoma, she was active and working. The tumor had for years been stagnating after the consumption of Dd-water.
Female patient (46); on Dd-water from 09-29-1994
(SOTE Pulmonológiai Klinika, Budapest)
In March 1994, a 4 x 5 cm tumor and one 8 cm in size, of a mixed histological type (planocellular + anaplastic adenocarcinoma) was diagnosed. The beginning of the Dd-water cure coincided with a change in the protocol, thus the 50 percent decrease in the volume of the tumor experienced two weeks later can be attributed to the joint effect of the two kinds of treatment. Cytostatic treatment ended in February 1995. By March the patient had no more asphyxiation, her general condition was good, and by June she gained 12-14 kg of body weight. A renewed progression was verified in August; the patient died in March 1996, two years after the diagnosis.
Female patient (61); on Dd-water from 11-29-1994
(Tüdőkórház, Deszk)
The patientwas diagnosed with microcellular lung cancer in September 1994; cytostatic treatment began in October. The patient reacted well but tolerated the grave side-effects with difficulty. She had been consuming Dd-water continuously from November 1994 until October 1995; her physical state was satisfactory. She did not show up after this, but from another patient treated in the same hospital we know that she died four years after the diagnosis and 3 years after finishing the Dd-water cure.
Female patient (75); on Dd-water from 04-18-1995
(Országos Korányi TBC és Pulmonológiai Intézet, Budapest)
The patient was operated on in August 1993 with adenocarcinoma. The tumor was attached to the wall pleura in the apex. In the centre of segment III, a tumor the size of a walnut was found. This and the hilar lymphatic nodes were removed by lobotomy. The Ca 19-9 tumor marker value of the patient increased from the end of 1994:
November 1994: 54.8 ng/ml
January 1995: 54.3 ng/ml
February 1995: 74.9 ng/ml
In the first three months of consuming Dd-water the patient lost 5 kg, and the tumor marker further increased.
July 1995: 86.1 ng/ml
After the increase of the Dd-water dose, from December 1995 the tumor marker values were as follows:
December 1995: 60.8 ng/ml
March 1996: 45.4 ng/ml
October 1996: 39.4 ng/ml
January 1997: 29.6 ng/ml
June 1997: 23.5 ng/ml
January 1998: 20.2 ng/ml
The patient has been consuming Dd-water for the fifth year; lives in good physical condition and without complaints six years after the operation.
Male patient (69); on Dd-water from 10-10-1995
(Szt. Ferenc Kórház, Miskolc)
In June 1994 a left side pulmonary neoplasia was verified (planocellular), which, during exploration, proved to be inoperable. The tumor infiltrated the pericardium and entwined the main arteries. Because of the size and location of the tumor, conventional treatment had to be rejected; thus, Dd-water was the only means of treating the patient. After a six month Dd-water cure, by April 1996 the patient noted improvement in his health. ESR fell from 80 to 6, the size of the tumor stagnated. The blood sugar level of the diabetic patient decreased, his dyspnoea lessened, the accumulated residues cleared up from the left lung, and the patient was able to return to his work as a physician. In the fall of 1997, the patient felt well enough to undertake a journey abroad. His state was stable until June 1998, when a slow tumor growth was observed. In July 1998 the patient underwent a myocardial infarction and had dyspnea even at rest. Heart complaints were stabilized with medication, and his tumor showed minimal growth only, despite the fact that following the heart attack he stopped the consumption of Dd-water, and restarted in January 1999 only. In June 1999 the patient had no dyspnea when resting and X-ray showed a moderate progression. He has been consuming Dd-water for 4 years now, with only one break in the meantime. The patient regularly coughs up a considerable amount of secretion.
Note: With regard to the frequent occurrence of lung cancer, we have described several cases. It is clear from the above that we were able to provide positive examples to demonstrate all types of lung cancers. If we were to make a statistical summary, we would see that in 60–70 percent of the cases there was an objective reaction after the consumption of Dd-water; survival rates increased significantly and the tumor could, for years, remain dormant. The case of the 75-year-old patient illustrates well that in remission following surgery, Dd-water can prevent later recurrence, which would supposedly have happened taking tumor marker values into consideration. Results can significantly be improved by beginning the treatment with 75–85-ppm Dd-water instead of 90-ppm water. This is justified especially in the case of large (4–5 cm) tumors.
