CancerNCT01152879
Home Parenteral Nutrition in Cancer Patients
An observational study of Cancer, run by Southwestern Regional Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Home Parenteral Nutrition
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Jun 2013
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Treatment Centers of America at Southwestern Regional Medical Center
Tulsa, Oklahoma, 74133
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Home Parenteral Nutrition
- Keywords
- Parenteral Nutrition, Quality of Life
- Medical subject headings
- Neoplasms, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Parenteral NutritionDietary supplement
Also called Intravenous nutrition
Cancer Patients who are discharged on HPN will be monitored for quality of life, nutrition status, pain and nausea medication usage
| Study group | Role | What they receive |
|---|---|---|
| Home Parenteral Nutrition | Patients receiving home parenteral nutrition Receives: Dietary Supplement: Home Parenteral Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
To examine the effect of parenteral nutrition support in the home care setting on quality of life as measured by the EORTC QLQ-C30
Measured: Monthly for a minimum of 3 months to a maximum of 12 months
Secondary outcomes (1)
Pain and nausea medication usage
To examine the effect of home parenteral nutrition on the use of pain medication and anti-emetic therapy administered intravenously, subcutaneously, or orally.
Measured: Monthly for a minumum of 3 months to a maximum of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southwestern Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ross Taylor, MD, Principal investigator, Cancer Treatment Centers of America at Southwestern Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152879
- Sponsor's protocol ID
- SRMC 10-03
- Status last verified
- Feb 2014
- First submitted
- 24 Jun 2010
- Last updated
- 21 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Quality of Life Outcomes in Cancer Patients Receiving Home Parenteral
- ClinicalTrials.gov ID
- NCT01152879
- Acronym / sponsor ID
- SRMC 10-03
- Conditions
- Cancer
- Keywords
- Parenteral Nutrition, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Southwestern Regional Medical CenterUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 29 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home Parenteral Nutrition | – | Dietary Supplement: Home Parenteral NutritionPatients receiving home parenteral nutrition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home Parenteral NutritionAlso: Intravenous nutritionCancer Patients who are discharged on HPN will be monitored for quality of life, nutrition status, pain and nausea medication usage | Dietary supplement | Home Parenteral Nutrition |
Primary outcome
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
1 secondary outcome
Pain and nausea medication usage
Time frame: Monthly for a minumum of 3 months to a maximum of 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ross Taylor, MD principal investigator
Cancer Treatment Centers of America at Southwestern Regional Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Southwestern Regional Medical Center at 1 site in United States.
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 2 inclusion and 3 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 Feb 2014. 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 United States. 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?
Quality of Life (time frame: Monthly for a minimum of 3 months to a maximum of 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2014.