Title of Invention	"A METHOD FOR PROVIDING LONG TERM NUTRITION
Abstract	Pursuant to the present invention, methods and compositions are provided for providing long-term tube-fed nutrition. More specifically, pursuant to the present invention, methods and compositions are provided for providing long-term tube-fed nutrition to cancer patients.

Full Text

"LONG TERM FEED - CANCER PATIENT" BACKGROUND [0001] The present application relates to nutntion More specifically, the present invention relates to clinical nutntion [0002] Due to a vanety of diseases, insults, and complications, patients may not be able to obtain the necessary nutntion by ingesting food through the mouth, e g, eating food Therefore, it has been known to provide clinical nutntion either enterally or parenterally A vanety of different formulations have been developed to provide such clinical nutntion [0003] Even with respect to typical enteral nutntional products, these products are designed for short-term use, typically 10 to 24 days In this regard, the products usually provide the essential nutntional components to provide necessary nutntion to patients having acute pathologies dunng their hospital stays Although these products are suitable for such short term use, they have not necessanly been designed for long-term feeding of patients With advances in medicine resulting in increased life expectancy and better disease treatments, a number of individuals could benefit from products designed to provide long-term enteral nutntion SUMMARY [0004] Pursuant to the present invention, methods and compositions are provided for supplying long-term tube-fed nutntion More specifically, pursuant to the present invention, methods and compositions are provided for providing long-term tube-fed nutntion to cancer patients [0005] To this end, in an embodiment, a method for providing long term nutntion to a cancer patient compnses the steps of administering at least once a day long term through a tube to a cancer patient a nutntional product compnsing a source of protein which provides 14 to 25% by calonc content of the product wherein the protein source compnses at least 50% by calonc content whey, at least 0 5% by calonc content glutamine, at least 0 8% by calonc content leucine, a source of carbohydrates compnses 25 to 40% by calonc content of the product [0006] In an embodiment, glutamme compnses 0 5 to 10 0% by calonc content of the product The glutamme or a part of it can be packaged in a separate container from remaining components of the product The glutamine can be free as an amino acid or provided as a glutamine-nch compound such as a dipeptide The glutamme can compnse alanyl-glutamine [0007] Pursuant to the method the protein source can be intact or partially hydrolyzed protein The protein source can be 100% whey protein [0008] The lipid source can provide 30 to 35% by calonc content of the product The energy density of the product is between 1 0 to 2 0 kcal Additionally, the product can compnse a source of fiber [0009] In an embodiment, 1 5 to 3 5% by calonc content of the product is provided by leucine [0010] In an embodiment of the method, the product compnses sufficient vitamins and minerals to meet at least one government regulation selected from the group consisting of U S RDA, French RDA, and German RDA [0011] Pursuant to an embodiment of the method, the patient receives a second different tube-fed nutritional product once normo-metabohc status has been regained In another embodiment, the patient receives the second different tube-fed product before cancer is diagnosed [0012] In another embodiment of the present invention, a method of providing long term tube-fed nutntion to a cancer patient is provided compnsing the steps of administering through a tube to a cancer patient dunng an inflammatory phase and a weight gain phase a first composition compnsing a source of protein which provides 14 to 25% by calonc content of the product wherein the protem source compnses at least 50% by calonc content whey, at least 0 5% by calonc content glutamme, at least 0 8% by calonc content leucine, a source of carbohydrates that compnses 20 to 55% by calonc content of the product, and a source of lipids that compnses 25 to 40% by calonc content of the product, and administenng through a tube to a cancer patient during a normo-metabohc phase a second long-term nutritional composition that has a different composition than the first composition [0013] In an embodiment of the method, the second long-term tube-fed nutrition composition comprises per 100 kcal of product a source of protein, a source of carbohydrates, a source of lipids, sodium 100 to 200 mg, potassium 25 to 250 mg, calcium above 50 mg, phosphorus less than 150 mg, magnesium at least 15 mg, chloride at least 100 mg, iron 0 4 to 1 5 mg, zmc 0 4 to 2 0 mg, copper 0 08 to 0 4 mg, fluoride 0 to 0 15 mg, chromium 2 0 to 10 0 micrograms, molybdenum 2 0 to 14 0 micrograms, selemum 3 0 to 9 0 micrograms, manganese 0 1 to 0 4 mg, iodine 7 0 to 15 0 micrograms, Vit A 100 to 500 IU, Vit D 0 5 to 2 5 micrograms, Vit E 1 5 to 4 0 