MELANOMA MALIGNUM Male patient (51); on Dd-water from 11-17-1994
(SOTE Bőrklinika, Budapest)
In July 1994, the patient had a Clark III melanoma removed. The tumor started from a mole on the left side of the abdomen. In August of the same year block dissection was performed in the left armpit. Following this, the patient was given DTIC and Interferon treatment. He had been consuming Dd-water regularly since the above date and was symptom-free in 1995, 1996, and 1997. During this time a single operation was performed when, in May 1996, a lymphatic node that had been in the armpit for one and a half years but showed no growth was removed. The microscopic description of the removed node contains the following: “… the bulk of the substance is occupied by tumor tissue forming contiguous fields… Frequent dividing formations. Necroses in the substance of the tumor. The tumor is surrounded by a thick fibrous case; the excision does not reveal the extension of the tumor into the adipose tissue.”
With regard to the long symptom-free period, we suggested a break in consuming Dd-water after more than 3 years, from the beginning of 1998. One and a half months after the suspension of the consumption of Dd-water, a lump appeared on the breast of the patient, after which he died without having consumed Dd-water, in March 1999.
Male patient (46); on Dd-water from 12-20-1994
(Országos Onkológiai Intézet, Budapest)
The patient had first been operated on with melanoma malignum. Later, in April 1992, lymphatic nodes were removed from the armpit, followed by further surgery and DTIC treatment in the spring of 1994. By the fall, metastases appeared behind the ear and also in the liver; this was followed by Intron A treatment. According to the CT scan made one month after the start of the Dd-water cure, two earlier liver metastases could not be verified, two became smaller and one remained unchanged. Further examinations (March, June, December 1996; February, December 1998) described gradual regression of the liver metastases, while, according to the April 1999 CT scan: “The formerly described small residual lesions are not traceable. Unanimously circumscribed formation is not verifiable by CT scanning.” The patient has, since the verification of liver metastases, for the fifth year been active and working.
Note: We wish to stress that despite the two successful examples mentioned above, melanoma belongs to the type of tumors that react very poorly and can be treated with great difficulty only. We could not achieve any success in cases when newer metastases appeared weekly. This observation of ours is in accordance with the in vitro examinations of the American laboratory, according to which the melanoma cell line got adapted to the culture medium of lower D-content within 6 hours, while with prostate and breast cell lines inhibition was traceable for 24–48 hours. Thus, from the aspect of dosage, in the case of this tumor type the dose must be increased, i.e. D-level decreased in the body, within a time shorter than usual.
OVARIES Female patient (45); on Dd-water from 02-1993
(Szt. István Kórház, Budapest)
The patient was operated on with tumor of the ovary in 1993. Following surgery, her tests were negative; she had a good appetite, gained 4 kg and was active and working. She had been consuming Dd-water continuously between February 1993 and November 1994, when, with regard to the long symptom-free period, she stopped the cure. Results of examinations in December 1994 were negative, but two months later complaints in the abdomen appeared. In February 1995, a repeated operation took place. After this the patient resumed the consumption of Dd-water. It is to this that we attribute that, despite the positive cytological result, sonography turned out to be negative again. In April 1996 recidiva could be verified. The patient died in November 1997 after a long struggle, nearly three years after the first relapse. (After this, we did not recommend to other patients tumor of the ovary to stop drinking Dd-water even after a post-operative two-year-long symptom-free period.)
Female patient (52); on Dd-water from 04-04-1996
Péterfy Sándor Utcai Kórház, Budapest)
The patient was diagnosed with tumor of the ovary in the summer of 1995 which, histologically, proved to be a highly differentiated adenocarcinoma. The uterus and the omentum were also affected. After surgery the patient was given a series of 8 cytostatic treatments (Carboplatin, Cysplatin) that ended in March 1996. She began to consume Dd-water after the completion of conventional treatment and has been drinking it for 40 months continuously – she is active and symptom-free.
