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Pro-Stat^® Indications for Use

Pro-Stat® has been shown to be effective in the treatment of the body- wasting (cachexia) among patients with advanced cancer.

The following narrative details the indications, objective, protocol and results of a study conducted on advanced cancer patients at Whitestone General Hospital in New York.

USE OF EMF (now known as Pro-Stat®) AS AN ADJUNCT TO TREATMENT OF PATIENTS WITH ADVANCED CANCER

In patients with illness serious enough to cause hospitalization, loss of appetite, anorexia and the resulting deficit diet produce loss of body protein mass. A major goal in nutritional therapy is directed at preservation and restoration of body cell mass. The key nutrient assuming this function is protein. To ensure proper utilization of protein, adequate co-factors including fluid, electrolytes, vitamins and minerals are required plus a physiological state that will allow the majority of energy requirements to come from non-protein sources (i.e. diet or stored glycogen and/or fat). Once this caloric requirement is met, 100 grams of protein/day is required to obtain optimal nitrogen balance. The provision of this protein orally produces a good utilization by the liver and other visceral tissues in sustaining required new protein for host defense and survival.

Pro-Stat® is a concentrated source of hydrolyzed protein of unique value in illness, and represents an important feeding module for the nutritional support of hospitalized patients. Criteria for efficacy go beyond nitrogen balance and include impact on immune function, secretary protein, acute phase protein response, tissue repair and morbidity and mortality. Hydrolyzed collagen and equivalent amino acid profiles have also been used with success in helping maintain the nutritional state of chronically debilitated patients, and patients receiving cancer chemotherapy and radiation therapy.

The advanced cancer patient is frequently one who is nutritionally depleted and exhibits severe body wasting. This body wasting, referred to as cachexia, is often associated with anorexia. The task at hand seems to be getting the patient to eat. Getting the patient to gain weight and stop the weight loss and hopefully let surgery, chemotherapy and radiotherapy do the remainder of the job. But first, and foremost, we must increase the weight and improve the nutritional status of the patient.

EMF, (now known as Pro-Stat®), a predigested protein, which has safety, ease of administration, efficiency, patient ease of accessibility and low cost was studied at Whitestone General Hospital in New York for 25 advanced cancer patients.

It is generally recognized that cancer chemotherapy cannot be tolerated as well, or as long, without proper nutrition. Proper nutrition is difficult to achieve using normal or conventional diet therapy. Supplemental nutrition such as naso-gastric tube feelings and intravenous hyperalimintation are effective short-term force-feeding regimens. This study seems to indicate that use of a concentrated fortified collagen together with adequate calories and interested dietary management is a worthwhile adjunct in the nutritional support of the advanced cancer patient.

Hi-protein formulas have been used to build up nutritionally deficient, appetite poor patients; however, the exceedingly high quantity of nitrogen in such diets may tax the hepatic and renal systems. Therefore, a supplement, which contains all the elements of a hi-protein formula and which is absorbed without taxing the liver or kidney, was explored.

One specific area for use of such a supplement would be with advanced cancer patients, where extreme weight loss and loss of appetite is prevalent.

EMF (Pro-Stat®) is a Liquid Predigested Protein, 30mL of which exhibit the following makeup:

TYPICAL AMINO ACID PROFILE
g / 100g Protein

EMF (Pro-Stat®) is derived by hydrolyzing the collagen.

OBJECTIVE
The purpose of this study is to evaluate EMF (Pro-Stat®) in patients with cancer.

CRITERIA
Patients with all types of cancer who exhibit the following criteria will be accepted for entrance into the study.
1. Severe weight loss (Greater than losses equaling 10% of normal body weight according to height-weight charts.)
2. Severe loss of appetite (Under 1000 calories per day)
3. Fatigue
4. Depression
5. On systemic cancer therapy

STUDY DESIGN (IN-PATIENTS)

1. 2 oz. of EMF (Pro-Stat®) protein is given to patients 3 times a day, once at each meal.
2. Patient's intake is recorded for protein, carbohydrate, fat, and calories daily.
3. Weight changes are recorded daily.
4. Complete blood and platelet count are done every other day.
5. SMA-12s are done weekly.
6. Patients are tested on a monthly basis by use of the Clyde Mood Scale.