mg, Vit K greater than 4 0 micrograms, Vit C greater than 4 0 mg, Vit Bl greater than 0 06 mg, Vit B2 greater than 0 07 mg, Vit B3 0 7 to 3 5 mg, Vit B5 0 2 to 2 0 mg, Vit B6 0 1 to 0 7 mg, Vit B8 at least 1 0 micrograms, Vit B9 at least 12 0 micrograms, and Vit B12 0 1 to 1 0 micrograms [0014] In an embodiment of the method, the glutamine comprises 0 5 to 10 0% by calonc content of the product The glutamine or part of it can be packaged in a separate container from remaimng components of the product [0015] In yet a further embodiment of the present invention, a method of treating a cancer patient is provided comprising the steps of admiinstenng at least once a day long term a first nutritional composition comprising a source of protein which provides 14 to 25% by calonc content of the product wherein the protein source comprises at least 50% by calonc content whey, a source of carbohydrates that comprises 20 to 55% by calonc content of the product, and a source of lipids that comprises 25 to 40% by calonc content of the product, and pnor to a cancer treatment selected from the group consisting of chemotherapy and radiation therapy administenng along with the first nutritional composition glutamme at a level of at least 0 5% of the total calonc intake [0016] In an embodiment, the method can include the step of admimstenng to the patient after the treatment the first nutntion composition without co-administration of glutamine [0017] Still further, in an embodiment of the present invention, a composition for providing long term nutntion through a tube to a cancer patient is provided comprising a source of protein which provides 14 to 25% by calonc content of the product wherein the protein source comprises at least 50% by calonc content whey, at least 0 5% by calonc content glutamine, at least 0 8% by calonc content leucine, a source of carbohydrates that comprises 20 to 55% by calonc content of the product, and a source of lipids that comprises 25 to 40% by calonc content of the product [0018] An advantage of the present invention is to provide improved enteral nutntion products [0019] Another advantage of the present invention is to provide improved methods of providing enteral nutntion [0020] Furthermore, an advantage of the present invention is to provide enteral nutntion compositions for providing long-term tube-fed nutntion to a cancer patient [0021] Moreover, an advantage of the present invention is to provide methods of providing long-term tube-fed enteral nutntion to cancer patients [0022] Additional features and advantages are descnbed herein, and will be apparent from, the following Detailed Descnption DETAILED DESCRIPTION [0023] The present invention relates to clinical nutntion More specifically, the present invention relates to providing long-term tube-fed nutntion to patients As used herein, the term "long-term" means greater than one month (30 days) As used herein, the term "tube-fed" means to provide a product to a patient through a feed tube that is received within a portion of the digestive tract of a patient, for example, a nasogastnc feed tube or a percutaneous endoscopic gastrostomy tube Applicants are filing herewith a patent application entitled "METHODS OF PROVIDING LONG-TERM NUTRITION," the disclosure of which is incorporated herem by reference [0024] The long-term tube-fed nutntion products are preferably designed for cancer patients As used herein, "cancer patient" refers to a patient who cannot receive nutntion through a normal diet or is malnounshed and who is suffenng from an active cancer, I e, is not normo-metabohc The active cancer may be a cancer of the neck, head, or digestive tract, or it may be a recurrence of cancer in a patient who has previously suffered and been treated for a cancer of the head, neck or digestive tract which has left him or her unable to eat a normal diet As used herem, the term "normal diet" means to receive at least substantially all nutntion by eating, l e , using one's mouth, without the use of any feed tube or parenteral feed [0025] The present invention provides a nutritional formulation that, in part, will benefit patients long term as they suffer from cancer and especially during their cancer treatment, e g, chemotherapy or radiation therapy The formulation provides benefits also during the inflammatory and/or hypercatabohc episodes as compared to standard enteral nutrition products As used herein, the term "standard enteral nutrition product" refers to products that are not specifically advertised or promoted for long-term use A variety of such products are available, for example, from Nestle, Abbott, Novartis, Numico, and Fresenius Therefore, the product, in part, is hyperprotinic and hypercalonc [0026] In part, the formulation is enriched in, preferably, w3 polyunsaturated fatty acids (EPA and DHA) These fatty acids provide good anti-inflammatory characteristics, especially for patients suffering from tumors Preferably, the protein source comes from whey, specifically proteins rich in cysteme having antioxidant properties and therefore being anti-inflammatory In