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Metastatic Gastric CancerNCT03121807

Home Parenteral Nutrition for Malnourished Unresectable Stage IV Gastric Cancer

A study testing Oliclinomel N4 Per bag 1.5 L, Oxaliplatin and 5Fluorouracil in people with Metastatic Gastric Cancer, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Metastatic Gastric Cancer
What is being tested?
Oliclinomel N4 Per bag 1.5 L, Oxaliplatin and 5Fluorouracil
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteTaiwan
Study dates
1 Sep 2014to 1 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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)
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  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Chung-Ho Memorial Hospital, Kaohsiung Medical University:

    Kaohsiung City, 807

Other trials in Taiwan

About this study

Official title: 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.

Read the 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

.

Being tested
Oliclinomel N4 Per bag 1.5 L, Oxaliplatin, 5Fluorouracil, Leucovorin
Keywords
home parenteral nutrition
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oliclinomel N4 Per bag 1.5 LOther

    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.

  • OxaliplatinDrug

    Also called Eloxatin

  • 5FluorouracilDrug

    Also called 5Fu

  • LeucovorinDrug

    Also called folinic acid

Study groups in NCT03121807
Study groupRoleWhat they receive
Home parenteral nutritionExperimentalHome 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.
Receives: Other: Oliclinomel N4 Per bag 1.5 L; Drug: Oxaliplatin; Drug: 5Fluorouracil; Drug: Leucovorin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Time from treatment to death of patients

    Measured: three to six months

Secondary outcomes (37)

  1. 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

    Measured: three to six months

  2. Quality of life before and after treatment

    Quality of life is assessed with EORTC QLQ-C30 (version 3) questionnaire.

    Measured: three to six months

  3. body weight in kilograms

    body weight in kilograms

    Measured: three to six months

  4. body mass index (BMI) in kg/m^2

    body mass index (BMI) in kg/m^2

    Measured: three to six months

  5. serum sugar in mg/dL

    serum sugar in mg/dL

    Measured: three to six months

  6. serum albumin in g/dL

    serum albumin in g/dL

    Measured: three to six months

  7. serum prealbumin in mg/dL

    serum prealbumin in mg/dL

    Measured: three to six months

  8. serum total protein in g/dL

    serum total protein in g/dL

    Measured: three to six months

  9. serum transferrin saturation in %

    serum transferrin saturation in %

    Measured: three to six months

  10. serum total cholesterol (TC) in mg/mL

    serum total cholesterol (TC) in mg/mL

    Measured: three to six months

  11. serum low-density lipoprotein cholesterol (LDL-C) in mg/mL

    serum low-density lipoprotein cholesterol (LDL-C) in mg/mL

    Measured: three to six months

  12. serum high-density lipoprotein cholesterol (HDL-C) in mg/mL

    serum high-density lipoprotein cholesterol (HDL-C) in mg/mL

    Measured: three to six months

  13. serum triglyceride (TG) in mg/dL

    serum triglyceride (TG) in mg/dL

    Measured: three to six months

  14. nitrogen balance in grams

    nitrogen balance in grams

    Measured: three to six months

  15. Performance status

    Performance status is documented by Eastern Cooperative Oncology Group (ECOG) scale.

    Measured: three to six months

  16. Interleukin 6 (IL-6) in pg/mL

    Interleukin 6 (IL-6) in pg/mL

    Measured: three to six months

  17. Interleukin 10 (IL-10) in pg/mL

    Interleukin 10 (IL-10) in pg/mL

    Measured: three to six months

  18. tumor necrosis factor-α (TNF-α) in pg/mL

    tumor necrosis factor-α (TNF-α) in pg/mL

    Measured: three to six months

  19. C-reactive protein (CRP) in mg/dL

    C-reactive protein (CRP) in mg/dL

    Measured: three to six months

  20. procalcitonin (PCT) in ng/mL

    procalcitonin (PCT) in ng/mL

    Measured: three to six months

  21. blood Na in mEq/L

    blood Na in mEq/L

    Measured: three to six months

  22. blood K in mEq/L

    blood K in mEq/L

    Measured: three to six months

  23. blood Ca in mg/dL

    blood Ca in mg/dL

    Measured: three to six months

  24. blood Cl in mEq/L

    blood Cl in mEq/L

    Measured: three to six months

  25. blood P in mg/dL

    blood P in mg/dL

    Measured: three to six months

  26. blood aspartate aminotransferase (AST) in U/L

    blood aspartate aminotransferase (AST) in U/L

    Measured: three to six months

  27. blood alanine aminotransferase (ALT) in U/L

    blood alanine aminotransferase (ALT) in U/L

    Measured: three to six months

  28. blood gamma-glutamyl transpeptidase (γGT) in U/L

    blood gamma-glutamyl transpeptidase (γGT) in U/L

    Measured: three to six months

  29. blood direct bilirubin in mg/dL

    blood direct bilirubin in mg/dL

    Measured: three to six months

  30. blood albumin in g/dL

    blood albumin in g/dL

    Measured: three to six months

  31. international normalized ratio (INR)

    international normalized ratio (INR)

    Measured: three to six months

  32. partial thromboplastin time (PTT) in seconds

    partial thromboplastin time (PTT) in seconds

    Measured: three to six months

  33. leukocyte-count in cells/μL

    leukocyte-count in cells/μL

    Measured: three to six months

  34. platelet-count in cells/μL

    platelet-count in cells/μL

    Measured: three to six months

  35. erythrocyte-count in cells/μL

    erythrocyte-count in cells/μL

    Measured: three to six months

  36. 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.

    Measured: three to six months

  37. Cycles of salvage chemotherapy completed

    How many cycles of salvage chemotherapy for unresectable metastatic or recurrent gastric cancer is completed after intervention of HPN

    Measured: three to six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2017
  2. Study start1 Sep 2014
  3. Primary completion1 Apr 2019
  4. Study completion1 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03121807
Sponsor's protocol ID
KMUHIRB-20130271
Status last verified
Jun 2019
First submitted
4 Jan 2017
Last updated
21 Jun 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Oliclinomel N4 Per bag 1.5 L, Oxaliplatin and 5Fluorouracil in people with Metastatic Gastric Cancer, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: three to six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03121807.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2019.

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