Home Parenteral Nutrition for Malnourished Unresectable Stage IV Gastric Cancer

Kaohsiung Medical University

Status: Completed

Conditions: Metastatic Gastric Cancer

Treatments: Drug: Oxaliplatin; Drug: Leucovorin; Other: Oliclinomel N4 Per bag 1.5 L; Drug: 5Fluorouracil

Study type: Interventional

Funder types: Other

Identifiers

NCT03121807

KMUHIRB-20130271

Details and patient eligibility

About

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.

Full description

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

.

Enrollment: 25 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Home parenteral nutrition

Experimental group

Description:

Home parenteral nutrition with 910 kcal/day , including 33 g amino acid/day, 120 g glucose/day, 30 g lipid/day and electrolyte, micro-element and vitamin according to the nutritional status of subjects and followed the standard procedure of the hospital (Oliclinomel N4 Per bag 1.5 L), was infused continuously daily in an infusion time ranged between 18-24 hours. Patients received 85 mg/m2 oxaliplatin and 200 mg/m2 leucovorin as a 2-h intravenous infusion on day 1, followed by 2400 mg/m2 5Fluorouracil as a 46-h continuous infusion. This regimen is repeated every 14 days as a cycle.

Treatment:

Other: Oliclinomel N4 Per bag 1.5 L

Drug: 5Fluorouracil

Drug: Leucovorin

Drug: Oxaliplatin