STUDY DESIGN (OUT-PATIENTS)

1. 2 oz. of EMF (Pro-Stat®) protein is given to patients 3 times a day, once at each meal.
2. Patients will be seen on a weekly basis for evaluation of eating habits and energy levels.
3. Weights will be recorded weekly.
4. Blood counts and SMA-12s will be done weekly.
5. Patients are tested on a monthly basis by use of the Clyde Mood Scale.

The study is to be continued unless there is objective evidence that the patient-cannot tolerate EMF (Pro-Stat®)or becomes unwilling.

NUMBER OF PATIENTS AND DURATION OF STUDY
25 patients or more will be studied in a 3-month period.

NAME AND ADDRESS OF PHYSICIAN.
Donald R. Cole., M.D. I.
Whitestone General Hospital
10-01 166th Street
Whitestone, NY, 11357

NAME AND ADDRESS OF DIETITIAN
Sandford Schwartz, R.D. 
Whitestone General Hospital
10-01 166th Street
Whitestone, NY, 11357

DIETARY MANAGEMENT OF ADVANCED CANCER PATIENTS UNDERGOING TREATMENT: A PRELIMINARY REPORT
I. S. Schwartz, R.D.

High protein formulas, which contain 25% protein, have been used to build up nutritionally deficient, appetite poor patients. Twenty- five patients with metastatic cancer were studied, exhibiting the following criteria: 1) weight loss (greater than losses equaling 1% of the normal body weight according to the height/weight charts; 2) loss of appetite, generally consuming less than 1000 calories a day; 3) fatigue; 4) depression; and 5) receiving systemic cancer chemotherapy. Hospitalized patients were given the following: a normal meal consisting of a regular diet (unless contraindicated, such as low fat, diabetic, consistency changes). In addition they were given 2 oz. of EMF(Pro-Stat®), which was 30 grams of predigested, fortified collagen protein 3 times a day with each meal. The EMF(Pro-Stat®) was cherry flavored and mixed as a syrup with club soda, water, milk, or consumed straight. Weight, calorie count including protein, carbohydrate and fat were measured on a daily basis. Complete blood and platelet counts were done every other day. SMA 12s were done every week. Patients were visited 2 to 3 times daily by a member of the research team to insure optimal acceptability of the diet and to gain patients' participation in their nutritional support. Everything was done to make the patient as comfortable as possible in the hospital and to increase their food consumption.

When patients were discharged they were continued on EMF (Pro-Stat®), as in the hospital. They were seen weekly for evaluation of eating habits and energy levels. Weights were recorded weekly. Blood counts and SMA12s were done weekly and patients were then tested on the Clyde Mood Scale on a. monthly basis. 

Of the 25 patients selected, most of the patients continued on the protein study for the full 3 months and have continued. Of these 25 patients on the study, 24 were able to take EMF for a minimum of at least 50 days. The figure insert shows the EMF (Pro-Stat®) nitrogen to calorie ratio effect on weight gain and that increased calorie intake was best in producing weight gain. 

It is generally recognized that cancer chemotherapy cannot be tolerated as well, or as long, without proper nutrition. Proper nutrition is difficult to achieve using normal or conventional diet therapy. Supplemental nutrition such as naso-gastric tube feedings and intravenous hyperalimintation are effective short term force feeding regimens. This study seems to indicate that use of a concentrated fortified animal collagen together with adequate calories and interested dietary management is a worthwhile adjunct in the nutritional support of the advanced cancer patient. Future studies are planned to further delineate the results of this study.

Nov. 1978

DIETARY MANAGEMENT OF ADVANCED CANCER PATIENTS UNDERGOING TREATMENT: A PRELIMINARY REPORT
D. Cole M.D.

