Clinical trial NCT03121807: Home Parenteral Nutrition for Malnourished Unresectable Stage IV Gastric Cancer
Official title: A Pilot Study of Home Parenteral Nutrition for Malnourished Patients With Unresectable Stage IV Gastric Receiving Salvage Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Gastric Cancer
Keywords: home parenteral nutrition
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2017-04-20
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival
timeFrame: three to six months
Secondary outcomes:
measure: Side effects of salvage chemotherapy
timeFrame: three to six months
measure: Quality of life before and after treatment
timeFrame: three to six months
measure: body weight in kilograms
timeFrame: three to six months
measure: body mass index (BMI) in kg/m^2
timeFrame: three to six months
measure: serum sugar in mg/dL
timeFrame: three to six months
measure: serum albumin in g/dL
timeFrame: three to six months
measure: serum prealbumin in mg/dL
timeFrame: three to six months
measure: serum total protein in g/dL
timeFrame: three to six months
measure: serum transferrin saturation in %
timeFrame: three to six months
measure: serum total cholesterol (TC) in mg/mL
timeFrame: three to six months
measure: serum low-density lipoprotein cholesterol (LDL-C) in mg/mL
timeFrame: three to six months
measure: serum high-density lipoprotein cholesterol (HDL-C) in mg/mL
timeFrame: three to six months
measure: serum triglyceride (TG) in mg/dL
timeFrame: three to six months
measure: nitrogen balance in grams
timeFrame: three to six months
measure: Performance status
timeFrame: three to six months
measure: Interleukin 6 (IL-6) in pg/mL
timeFrame: three to six months
measure: Interleukin 10 (IL-10) in pg/mL
timeFrame: three to six months
measure: tumor necrosis factor-α (TNF-α) in pg/mL
timeFrame: three to six months
measure: C-reactive protein (CRP) in mg/dL
timeFrame: three to six months
measure: procalcitonin (PCT) in ng/mL
timeFrame: three to six months
measure: blood Na in mEq/L
timeFrame: three to six months
measure: blood K in mEq/L
timeFrame: three to six months
measure: blood Ca in mg/dL
timeFrame: three to six months
measure: blood Cl in mEq/L
timeFrame: three to six months
measure: blood P in mg/dL
timeFrame: three to six months
measure: blood aspartate aminotransferase (AST) in U/L
timeFrame: three to six months
measure: blood alanine aminotransferase (ALT) in U/L
timeFrame: three to six months
measure: blood gamma-glutamyl transpeptidase (γGT) in U/L
timeFrame: three to six months
measure: blood direct bilirubin in mg/dL
timeFrame: three to six months
measure: blood albumin in g/dL
timeFrame: three to six months
measure: international normalized ratio (INR)
timeFrame: three to six months
measure: partial thromboplastin time (PTT) in seconds
timeFrame: three to six months
measure: leukocyte-count in cells/μL
timeFrame: three to six months
measure: platelet-count in cells/μL
timeFrame: three to six months
measure: erythrocyte-count in cells/μL
timeFrame: three to six months
measure: Complications of HPN
timeFrame: three to six months
measure: Cycles of salvage chemotherapy completed
timeFrame: three to six months
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Chung-Ho Memorial Hospital, Kaohsiung Medical University:
Study officials:
affiliation: Kaohsiung Medical University
name: Jaw-Yuan Jaw-Yuan, PhD
role: STUDY_CHAIR
References: