Home Parenteral Nutrition for Malnourished Unresectable Stage IV Gastric Cancer

A Pilot Study of Home Parenteral Nutrition for Malnourished Patients With Unresectable Stage IV Gastric Receiving Salvage Chemotherapy

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Gastric Cancer
• Intervention / Treatment: Drug: Oxaliplatin; Drug: Leucovorin; Other: Oliclinomel N4 Per bag 1.5 L; Drug: 5Fluorouracil

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 807
    • Chung-Ho Memorial Hospital, Kaohsiung Medical University:

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Home parenteral nutrition; 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.

Drug: Oxaliplatin; Other Names: Eloxatin; Drug: Leucovorin; Other Names: folinic acid; Other: 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.; Drug: 5Fluorouracil; Other Names: 5Fu

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Time from treatment to death of patients	three to six months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Investigators: Study Chair: Jaw-Yuan Jaw-Yuan, PhD, Kaohsiung Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: January 4, 2017
• First Submitted That Met QC Criteria: April 17, 2017
• First Posted (Actual): April 20, 2017

Study Record Updates

• Last Update Posted (Actual): June 21, 2019
• Last Update Submitted That Met QC Criteria: June 19, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: home parenteral nutrition
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Protective Agents; Micronutrients; Vitamins; Antidotes; Vitamin B Complex; Fluorouracil; Oxaliplatin; Leucovorin
• Other Study ID Numbers: KMUHIRB-20130271

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No