part, the anti-oxidant properties are provided by the glutathione synthesis which requires cysteine and glutamme as precursors [0027] The formula is designed to be utilized, at least at times, with added glutamine Glutamme can be part of the formulation or it can be provided as a separate component In this regard, the glutamine can be provided as a module The module can contain a powder or liquid form of glutamine With respect to the glutamine and other modules, reference is made to co-pendmg U S Patent Application entitled "NUTRITIONAL MODULES," filed on October 7, 2002, the disclosure of which is incorporated herein by reference By way of example, a 30g module of glutamine can be used with the 1500 ml of formula [0028] Pursuant to an embodiment of the method of the present invention, added glutamine is administered to the patient before the start of a cycle of chemo- or radio- therapy treatment, for example, a week before, and administered throughout the cycle and for a period thereafter, for example, two weeks after treatment has stopped During the administration of the glutamme, the formulation will also be administered either with the glutamme or separate therefrom In an embodiment, once acute inflammation as evidenced, for example, by mucositis has subsided, the glutamine administration can stop The module presentation of glutamine may conveniently be used to complement the formulation dunng cycles of treatment either in hospital or in a non-hospital setting, for example, home healthcare, and nursing home [0029] In addition, L-leucine is added to the formula in an amount so as to contribute from 0 8 to 5% of the energy content of the formula L-leucme is a powerful stimulator of synthesis of protein in muscles in synthesis [0030] Pursuant to an embodiment of the present invention, prior to the diagnosis of a tumour requiring treatment, if the patient requires enteral nutrition, specifically long-term enteral nutrition, preferably a maintenance formulation is utilized as described in U S Patent Application entitled "LONG-TERM ENTERAL NUTRITION - MAINTENANCE," that is being filed herewith, the disclosure of which is incorporated herein by reference Likewise, feeding with the maintenance formulation may be resumed once the cancer is in remission and the patient has achieved a normo-metabolic status [0031] Accordingly, the present invention provides long-term enteral nutrition for cancer patients that includes providing two distinct formulations, one directed to cancer patients with a tumor requiring treatment and a second for maintenance of patients once normo-metabohc status has been re-established As used herein, "maintenance patient" refers to an adult patient under the age of sixty-five who cannot receive nutrition through a normal diet but who is normo-metabohc (l e not suffering from a metabolic disorder) For the sake of clarity, Applicants note that this application discloses the cancer patient formulation except in Examples 3 and 4, as well as certain claims, wherein the maintenance patient formulation is set forth [0032] In an embodiment, the formulation of the present invention can be used to reduce the side effects of cancer and its treatment Such side effects include cachexia due to the cancer and mucositis which may be apparent dunng treatments such as chemotherapy and radiation therapy [0033] In an embodiment, the composition includes the following features a source of protein providing 14 to 25 percent of the total energy of the product, preferably 14 to 25 percent can be intact or partially hydrolysed protein of which at least 50 percent is whey In an embodiment, the protein is 100 percent whey and the protein source, including added amino acids, provides 15 to 30 percent of the total energy of the product, preferably 20 to 27% In a preferred embodiment, 3 to 7 percent of the energy is provided by glutamine and 1 5 to 3 5 percent of the energy is provided by leucine By providing 100 percent whey protein an easily absorbed and relatively high cysteine content is provided By supplementing this content with leucine, one can address the increased requirements for same in this population group [0034] A source of carbohydrates is preferably provided comprising 20 to 55 percent of the total energy of the product Any carbohydrate or mixture of carbohydrates can be used Examples include starch, maltodextnns, sucrose, and mixtures thereof In an embodiment, 100 percent maltodextnn is used [0035] In addition, the source of lipids provides 25 to 40 percent of the total energy of the product Preferably, 1 0 to 7 percent by weight of the source of lipids is eicosapentaenoic acid By providing EPA, a suitable n6 n3 ratio can be provided smce these patients are suffering from inflammation and oxidative stress Any suitable mixture of dietary lipids can be used These include saturated fatty acids (SFA), monounsaturated fatty acids (MUFA), polyunsaturated fatty acids (PUFA), and medium-chain triglycerides (MCT) Preferably, the lipid source provides 30 to 35 percent of the total caloric content of the product It should be noted