Home Parenteral Nutrition for Malnourished Unresectable Stage IV Gastric Cancer (NCT03121807) | Clinical Trial Compass
CompletedNot Applicable
Home Parenteral Nutrition for Malnourished Unresectable Stage IV Gastric Cancer
Taiwan25 participantsStarted 2014-09-01
Plain-language 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.
Who can participate
Age range20 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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:
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Overall survival
Timeframe: three to six months
Trial details
NCT IDNCT03121807
SponsorKaohsiung Medical University Chung-Ho Memorial Hospital