# US 2018/0021279 A1 · Treatment or prevention of surgery-induced cachexia and/or expression of myeloid-derived suppressor cells and pro-inflammatory cytokines

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- Number: US 2018/0021279 A1
- Document ID: US20180021279A1
- Status: Published application
- Kind: A1
- Application number: 15/548,186
- Filed: 2016-02-15
- Published: 2018-01-25
- Earliest claimed: 2015-02-13
- Assignees: Nestec S.A.
- Applicants: Nestec S.A.
- Inventors: Jill Hamilton-Reeves; Jeffrey M. Holzbeierlein; Thomas Yankee
- Web page: https://patentgrep.com/patent/US20180021279A1

## CPC

- A61K 31/198: Alpha-amino acids, e.g. alanine or edetic acid [EDTA] (betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00)
- A23L 33/12: Fatty acids or derivatives thereof
- A23L 33/13: Nucleic acids or derivatives thereof (A23L33/145 takes precedence)
- A23L 33/14: Yeasts or derivatives thereof
- A23L 33/155: Vitamins A or D
- A23L 33/175: Amino acids
- A23L 33/30: {Dietetic or nutritional methods, e.g. for losing weight (A23L33/10 takes precedence)}
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/0095: {Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches (A61K9/0007 takes precedence; eatable gels or foams A61K9/0056; oral mucosa adhesive forms A61K9/006)}
- A61K 31/07: Retinol compounds, e.g. vitamin A (retinoic acids A61K31/203)
- A61K 31/202: having three or more double bonds, e.g. linolenic (eicosanoids, e.g. leukotrienes A61K31/557)
- A61K 31/70: Carbohydrates; Sugars; Derivatives thereof (sorbitol A61K31/047)
- A61K 31/7088: Compounds having three or more nucleosides or nucleotides
- A61P 1/00: Drugs for disorders of the alimentary tract or the digestive system
- A61P 1/04: for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
- A61P 3/00: Drugs for disorders of the metabolism (of the blood or the extracellular fluid A61P7/00)
- A61P 3/02: Nutrients, e.g. vitamins, minerals
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 31/04: Antibacterial agents
- A61P 35/00: Antineoplastic agents
- A61P 37/02: Immunomodulators
- A61P 37/04: Immunostimulants
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A23L: FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF (preservation thereof A23B)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A23V: INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION

## Abstract

A specialized immunonutrition supplement can be administered to a surgical patient to reduce post-operative complications by restraining the expansion of myeloid-derived suppressor cells. The supplement includes one or more of L-arginine, omega-3 fatty acids, vitamin A, and dietary nucleotides, preferably all four of these compounds. The supplement is administered to the patient at least once per day for a time period extending from a pre-operative day that is three to seven days prior to a bladder surgery of the patient to a post-operative day that is three to seven days after the bladder surgery. The supplement can be administered to treat or prevent post-operative paralytic ileus in a bladder cancer patient; treat or prevent surgery-induced, inflammation-induced or cancer-induced cachexia; reduce the incidence of chronic infections resulting from expansion of myeloid-derived suppressor cells in a patient; and/or reduce mRNA expression of pro-inflammatory cytokines in a patient.

## Claims

### Claim 1

A method of treating a surgical patient to reduce post-operative complications by restraining the expansion of myeloid-derived suppressor cells, the method comprising:
administering to the surgical patient a specialized immunonutrition supplement comprising a component selected from the group consisting of L-arginine, omega-3 fatty acids, vitamin A, nucleotides, and mixtures thereof, the supplement is administered to the surgical patient at least once per day for a time period extending from a pre-operative day that is three to seven days prior to a bladder surgery of the surgical patient to a post-operative day that is three to seven days after the bladder surgery.

### Claim 2 (depends on 1)

The method of claim 1 wherein the supplement comprises L-arginine and is administered to the surgical patient in a daily dose that provides between about 5 g and about 30 g of the L-arginine per day.

### Claim 3 (depends on 1)

The method of claim 1 wherein the supplement comprises omega-3 fatty acids and is administered to the surgical patient in a daily dose that provides an amount of the omega-3 fatty acids that comprises about 0.5 g to about 10.0 g of eicosapentaenoic acid and docosahexaenoic acid in total per day.