that, preferably, the energy density of the composition is 1 0 to 2 0 kcal/ml [0036] The present invention provides methods as well as products that are optimized and/or improved for long-term use In an embodiment, these products are provided to the patient outside of a hospital setting For example, the products can be provided in a nursing home, daycare or other out-patient facilities, or even the home of the patient Preferably, the nutntion products are housed in a plastic bag A vanety of such bags are known, for example, 500 ml, 1000 ml, and 1500 ml bags are known in the art It should be noted, however, that any suitable container can be used to house the nutntion product In an embodiment, the product is designed to provide necessary nutntion at 1500 ml per day, although those skilled in the art will appreciate that vanations to this level are possible [0037] Preferably, the products include the necessary nutntional components to provide complete nutntion to the patient on a long-term basis In this regard, the products include, among other possible ingredients protein, carbohydrate, fat, vitamins, and minerals In an embodiment, the products substantially, if not completely, comply with at least certain governmental requirements As used herein, "governmental requirements" means any recommendations from any one of the following governments U S, typically the USRDA, German, typically the German RDA, and French, typically the French RDA In an embodiment, the nutrition product meets or exceeds at least one of the governmental requirements [0038] By way of example and not limitation, examples of the present invention will now be given [0039] Example Nos 1 and 2 are designed for use from diagnosis to the point where the tumor is in remission Example No. 1 (Table Removed) Example No. 2 (Table Removed) [0040] Example Nos 3 and 4 below are designed to provide maintenance before diagnosis of a tumor (if needed) and after the tumor has gone into remission Example No 3 (Table Removed) Example No 4 (Table Removed) [0041] By way of example and not limitation, in an embodiment of the present invention, one of the formulas set forth in Examples 1 and 2 will be administered to the patient in the penod between diagnosis and re-establishment of normo-metabohc status This product will be administered at least once a day If desired, the glutamine can be provided as a separate module Pnor to diagnosis, if required, a patient can receive a maintenance formula set forth in Examples 3 and 4 Likewise, after the treatment is finished and the tumor is in remission the patient will receive the maintenance formula set forth in Examples 3 and 4 [0042] In another embodiment of the method, after a diagnosis of cancer, 1500 ml per day of one of the formulas of Examples 1 and 2 will be administered to a patient At least one week pnor to a cancer treatment, a glutamine module with 30 g of glutamine will also be administered to the patient along with the formula Two weeks after the completion of the treatments, the glutamine supplementation will stop and the formula administration will continue as needed [0043] It should be understood that vanous changes and modifications to the presently preferred embodiments descnbed herein will be apparent to those skilled in the art Such changes and modifications can be made without departing from the spint and scope of the present subject matter and without diminishing its intended advantages It is therefore intended that such changes and modifications be covered by the appended claims We Claims 1. A method for providing long term nutrition to a cancer patient comprising the steps of: administering at least once a day long term through a tube to a cancer patient a nutritional product comprising: a source of protein which provides 14 to 25% by caloric content of the product wherein the protein source comprises at least 50% by caloric content whey; at least 0.5% by caloric content glutamine; at least 0.8% by caloric content leucine; a source of carbohydrates that comprises 20 to 55% by caloric content of the product; and a source of lipids that comprises 25 to 40% by caloric content of the product. 2. The method of claim 1 wherein glutamine comprises 0.5 to 10.0% by caloric content of the product. 3. The method of claim 1 wherein at least a part of the glutamine is packaged in a separate container from remaining components of the product. 4. The method of claim 1 wherein the protein source is intact or partially hydrolyzed protein. 5. The method of claim 1 wherein the glutamine is bound to a protein. 6. The method of claim 1 wherein the glutamine is free as an amino acid. 7. The method of claim 1 wherein the glutamine is a dipeptide. 8. The method of claim 1 wherein the protein source is 100% whey protein. 9. The method of claim 1 wherein 3 to 7% by caloric content of the product is provided by glutamine. 10. The method of claim 1 wherein 1.5 to 3.5% by caloric content of the product is provided by leucine. 11. The method of claim 1 wherein the lipid source provides 30 to 35% by caloric content of the product. 