Home Parenteral Nutrition for Malnourished Unresectable Stage IV Gastric Cancer

Metastatic Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03121807
• Other study ID #: KMUHIRB-20130271
• Status: Completed
• Phase: N/A
• Start date: September 1, 2014
• Est. completion date: June 1, 2019

Study information

• Verified date: June 2019
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Malnutrition
• Metastatic Gastric Cancer
• Stomach Neoplasms

Intervention

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:
• Oxaliplatin

• 5Fluorouracil

• Leucovorin

Locations

Country	Name	City	State
Taiwan	Chung-Ho Memorial Hospital, Kaohsiung Medical University:	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Time from treatment to death of patients	three to six months
Secondary	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
Secondary	Quality of life before and after treatment	Quality of life is assessed with EORTC QLQ-C30 (version 3) questionnaire.	three to six months
Secondary	body weight in kilograms	body weight in kilograms	three to six months
Secondary	body mass index (BMI) in kg/m^2	body mass index (BMI) in kg/m^2	three to six months
Secondary	serum sugar in mg/dL	serum sugar in mg/dL	three to six months
Secondary	serum albumin in g/dL	serum albumin in g/dL	three to six months
Secondary	serum prealbumin in mg/dL	serum prealbumin in mg/dL	three to six months
Secondary	serum total protein in g/dL	serum total protein in g/dL	three to six months
Secondary	serum transferrin saturation in %	serum transferrin saturation in %	three to six months
Secondary	serum total cholesterol (TC) in mg/mL	serum total cholesterol (TC) in mg/mL	three to six months
Secondary	serum low-density lipoprotein cholesterol (LDL-C) in mg/mL	serum low-density lipoprotein cholesterol (LDL-C) in mg/mL	three to six months
Secondary	serum high-density lipoprotein cholesterol (HDL-C) in mg/mL	serum high-density lipoprotein cholesterol (HDL-C) in mg/mL	three to six months
Secondary	serum triglyceride (TG) in mg/dL	serum triglyceride (TG) in mg/dL	three to six months
Secondary	nitrogen balance in grams	nitrogen balance in grams	three to six months
Secondary	Performance status	Performance status is documented by Eastern Cooperative Oncology Group (ECOG) scale.	three to six months
Secondary	Interleukin 6 (IL-6) in pg/mL	Interleukin 6 (IL-6) in pg/mL	three to six months
Secondary	Interleukin 10 (IL-10) in pg/mL	Interleukin 10 (IL-10) in pg/mL	three to six months
Secondary	tumor necrosis factor-a (TNF-a) in pg/mL	tumor necrosis factor-a (TNF-a) in pg/mL	three to six months
Secondary	C-reactive protein (CRP) in mg/dL	C-reactive protein (CRP) in mg/dL	three to six months
Secondary	procalcitonin (PCT) in ng/mL	procalcitonin (PCT) in ng/mL	three to six months
Secondary	blood Na in mEq/L	blood Na in mEq/L	three to six months
Secondary	blood K in mEq/L	blood K in mEq/L	three to six months
Secondary	blood Ca in mg/dL	blood Ca in mg/dL	three to six months
Secondary	blood Cl in mEq/L	blood Cl in mEq/L	three to six months
Secondary	blood P in mg/dL	blood P in mg/dL	three to six months
Secondary	blood aspartate aminotransferase (AST) in U/L	blood aspartate aminotransferase (AST) in U/L	three to six months
Secondary	blood alanine aminotransferase (ALT) in U/L	blood alanine aminotransferase (ALT) in U/L	three to six months
Secondary	blood gamma-glutamyl transpeptidase (?GT) in U/L	blood gamma-glutamyl transpeptidase (?GT) in U/L	three to six months
Secondary	blood direct bilirubin in mg/dL	blood direct bilirubin in mg/dL	three to six months
Secondary	blood albumin in g/dL	blood albumin in g/dL	three to six months
Secondary	international normalized ratio (INR)	international normalized ratio (INR)	three to six months
Secondary	partial thromboplastin time (PTT) in seconds	partial thromboplastin time (PTT) in seconds	three to six months
Secondary	leukocyte-count in cells/µL	leukocyte-count in cells/µL	three to six months
Secondary	platelet-count in cells/µL	platelet-count in cells/µL	three to six months
Secondary	erythrocyte-count in cells/µL	erythrocyte-count in cells/µL	three to six months
Secondary	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
Secondary	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