NCT01700062

Brief Summary

aimed at investigating the efficacy, safety, and clinical outcome of Medium-Calorie or standard-calorie total parenteral nutrition (TPN) for patients with gastrointestinal cancer undergoing surgery

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2012

Completed
Last Updated

October 4, 2012

Status Verified

October 1, 2012

Enrollment Period

1.6 years

First QC Date

October 2, 2012

Last Update Submit

October 2, 2012

Conditions

Colorectal Neoplasms

Keywords

medium-caloriestandard calorieparenteral nutrition

Outcome Measures

Primary Outcomes (1)

  • biochemistry data; Various inflammation-related cytokines ;

    7 days

Secondary Outcomes (1)

  • clinical outcome(hospital stay..)

    2 months

Study Arms (2)

Medium calorie

EXPERIMENTAL
Dietary Supplement: Total Parenteral Nutrition (TPN)

standard calorie

EXPERIMENTAL
Dietary Supplement: Total Parenteral Nutrition (TPN)

Interventions

Total Parenteral Nutrition (TPN)DIETARY_SUPPLEMENT

Medium calorie ,Nonprotein calories 20 Kcal/Kg/day,Protein 1g/Kg,Fat emulsion 0.5 g/kg/day D1-D6 post OP standard calorie, Nonprotein calories 30 Kcal/Kg/day,Protein 1.5 g/Kg,Fat emulsion 50g/day D1-D6 post OP

Medium caloriestandard calorie

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients considered for major surgery for colorectal cancer Expected requirement for post operative PN or TPN of at least for 7 days Age \>18 Hemodynamically stable Written Informed Consent

You may not qualify if:

  • Hemodynamic failure of any organ Renal insufficiency Patients with severe liver dysfunction Albumin \< 3g/dL DM with poor blood sugar control

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Hospital

Kaohsiung City, Kaohsiung, 80756, Taiwan

Location

MeSH Terms

Conditions

Colorectal NeoplasmsHyperphagia

Interventions

Parenteral Nutrition, Total

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Parenteral NutritionFeeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • JF CHUANG, M.S.

    Department of pharmacy, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan

    PRINCIPAL INVESTIGATOR

  • JY WANG, M.D.

    Departments of Surgery Kaohsiung Medical University Hospital, Kaohsiung, Taiwan

    STUDY CHAIR

  • YB HUANG, Ph.D.

    Departments of Pharmacy, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of pharmacy, leader

Study Record Dates

First Submitted

October 2, 2012

First Posted

October 4, 2012

Study Start

April 1, 2007

Primary Completion

November 1, 2008

Study Completion

December 1, 2008

Last Updated

October 4, 2012

Record last verified: 2012-10

Locations

TW(1)