Home Parenteral Nutrition for Malnourished Unresectable Stage IV Gastric Cancer

Not Applicable

Completed

• Conditions: Metastatic Gastric Cancer
• Interventions: Other: Oliclinomel N4 Per bag 1.5 L; Drug: Oxaliplatin; Drug: 5Fluorouracil; Drug: Leucovorin

• Registration Number: NCT03121807
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary

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.

Detailed 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

.

Study Timeline

• Study Start: 2014-09-01
• Study First Submitted: 2017-01-04
• Study First Submitted QC: 2017-04-17
• Study First Posted: 2017-04-20
• Primary Completion: 2019-04-01
• Status Verified: 2019-06
• Study Completion: 2019-06-01
• Last Update Submitted: 2019-06-19
• Last Update Posted: 2019-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Home parenteral nutrition	Oliclinomel N4 Per bag 1.5 L	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.
Home parenteral nutrition	5Fluorouracil	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.
Home parenteral nutrition	Oxaliplatin	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.
Home parenteral nutrition	Leucovorin	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.

Primary Outcome Measures

Name	Time	Method
Overall survival	three to six months	Time from treatment to death of patients

Secondary Outcome Measures

Name	Time	Method
serum total cholesterol (TC) in mg/mL	three to six months	serum total cholesterol (TC) in mg/mL
Side effects of salvage chemotherapy	three to six months	Side effects of salvage chemotherapy are coded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v4.03
Quality of life before and after treatment	three to six months	Quality of life is assessed with EORTC QLQ-C30 (version 3) questionnaire.
body weight in kilograms	three to six months	body weight in kilograms
body mass index (BMI) in kg/m^2	three to six months	body mass index (BMI) in kg/m\^2
serum sugar in mg/dL	three to six months	serum sugar in mg/dL
serum albumin in g/dL	three to six months	serum albumin in g/dL
serum prealbumin in mg/dL	three to six months	serum prealbumin in mg/dL
serum total protein in g/dL	three to six months	serum total protein in g/dL
serum transferrin saturation in %	three to six months	serum transferrin saturation in %
serum low-density lipoprotein cholesterol (LDL-C) in mg/mL	three to six months	serum low-density lipoprotein cholesterol (LDL-C) in mg/mL
serum high-density lipoprotein cholesterol (HDL-C) in mg/mL	three to six months	serum high-density lipoprotein cholesterol (HDL-C) in mg/mL
serum triglyceride (TG) in mg/dL	three to six months	serum triglyceride (TG) in mg/dL
nitrogen balance in grams	three to six months	nitrogen balance in grams
Performance status	three to six months	Performance status is documented by Eastern Cooperative Oncology Group (ECOG) scale.
Interleukin 6 (IL-6) in pg/mL	three to six months	Interleukin 6 (IL-6) in pg/mL
Interleukin 10 (IL-10) in pg/mL	three to six months	Interleukin 10 (IL-10) in pg/mL
tumor necrosis factor-α (TNF-α) in pg/mL	three to six months	tumor necrosis factor-α (TNF-α) in pg/mL
C-reactive protein (CRP) in mg/dL	three to six months	C-reactive protein (CRP) in mg/dL
procalcitonin (PCT) in ng/mL	three to six months	procalcitonin (PCT) in ng/mL
blood Na in mEq/L	three to six months	blood Na in mEq/L
blood K in mEq/L	three to six months	blood K in mEq/L
blood Ca in mg/dL	three to six months	blood Ca in mg/dL
blood Cl in mEq/L	three to six months	blood Cl in mEq/L
blood P in mg/dL	three to six months	blood P in mg/dL
blood aspartate aminotransferase (AST) in U/L	three to six months	blood aspartate aminotransferase (AST) in U/L
blood alanine aminotransferase (ALT) in U/L	three to six months	blood alanine aminotransferase (ALT) in U/L
blood gamma-glutamyl transpeptidase (γGT) in U/L	three to six months	blood gamma-glutamyl transpeptidase (γGT) in U/L
blood direct bilirubin in mg/dL	three to six months	blood direct bilirubin in mg/dL
blood albumin in g/dL	three to six months	blood albumin in g/dL
international normalized ratio (INR)	three to six months	international normalized ratio (INR)
platelet-count in cells/μL	three to six months	platelet-count in cells/μL
erythrocyte-count in cells/μL	three to six months	erythrocyte-count in cells/μL
Complications of HPN	three to six months	Complications of HPN include adverse events (AEs) and severe adverse events (SAEs). AEs and SAEs are coded using the MedDRA system (version 18.0, http://www.meddra.org) and summarized descriptively by system organ class.
partial thromboplastin time (PTT) in seconds	three to six months	partial thromboplastin time (PTT) in seconds
leukocyte-count in cells/μL	three to six months	leukocyte-count in cells/μL
Cycles of salvage chemotherapy completed	three to six months	How many cycles of salvage chemotherapy for unresectable metastatic or recurrent gastric cancer is completed after intervention of HPN

Trial Locations

Locations (1)

Chung-Ho Memorial Hospital, Kaohsiung Medical University: 🇨🇳 Kaohsiung, Taiwan