Note: It is a well-known fact that patients with ovarian tumors have a very poor prognosis. In spite of this, however, according to our experience it can be well treated with D-depletion. We would like to stress that between prognoses based on our present knowledge and the efficacy of Dd-water there is no strict correlation. This means that tumor types that seem hopeless from the traditional point of view may react well to Dd-water treatment. In the case of tumors of the ovary we wish to highlight that in some cases a relapse may occur even after remission for several years if the patient stops consuming Dd-water.
PROSTATE Male patient (65); on Dd-water from 10-30-1992
(Dél-pesti Kórház)
The patient was diagnosed with inoperable prostate tumor in October 1992. After the beginning of the cure he noted an improvement in urination problems and the PSA value decreased even prior to the start of the Fugerel treatment. After one month the tumor became impalpable and also operable, but the patient (a physician by profession) refused to undergo surgery. After drinking Dd-water for a year, the patient has been free of complaints for seven years.
Male patient (66); on Dd-water from 12-01-1994
(Szeged, MJVÖ Kórháza)
In September 1994 the tumor of the prostate caused total obstruction and metastases in the lymphatic glands. In October the PSA value was 83.4 ng/ml. Following Dd-water consumption,urination problems stopped within a short time. Two weeks after the start of the Dd-water cure, blood samples revealed a 0.99 ng/ml PSA value. This, however, was thought to be erroneous, therefore two weeks later it was repeated, and showed a value of 0.6 ng/ml. This value decreased by March 1995 to 0.23 ng/ml, whereas values measured in June 1996 and January 1997 were below the traceable level. The patient had, for the first time, been drinking Dd-water continuously for 9 months, and repeated the cure for 2–3 months in 1996.
Note: In the case of prostate tumor it is of great significance that by measuring PSA value, the potentially tumorous patient population can be defined. Based on our results so far, we are of the opinion that if we are able to diagnose the illness in its early phase, with the application of Dd-water this tumor type can be cured with great efficacy without the need for drug treatment throughout the patient’s whole life. It would be of great economic significance to test the male population above 50–60 for PSA value and to treat cancer patients with Dd-water. For the time being, the cheap test (some thousand forints/test) is followed by very expensive treatment (approx. USD 2000-3000/year/patient) which, in the majority of cases lasts throughout the entire life of the patient. Not even the United States of America can afford to provide preventive treatment for all men with tumor of the prostate, as this would cost about 100 billion dollars. The application of Dd-water would make the treatment followed by cheap scanning accessible to everyone.
COLON, RECTUM
Female patient (55); on Dd-water from 11-03-1993
(Honvéd Kórház, Győr)
Sonography conducted in October 1993 verified 5 liver metastases originating from the tumor of the rectum. The patient complained of severe pain in the liver area, which stopped within days after Dd-water consumption. In February 1994, the patient, who had not been consuming Dd-water for a week, reported a reappearance of pain which stopped again after the renewed consumption of Dd-water. The patient’s state was stable and she was active during 1994 and in early 1995. She stopped consuming Dd-water in March 1995, and died in July 1995, 21 months after the verification of metastases in the liver.
Male patient (65); on Dd-water from 10-10-1994
(BM Kórház, Budapest)
In September 1994, originating from a colon tumor, a 3–6 cm multiplex metastasis was verified in the liver. Tumor marker values were measured immediately before the beginning of Dd-water consumption (10-06-1994), then four months later (02-20-1995). The values were as follows:
CEA: 959 ng/ml 189.7 ng/ml
CA-50: 998 U/ml 195.8 U/ml
Ca-242: 3069 U/ml 324.6 U/ml
The patient had been consuming Dd-water until his death in July 1996. The patient survived 22 months after the diagnosis in September 1994.