### Claim 4 (depends on 1)

The method of claim 1 wherein the supplement comprises Vitamin A and is administered to the surgical patient in a daily dose that provides at least about 500 μg RE of the Vitamin A per day.

### Claim 5 (depends on 1)

The method of claim 1 wherein the supplement comprises nucleotides and is administered to the surgical patient in a daily dose that provides between about 0.5 and about 10.0 mg of nucleotides per day.

### Claim 6 (depends on 1)

The method of claim 1 wherein the component comprises L-arginine, omega-3 fatty acids, and nucleotides.

### Claim 7

(canceled)

### Claim 8 (depends on 1)

The method of claim 1 wherein the supplement comprises nucleotides, and at least a portion of the nucleotides are provided by polymeric yeast RNA and/or derived from yeast RNA.

### Claim 9 (depends on 1)

The method of claim 1 wherein the supplement is orally administered to the surgical patient.

### Claim 10

(canceled)

### Claim 11 (depends on 1)

The method of claim 1 wherein the supplement further comprises an additional component selected from the group consisting of a protein, a carbohydrate, a lipid, and mixtures thereof.

### Claim 12 (depends on 1)

The method of claim 1 wherein the surgical patient has bladder cancer associated with a tumor, and the bladder surgery comprises removal of all or part of the tumor.

### Claim at position 13

13-14. (canceled)

### Claim 15

A method of treating or preventing cachexia induced by at least one of surgery, cancer or infection in a patient, the method comprising administering to the patient a specialized immunonutrition supplement comprising a component selected from the group consisting of L-arginine, omega-3 fatty acids, vitamin A, nucleotides, and mixtures thereof.

### Claim 16 (depends on 15)

The method of claim 15 wherein the cachexia is induced by surgery, and the supplement is administered to the patient at least once per day for a time period extending from a pre-operative day that is three to seven days prior to the surgery of the patient to a post-operative day that is three to seven days after the surgery.

### Claim at position 16

17-19. (canceled)

### Claim 20 (depends on 15)

The method of claim 15 wherein the cachexia is induced by cancer associated with a tumor and treated by a surgery comprising removal of all or part of the tumor.

### Claim 21

(canceled)

### Claim 22 (depends on 15)

The method of claim 15 wherein the cachexia is induced by infection.

### Claim 23 (depends on 15)

The method of claim 15 wherein the supplement comprises L-arginine and is administered to the patient in a daily dose that provides between about 5 g and about 30 g of the L-arginine per day.

### Claim 24 (depends on 15)

The method of claim 15 wherein the component comprises L-arginine, omega-3 fatty acids, and nucleotides.

### Claim 25

(canceled)

### Claim 26

A method of achieving at least one result selected from the group consisting of reducing the incidence of chronic infections resulting from expansion of myeloid-derived suppressor cells in a patient, reducing mRNA expression of pro-inflammatory cytokines in a patient, treating or preventing post-operative paralytic ileus in a bladder cancer patient, the method comprising:
administering to the patient a specialized immunonutrition supplement comprising a component selected from the group consisting of L-arginine, omega-3 fatty acids, vitamin A, nucleotides, and mixtures thereof.

### Claim 27 (depends on 26)

The method of claim 26 wherein the patient has or is at risk of a Staphylococcus aureus infection.

### Claim 28 (depends on 26)

The method of claim 26 wherein the patient has a tumor, and the supplement is administered to the patient at least once per day for a time period extending from a pre-operative day that is three to seven days prior to removal of all or part of the tumor to a post-operative day that is three to seven days after the removal.

### Claim 29

(canceled)

### Claim 30 (depends on 26)

The method of claim 26 wherein the supplement comprises L-arginine and is administered to the patient in a daily dose that provides between about 5 g and about 30 g of the L-arginine per day.

### Claim 31 (depends on 26)

The method of claim 26 wherein the component comprises L-arginine, omega-3 fatty acids, and nucleotides.

### Claim at position 29

32-33. (canceled)

### Claim 34 (depends on 26)

The method of claim 26 wherein the patient has or is at risk of systemic inflammatory response syndrome.

### Claim at position 31

35-41. (canceled)

### Claim 42 (depends on 26)

The method of claim 26 wherein the surgery comprises radical cystoprostatectomy with urinary diversion.

### Claim at position 33

43-48. (canceled)