Home Parenteral Nutrition for Malnourished Unresectable Stage IV Gastric Cancer
Home Parenteral Nutrition for Malnourished Unresectable Stage IV Gastric Cancer
This survey is a single arm study to assess the effect of home parenteral nutrition on
 overall survival, cycles of salvage chemotherapy completed, side effects of salvage
 chemotherapy, quality of life, nutritional status, functional status, inflammatory status and
 complications of HPN in malnourished unresectable metastatic gastric cancer (mGC) patients in
 a single medical center. It is expected that about 20 subjects will be recruited during an
 estimated period of 48 months.
Objectives:

 1. Primary Objective:

 The primary end points are overall survival and cycles of salvage chemotherapy completed
 of malnourished patients in unresectable mGCs

 2. Secondary Objectives:

 Side effects of salvage chemotherapy, quality of life, nutritional status, performance
 status, inflammatory status, safety and complications of HPN. The visit time schedules are at
 the time of enrollment before HPN is delivered, and at the beginning of every cycle of
 salvage chemotherapy

 Patient Selection and Enrollment:

 Twenty patients are planed to be enrolled

 Drop out The following reasons may consider to withdrawing a patient from the study

 1. Intolerance adverse events

 2. Patient will exceed defined safety cut-off values e.g. increase of a certain amount of a
 laboratory parameter.

 3. Violation of study protocol

 4. Withdraw of informed consent.

 Study duration and dates The study of this protocol is expected to be approximately 24
 months, with a subject recruitment period of 18 months (proposed to start in Sep 2014 and end
 in Sep 2018). The duration of the study or period of recruitment may vary.

 Treatment duration HPN is administered till resolution of malnutrition or till patient dies

 .
Inclusion Criteria:

 1. Histology confirmed adenocarcinoma of stomach.

 2. Stage IV (AJCC 7.0)

 3. Malnourished patients with nutritional risk index (NRI) < 97.5. NRI= 1.59 x serum
 albumin level (g/L) + 0.417 x (current weight/usual weight) x 100

 4. Adequate organ function as defined by the following criteria:

 -  absolute neutrophil count (ANC) > or =1500 cells/mm3;

 -  platelets > or =60,000 cells/mm3

 -  hemoglobin > or =8.0 g/dL

 -  AST and ALT < or =3.0 x upper limit of normal (ULN), unless there are liver
 metastases in which case AST and ALT< or =5.0 x ULN;

 -  total bilirubin < or =2.0x ULN

 -  serum creatinine < or =2.0 x ULN or calculated creatinine clearance > or =60
 mL/min

 5. Male or female, age > or = 20 years and < 80 years.

 6. Women of childbearing potential must have a negative serum or urine pregnancy test
 within 3 days prior to treatment.

 7. Signed and dated informed consent document indicating that the patient (or legally
 acceptable representative) has been informed of all pertinent aspects of the trial
 prior to enrollment.

 Exclusion Criteria:

 1. Known allergy to components of studied parenteral nutrition.

 2. Acute shock or collapse.

 3. Known diabetic ketoacidosis 7 days prior to randomization.

 4. Unstable conditions (e.g. uncompensated diabetes mellitus, acute myocardial
 infarction, embolism, metabolic acidosis, severe sepsis and hypotonic dehydration).

 5. General contraindications to infusion therapy: acute pulmonary edema, hyperhydration,
 uncompensated cardiac insufficiency.

 6. Investigator judges as subjects to be inappropriate for the clinical study (e.g.,
 patient with severe complications)

 7. Active seizure disorder or evidence of brain metastases, spinal cord compression, or
 carcinomatous meningitis.

 8. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
 related illness.

 9. Participation in another clinical study with an investigational drug or an
 investigational medical device within 1 month prior to start of the study or during
 the study.

 10. Female patients who are pregnant or lactating, or men and women of reproductive
 potential not willing or not able to employ an effective method of birth
 control/contraception to prevent pregnancy during treatment and for 6 months after
 discontinuing study treatment. The definition of effective contraception should be in
 agreement with local regulation and based on the judgment of the principal
 investigator or a designated associate.