Studies

An important, beneficial action was noted on pain and appetite, as well as on nausea and vomiting. Results indicated that patients with advanced pancreatic cancer during treatment with ENERCEL^® revealed a significant improvement on selective aspects of the quality of life.

INTRODUCTION

Exocrinous pancreatic cancer has the most serious prognosis among all cancers of the gastrointestinal tract.₁ It is the seventh most common tumor in the United States and the fourth cause of death for cancer patients.₂ The quiet and rapid dissemination of the tumor of the pancreas reduces the cure rate of all patients to only 1%. ₃

The major and severe difficulties of treatment of pancreatic cancer are: firstly, when diagnosed, it has generally invaded the region to approximately 85%_3-4 and/or involved hepatic MTTS; secondly patients are very weak with anorexia, pain and weight loss. They show jaundice or hepatic dysfunction and, for that reason, the pharmacological action of drugs eliminated via bile are modified.

Though with some differences, the overall survival of pancreatic cancer patients is from three to six months (Moertel, Cubillas, Fitzgerald).₅ A significant change in the overall survival of such patients has not been observed during the past few years in spite of treatments with new cytostatic drugs and mega-voltage x-ray therapy. Any palliative treatment must be evaluated for its effect on the patients quality of life.₆

In our prospective essay, a research on selective aspects of the quality of life was included. Our hypothesis was that any positive clinical effects observed would be reflected in the subjective experience of the patient.

Our idea was that patients receiving ENERCEL^® treatment independent of treatment with cytostatic drugs and/or x-ray therapy would have a significantly smaller amount of damage to their quality of life. This group is not expected to have problems with toxicity.

PATIENTS AND METHODS: TREATMENT WITH ENERCEL^®

Compounds formed by various vegetable and mineral substances which constitute the base of the ENERCEL^® treatment were used. Mother tinctures in different alcoholic concentrations were obtained from plants. Minerals were triturated in polysaccharides through homeopathic processes to their third decimal dynamization in mills to spheres of porcelain. After the third dynamization, liquid dynamizations followed until reaching the desired dilution of alcoholic solutions in tri-distilled water. Starting from mother tinctures, we used the same process both in plants and in minerals after their fourth dynamization (i.e., after the transition from solid to liquid), employing the same solvents. Daily doses of 4 cc. were administered intramuscularly during the entire treatment. Sublingual and oral doses were also added for an additional 2.5 cc. distributed in four daily doses.

QUALITY OF LIFE EVALUATION

Evaluation of some aspects of the quality of life were made at one-month intervals using a questionnaire specifically proposed for this trial (Table 2).

Fields of Action and Contents of Items of

Questionnaire on the Quality of Life

1. Ponderal Weight:

  Did the patient lose weight?

  Did the patient remain stable?

  Did the patient gain weight?

2. Gastrointestinal Toxicity:

  Did the patient have nausea?

  Did the patient vomit?

  Did the patient lose his appetite?

3. Abdominal Pain:

  Severe?

  Moderate?

  Mild?

  No Pain?

4. Physical Activity:

  Was mobility deteriorated?

  Did the patient manage household &

  other activities?

5. Emotional State:

  Improvement?

  Stability?

  Depression?

The first questionnaire was completed by the patient or a close relative with a doctor's assistance. It was repeated monthly.

The questionnaire consisted of 15 items grouped into five categories: Ponderal Weight, Gastrointestinal Toxicity, Abdominal Pain, Physical Activity, and Emotional State. The patients marked each item, monthly, in an ordinary scale, to which a score had bee previously assigned.

RESULTS:

Eighty seven patients were eligible. From the patients studied during this period, 60 of them are still alive and continue with the ENERCEL^® treatment. Twenty-seven patients died during treatment.

Concerning Pain: It was observed that 30% of the patients underwent treatment with no pain, 48% with mild pain; 14% reported moderate pain and the remaining 9% had severe pain.

Appetite: Appetite remained stable in 57% of the cases, increased in 7% and decreased in 35% of the patients.

Ponderal Weight: In this category no significant favorable action of ENERCEL^® treatment was observed. Fifty-four percent of the patients continued to lose weight, 34% maintained their weight and only 11% increased it.

Nausea and Vomiting: An important result was observed in this category. Fifty-six percent of the patients showed no episodes of nausea and vomiting during treatment; 36% showed a noticeable reduction of symptoms and in only 7% was it possible to note an increase.

Physical Function: Assessment observed that, especially in mobility and the ambulatory function, as well as personal and family relationships, 62% of the patients showed a normal level of activity versus 38% that showed decreased activity.

Emotional State: The Emotional State was also investigated, with 8% showing improvement, 65% indicating a stable emotional state and only 26% suffering from depression.

DISCUSSION:

Our clinical evaluation indicates that the ENERCEL^® treatment significantly reduced morbidity associated with advanced pancreatic cancer.

The study was done to determine in which way the Natural Activator of the Immunological System (ENERCEL^®) has impact on the selective aspects of the quality of life. Results show a significant increase in the survival of patients treated with ENERCEL^® with respect to the figures obtained in national as well as international studies.

A significant action in pain relief was observed since 73% of the patients had no pain or only mild pain. Patients' appetites remained stable in the majority of cases.

On the other hand, it was observed that 54% of the patients continued to lose weight during the treatment.

The action of ENERCEL^® in controlling nausea and vomiting was also significantly important. When the physical and social functions as well as emotional states were assessed, emotional improvement or stability was observed, along with a physical and social activity compatible with what is considered normal, in 65% of the patients.

Due to the palliative characteristics of the ENERCEL^® treatment, great importance was given to the potential toxic effects. Physicians reported no secondary effects were noted by patients.

The questionnaire used for this study proved to be a convenient, valid and reliable measure for quality of life. It must be pointed out that the study was conducted with strict administrative management of collected data, the use of an extremely simple questionnaire completed at regular intervals and, possible most important, a high level of motivation manifested by the patients.

We conclude, completely in agreement with Dr. Lesley J. Fallowfield_7-8-9 of the London Hospital Medical College: "In the future, the medical oncologist should observe, measuring scientifically the quality of life as an essential element in the evaluation of therapies."

Cesar Bertacchini, M.D.

1. Seminars in Oncology. June, 1988. VoL XV., Suppl 4, page 56.

2. Silverberg, E. Cancer Statistics; CA 30.23. 1928.

3-4. Buncher, C.R. (ed.), Epidemiology of Pancreatic Cancer in Moossa,, AR: Tumour of the Pancreas. Baltimore, WIlliams & Wilkins, 1980, pp. 415-427.

5. Cubilla, AL, Fitzgerald, P.J.: Metastasis in Pancreatic Duct Adenocarcinoma, Day, S.B., Myers, W.P.L., Stansly, P., et. al, eds., Cancer Invasion and Metastasis: Biologic Mechanism and Therapy, pp. 81-94; New York; Raven Press, 1977.

6. Harinck, Hij, Bijouet, O.L.M., Plantiaga, A.S.T., et. al., "The Role of Bone and Kidney in Tumor Hypercalcemia and its Treatment with Biphosphonate and Sodium Chloride." American Journal of Medicine, 82: 1133-1142, 1987.

7. Clark, A. and Fallowfield, L.J. 1986, Journal of the Royal Society of Medicine., 79, pp. 165-169.

8. Fallowfield, L.J.., Baum, M and Maquirre, G.P., 1986, British Medical Journal, 22 Nov., pp.1221-1334.

9. Fallowfield, L.J.., Baum, M. and Maquirre, G.P., 1987. Journal of the Royal Society of Medicine 80. 59.