Male patient (58); on Dd-water from 02-07-1995
(Országos Onkológiai Intézet, Budapest) In February 1995, a 60-cm section of the colon was removed in surgery. In the liver, 5–6 metastases were found, one of which was the size of an apple. The patient was given 5FU + Leukovorin treatment. According to an examination in March – after the consumption of Dd-water for a month – the two kidney cysts were not detectable and by May the patient had gained 6 kg. CT and sonography in October verified stagnation and the presence of calcified spots in the liver. CT scan conducted in August 1996 also verified stagnation. From October occasional diarrhea occurred, followed by significant deterioration in health. The patient died in May 1997, 27 months after the diagnosis of the illness and the appearance of metastases in the liver.
Note: With this tumor type, in the case of distant metastases we “only” succeeded in significantly enhancing survival. This tumor type reacts to deuterium depletion very slowly, and 90-ppm Dd-water was not of a sufficiently low D-content to be able to eliminate larger metastases in the liver. It would be of great significance if the patient consumed Dd-water continuously for 1–1.5 years after colon-rectum surgery, as a cure could prevent the appearance of distant metastases. With this tumor type and in the presence of distant metastases, it is advisable to start Dd-water treatment with water of 75–62.5 ppm D-content.
TONGUE, PERISTOME Female patient (56); on Dd-water from 07-12-1992
(SZAOTE Fül-Orr-Gégészeti Klinika, Szeged)
The patient underwent the first surgery in March 1989 with a tumor of the tongue which had been present for a year. In 1990, the tumor receded and the patient was given repeated treatment. At the end of 1992, a relapse occurred again and it was then that the patient began to consume Dd-water. From that time on, the size of the tumor decreased, and biopsy performed in March 1993 did not verify tumorous tissue in the sample. The patient had been consuming Dd-water continuously during the year 1993, and made a break in January 1994. Subsequently there was a significant progression of the illness, and another operation became necessary in August 1994. Dd-water consumption was regular from June 1994 on. In February 1997, another biopsy was performed which again proved to be positive. By increasing the Dd-water dose, the size of the newly appeared nodes decreased, and their texture became softer. A more significant progression was experienced in the spring of 1998 only, when X-ray verified lung metastasis. Due to the increased dose the patient coughed up slimy secretions, the tumor in her mouth got softer, the size of the tumor near the esophagus decreased, and the tumor at the ear was no longer sensitive. The patient survived another year, and died in the spring of 1999. Ten years had elapsed since the first operation. In the first three years, prior to Dd-water consumption, there were three relapses. We suppose that by a continuous Dd-water consumption, relapses of such an extent would not have occurred. The next case serves as a good example of the above.
The patient underwent the first surgery in March 1989 with a tumor of the tongue which had been present for a year. In 1990, the tumor receded and the patient was given repeated treatment. At the end of 1992, a relapse occurred again and it was then that the patient began to consume Dd-water. From that time on,The patient had been consuming Dd-water continuously during the year 1993, and made a break in January 1994. Subsequently there was a significant progression of the illness, and another operation became necessary in August 1994. Dd-water consumption was regular from June 1994 on. In February 1997, another biopsy was performed which again proved to be positive. By increasing the Dd-water dose, the size of the newly appeared nodes decreased, and their texture became softer. A more significant progression was experienced in the spring of 1998 only, when X-ray verified lung metastasis. The patient survived another year, and died in the spring of 1999. Ten years had elapsed since the first operation. In the first three years, prior to Dd-water consumption, there were three relapses. We suppose that by a continuous Dd-water consumption, relapses of such an extent would not have occurred. The next case serves as a good example of the above.
Female patient (63); on Dd-water from 07-13-1993
(Országos Onkológiai Intézet, Budapest)
The patient had received three operations before June 1993 with renewed tumors of the oral cavity. Then, as the patient refused to consent to the partial elimination of the jaw, she was given a full dose of radiation. At that time she began to drink Dd-water. By August 1993 the wound under the tongue had healed, the tumor on the chin softened and by September the tumor on the neck disappeared. From a medical point of view the years 1994, 1995, 1996, and the first nine months of 1997 went by uneventfully. Then a wound made by an apricot pit would not heal. The patient was given two cytostatic treatments in November 1997, and the third was skipped because the wound had by then healed completely. The patient, by sustaining her good quality of life is in excellent physical condition and has been consuming Dd-water for the sixth year.
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