12. The method of claim 1 wherein the energy density of the product is between 1.0 to 2.0 kcal. 13. The method of claim 1 wherein the product comprises a source of fiber. 14. The method of claim 1 wherein the patient receives a second different tube-fed nutritional product after normo-metabolic status has been re-established. 15. The method of claim 1 wherein the glutamine comprises alanyl-glutamine. 16. A method of providing long term tube-fed nutrition to a cancer patient comprising the steps of: administering through a tube to a cancer patient with a tumour requiring treatment a first composition comprising: a source of protein which provides 14 to 25% by caloric content of the product wherein the protein source comprises at least 50% by caloric content whey, at least 0.5% by caloric content glutamine, at least 0.8% by caloric content leucine, a source of carbohydrates that comprises 20 to 55% by caloric content of the product, and a source of lipids that comprises 25 to 40% by caloric content of the product; and administering through a tube to the cancer patient after the normo-metabolic status has been re-established a second long-term nutritional composition that has a different composition than the first composition. 17. The method of claim 16 wherein the second long-term nutritional composition comprises per 100 kcal of product: a source of protein; a source of carbohydrates; a source of lipids; sodium 100 to 200 mg; potassium 25 to 250 mg; calcium above 50 mg; phosphorus less than 150 mg; magnesium at least 15 mg; chloride at least 100 mg; iron 0.4 to 1.5 mg; zinc 0.4 to 2.0 mg; copper 0.08 to 0.4 mg; fluoride 0 to 0.15 mg; chromium 2.0 to 10.0 micrograms; molybdenum 2.0 to 14.0 micrograms; selenium 3.0 to 9.0 micrograms; manganese 0.1 to 0.4 mg; iodine 7.0 to 15.0 micrograms Vit A 100 to 500IU; Vit D 0.5 to 2.5 micrograms; Vit E 1.5 to 4.0 mg; Vit K greater than 4.0 micrograms; Vit C greater than 4.0 mg; Vit Bl greater than 0.06 mg; Vit B2 greater than 0.07 mg; Vit B3 0.7 to 3.5 mg; Vit B5 0.2 to 2.0 mg; Vit B6 0.1 to0.7mg; Vit B8 at least 1.0 micrograms; Vit B9 at least 12.0 micrograms; and Vit B12 0.1 to 1.0 micrograms. 18. The method of claim 16 wherein glutamine comprises 0.5 to 10.0% by caloric content of the product. 19. The method of claim 16 wherein glutamine is packaged in a separate container from remaining components of the product. 20. The method of claim 16 wherein the protein source is intact or partially hydrolyzed protein. 21. The method of claim 16 wherein the protein source is 100% whey protein. 22. The method of claim 16 wherein 3 to 7% by caloric content of the product is provided by glutamine. 23. The method of claim 16 wherein 1.5 to 3.5% by caloric content of the product is provided by leucine. 24. The method of claim 16 wherein the energy density of the product is between 1.0 to 2.0 kcal. 25. The method of claim 16 comprising a source of fiber. 26. A method of providing long-term nutrition through a tube to a cancer patient comprising the steps of: administering at least once a day long term of the diagnosis a nutritional composition comprising a source of protein which provides 14 to 25% by caloric content of the product wherein the protein source comprises at least 50% by caloric content whey; a source of carbohydrates that comprises 20 to 55% by caloric content of the product; and a source of lipids that comprises 25 to 40% by caloric content of the product; and administering, at least one week prior to a cancer treatment, glutamine with the nutritional composition. 27. The method of claim 26 including the step of administering to the patient the glutamine as a separate module. 28. A composition for providing long term nutrition through a tube to a cancer patient comprising: a source of protein which provides 14 to 25% by caloric content of the product wherein the protein source comprises at least 50% by caloric content whey; at least 0.5% by caloric content glutamine; at least 0.8% by caloric content leucine; a source of carbohydrates that comprises 20 to 55% by caloric content of the product; and a source of lipids that comprises 25 to 40% by caloric content of the product. 29. The composition of claim 28 wherein glutamine comprises 0.5 to 10.0% by caloric content of the product. 30. The composition of claim 28 wherein glutamine is packaged in a separate container from remaining components of the product. 31. The composition of claim 28 wherein 14 to 25% by caloric content of the protein source is intact or partially hydrolyzed protein. 32. The composition of claim 28 wherein the protein source is 100% whey protein. 33. The composition of claim 28 wherein 3 to 7% by caloric content of the product is provided by glutamine. 34. The composition of claim 28 wherein 1.5 to 3.5% by caloric content of the product is provided by leucine. 35. The composition of claim 28 wherein the lipid source provides 30 to 35% by caloric content of the product. 36. The composition of claim 28 wherein the energy density of the product is between 1.0 to 2.0 kcal. 37. The composition of claim 28 wherein the product comprises a source of fiber.