The advanced cancer patient is frequently one who is nutritionally depleted and exhibits severe body wasting. This body wasting referred to as Cachexia is often associated with anorexia, and an increased basal metabolic rate. Although the method by which this occurs is not always understood, many feel that this body wasting is due in the majority to the use of host proteins by the tumor. One theory suggests that the tumor and its host, the cancer patient, compete for available nutrients and the tumor wins out in some cachexic patient. That simple explanation is not accepted by most, nor is an alternate idea that the cancer patient simply stops eating. Although many factors must be involved, few researchers have looked further into the tumor competition question to our knowledge. In an address of the National Cancer Institute, Dr. S. Morrison said: There is no convincing evidence in animals of a raised total metabolism of the host. There has been continuing controversy on the extent to which the wasting is attributable to reduced food intake, or increased metabolic rate of the host, or a preemption of available nutrients for general growth, and maintenance of the tumor, and irreversible demand by the tumor for specific essential nutrients. In terms of energy and overall nitrogen exchange and probably in  terms of most specific nutrients, this controversy is largely empty. It does not matter very much whether absolute intake goes down, or absolute cost goes up. What is important is that in every instance, supply progressively fails to meet the need. Many patients begin losing weight even before their tumor is diagnosed. Often weight is the symptom that leads the patient to a physician. The pre-diagnostic weight loss may not be united to host or nutrient com- petition, instead, some patients have already stopped eating normally without realizing it. In certain instances without knowing why, a problem which became more severe as the disease progressed. Here the problem may be physiological not behavioral. The tumor growth rate seems to be critical too. It has been demonstrated that as a tumor regressed, or after it is excised, eating patterns frequently normalize. Dr. S. Dudrick from the University of Texas, suggests that tumors may excrete a substance which circulates through the body and effects the taste buds, causing the cancer patient to reduce food intake before realizing it. The same patients who complain of bitter taste to food frequently develop a distaste for meat. A substitution of other protein has been suggested. The distaste seemed to run in a range, the most frequent for beef and then pork. Poultry, fish, cheese and eggs are substitutes for more debilitated patients. There is considerable discussion over how much a patient's food intake could be increased using this knowledge and applying behavior modification techniques.

The task at hand seems to be getting the patient to eat. Getting the patient to gain weight and stop the weight loss and hopefully let surgery, chemotherapy and radiotherapy do the remainder of the job. But first, and foremost, we must increase the weight and improve the nutritional status of the patient.

All this leads to the necessity for a new product and new protocol for a supplement feeding. A predigested protein, called EMF (Pro-Stat®), which has safety, ease of administration, efficiency, patient ease of accessibility and low cost was studied at Whitestone General Hospital in New York for 25 advanced cancer patients.

Data from Medical Nutrition Inc., Study by Dr. D. Cole, M.D. and I.S. Schwartz, R.D., Whitestone General Hospital, Whitestone, New York, Reported Nov. 1978.

(click here to Enlarge)

References

1. Terepka, A.R., Waterhouse, C.: Metabolic observations during the forced feeding of patients with cancer. Amer. J. Med. 20:225, 1956. 

2. Schwartz, G.E.,.Green, H.L., Bendon, M.L., Graham,-W.P., Blakemore, W.S.: Combined parenteral hyperalimentation and chemotherapy in the treatment of disseminated solid tumors. Amer. J. Surg. 121:169, 1971. 

3. Copeland, E.M., MadFayden, B.V., Rapp, M.A., Dudrick, S.J.: Hyperalimentation and immune competence in cancer. Surgical Forum 26:138, 1975. 

4. Hersch, E.M., Gutteman, J.V., Marligit, G.M.., McCredie, K.B., Burgess, 

5. M.A., Matthews, A., Freireich, E.J.: Serial studies of immunocompetence of patients undergoing chemotherapy for acute leukemia. J.C,;I. 54:401, 1974. 

6. Copeland, H-.M., MaeFayden, B.V., Lanzotti, V.J., Dudrick, S.J.: Intravenous hyperalimentation as.an adjunct to cancer chemotherapy. AiW. J. Surg. 129:167, 1974. 

7. Blackburn, G.L., Bist-rian, B.R.: Protein Calorie Curative Therapy in Nutritional Support of Medical Practice. H. Schneider (Edit.). Harper & Raw, 1976. 

Indications:

• Pressure Ulcers and Wound Healing

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• Hypoalbuminemia

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• Tube Feeding

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• Dialysis and Fluid Restricted

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• Bariatric Surgery

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• Cancer Cachexia

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• Nutritionally at Risk

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• Policy & Procedure

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