Home Parenteral Nutrition for Malnourished Unresectable Stage IV Gastric Cancer

NCT03121807 | Completed

• 1 other identifier: KMUHIRB-20130271
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Gastric Cancer

Keywords

home parenteral nutrition

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Time from treatment to death of patients

  three to six months

Secondary Outcomes (37)

• Side effects of salvage chemotherapy

  three to six months

• Quality of life before and after treatment

  three to six months

• body weight in kilograms

  three to six months

• body mass index (BMI) in kg/m^2

  three to six months

• serum sugar in mg/dL

  three to six months

Study Arms (1)

Home parenteral nutrition

EXPERIMENTAL

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.

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

Interventions

Oliclinomel N4 Per bag 1.5 L OTHER

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.

Home parenteral nutrition

Oxaliplatin DRUG

Also known as: Eloxatin

Home parenteral nutrition

5Fluorouracil DRUG

Also known as: 5Fu

Home parenteral nutrition

Leucovorin DRUG

Also known as: folinic acid

Home parenteral nutrition

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histology confirmed adenocarcinoma of stomach.
• Stage IV (AJCC 7.0)
• 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
• 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
• Male or female, age \> or = 20 years and \< 80 years.
• Women of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to treatment.
• 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.

You may not qualify if:

• Known allergy to components of studied parenteral nutrition.
• Acute shock or collapse.
• Known diabetic ketoacidosis 7 days prior to randomization.
• Unstable conditions (e.g. uncompensated diabetes mellitus, acute myocardial infarction, embolism, metabolic acidosis, severe sepsis and hypotonic dehydration).
• General contraindications to infusion therapy: acute pulmonary edema, hyperhydration, uncompensated cardiac insufficiency.
• Investigator judges as subjects to be inappropriate for the clinical study (e.g., patient with severe complications)
• Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis.
• Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness.
• 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.
• 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.

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Chung-Ho Memorial Hospital, Kaohsiung Medical University:

Kaohsiung City, 807, Taiwan

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Oxaliplatin; Fluorouracil; Leucovorin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Jaw-Yuan Jaw-Yuan, PhD

  Kaohsiung Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: April 20, 2017
• Study Start: September 1, 2014
• Primary Completion: April 1, 2019
• Study Completion: June 1, 2019
• Last Updated: June 21, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)