Documents:

2583-delnp-2009-abstract.pdf

2583-delnp-2009-Claims-(08-01-2014).pdf

2583-delnp-2009-Claims-(09-05-2014).pdf

2583-delnp-2009-Claims-(22-04-2014).pdf

2583-delnp-2009-claims.pdf

2583-delnp-2009-Correspondence Others-(05-09-2013).pdf

2583-delnp-2009-Correspondence Others-(08-01-2014).pdf

2583-delnp-2009-Correspondence Others-(09-05-2014).pdf

2583-delnp-2009-Correspondence Others-(16-09-2013).pdf

2583-delnp-2009-Correspondence Others-(22-04-2014).pdf

2583-delnp-2009-Correspondence Others-(24-04-2014).pdf

2583-DELNP-2009-Correspondence-Others (06-10-2009).pdf

2583-DELNP-2009-Correspondence-Others-(05-02-2013).pdf

2583-delnp-2009-correspondence-others.pdf

2583-delnp-2009-description (complete).pdf

2583-delnp-2009-form-1.pdf

2583-delnp-2009-Form-18-(29-04-2009).pdf

2583-delnp-2009-Form-2-(08-01-2014).pdf

2583-delnp-2009-form-2.pdf

2583-DELNP-2009-Form-3 (06-10-2009).pdf

2583-delnp-2009-Form-3-(05-09-2013).pdf

2583-delnp-2009-Form-3-(24-04-2014).pdf

2583-delnp-2009-form-3.pdf

2583-delnp-2009-form-5.pdf

2583-delnp-2009-GPA-(08-01-2014).pdf

2583-delnp-2009-gpa.pdf

2583-delnp-2009-pct-101.pdf

2583-delnp-2009-pct-210.pdf

2583-delnp-2009-Petition-137-(05-09-2013).pdf