Home Parenteral Nutrition in Cancer Patients

Completed

• Conditions: Cancer
• Interventions: Dietary Supplement: Home Parenteral Nutrition

• Registration Number: NCT01152879
• Lead Sponsor: Southwestern Regional Medical Center

Brief Summary

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.

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 Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-06-24
• Study First Submitted QC: 2010-06-28
• Study First Posted: 2010-06-29
• Primary Completion: 2013-05
• Study Completion: 2013-06
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-20
• Last Update Posted: 2014-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Home Parenteral Nutrition	Home Parenteral Nutrition	Patients receiving home parenteral nutrition

Primary Outcome Measures

Name	Time	Method
Quality of Life	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

Secondary Outcome Measures

Name	Time	Method
Pain and nausea medication usage	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.

Trial Locations

Locations (1)

Cancer Treatment Centers of America at Southwestern Regional Medical Center; 🇺🇸 Tulsa, Oklahoma, United States