Home Parenteral Nutrition in Cancer Patients

February 20, 2014 updated by: Southwestern Regional Medical Center

An Evaluation of Quality of Life Outcomes in Cancer Patients Receiving Home Parenteral

This study is being done to examine the effect of Parenteral (intravenous) nutrition support in the home setting on quality of life in cancer patients. In addition, this study is being done to examine the effect of home parenteral nutrition on the use of pain and anti-nausea medication.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective descriptive non-randomized clinical study to examine quality of life outcomes and use of pain and anti-emetic therapy for patients receiving HPN support. The EORTC QLQ-C30 will be used to evaluate quality of life. All subjects will be monitored monthly throughout the course of treatment for a minimum of 3 months and a maximum of 1 year.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74133
        • Cancer Treatment Centers of America at Southwestern Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient who are candidates for HPN will be identified by the Nutrition and Metabolic Support Team. Patients will be appropriate for HPN as indicated by a safe home environment, readiness for discharge, and reimbursement for the therapy at home. Candidates for HPN include: Patients will a nonfunctioning gastrointestinal tract. Patients that are moderately or severely malnourished (SGA B or C) with aniticipated deterioration in nutritional status due to aggressive treatment. Patients who have failured enteral feedings for nutrition support. Patients with life expectancy of greater than 3 months.

Description

Inclusion Criteria:

  • Patients with a cancer diagnosis who have been receiving parenteral nutrition in the hospital or have started on HPN while at Cancer Treatment Centers of America and meet the criteria for home parenteral nutrition.
  • Patient expected to have a life expectancy of greater than 90 days post discharge.

Exclusion Criteria:

  • Patients less than 18 years of age
  • HPN patients who do not receive nutrition assessment and follow-up by the Coram Healthcare nutrition support team
  • Refuse to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Home Parenteral Nutrition
Patients receiving home parenteral nutrition
Dietary supplement: Home Parenteral Nutrition
Cancer Patients who are discharged on HPN will be monitored for quality of life, nutrition status, pain and nausea medication usage
Other Names:
  • Intravenous nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: Monthly for a minimum of 3 months to a maximum of 12 months
To examine the effect of parenteral nutrition support in the home care setting on quality of life as measured by the EORTC QLQ-C30
Monthly for a minimum of 3 months to a maximum of 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain and nausea medication usage
Time Frame: Monthly for a minumum of 3 months to a maximum of 12 months
To examine the effect of home parenteral nutrition on the use of pain medication and anti-emetic therapy administered intravenously, subcutaneously, or orally.
Monthly for a minumum of 3 months to a maximum of 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwestern Regional Medical Center

Investigators

  • Principal Investigator: Ross Taylor, MD, Cancer Treatment Centers of America at Southwestern Regional Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

June 24, 2010

First Submitted That Met QC Criteria

June 28, 2010

First Posted (Estimate)

June 29, 2010

Study Record Updates

Last Update Posted (Estimate)

February 21, 2014

Last Update Submitted That Met QC Criteria

February 20, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SRMC 10-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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