Gastrointestinal CancerNCT02066363
Study of Parenteral Nutrition to Patients With Gastrointestinal Cancer
A study testing Dietician advise and Parenteral nutrition in people with Gastrointestinal Cancer and Dietary Modification, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Clinical background: Weight loss is a common problem in patients suffering from gastrointestinal cancer. It is demonstrated that the prognosis for cancer patients with weight loss is worse than that for weight stable patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancer, Dietary Modification, Cancer Cachexia
- What is being tested?
- Dietician advise and Parenteral nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2014to 30 Aug 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed non-resectable GI-Cancer
- at nutritional risk; having lost 5% of body weight during the previous 3 months or has failed to reach intake by 25% in the last 2 weeks.
- At performance status 0-2
- Life expectancy more than 3 months.
- Age over 18 years old.
- Able to give written consent
Who cannot join
- Gastrointestinal obstruction or failure.
- Immune deficiency diseases (apart from the cancer disease. )
- Current infection or sepsis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Best Nutritional Care in Cancer Patients. A Comparative Randomized Study of Supplemental Parenteral Nutrition to Patients With GI Cancer Compared to Best Supportive Nutritional Care
Clinical background: Weight loss is a common problem in patients suffering from gastrointestinal cancer. It is demonstrated that the prognosis for cancer patients with weight loss is worse than that for weight stable patients. Malnutrition in cancer patients is associated with a poor prognosis and is an important predictor of mortality. Supplementation with home parenteral nutrition in aphagic and terminal patients has shown improved quality of life, energy balance, body composition and prolonged survival.
Aim: The aim of this study is primarily to study the effects of supplementation with parenteral nutrition, to patients with advanced incurable gastrointestinal cancer on lean body-mass and body composition. Patients found to be at nutritional risk will be included in the study and will be randomized to either best supportive nutritional care or best supportive nutritional care and supplemental Parenteral Nutrition.
Read more
Design: This study is a controlled, randomized trial with two parallel study arms. The study will include patients with advanced GI cancers at nutritional risk, performance status 0-2 and with an expected survival of a minimum of 3 months.
A total of 100 patients are planned to be enrolled and randomized to either best supportive nutritional care or best supportive nutritional care and supplemental parenteral Nutrition.
Primary endpoint is improvement of lean body mass, and by that improvement of quality of life, performance status and cancer treatment tolerance.
Discussion: The planned study will provide important information about the effect of parenteral nutrition in a patient group with advanced gastrointestinal cancer. Palliative treatment strategies are set up to improve quality of life as well as prolongation of life. Parenteral nutrition in this patient group may indeed contribute to both these aspects of palliation.
Read the detailed description
Randomizing. The patients will be enrolled in the study, by block randomizing using a computer generated list, stratifying in respect to performance status 0 and 1 in opposite to PS 2 for the first 10 patients enrolled in the study.
To make the two treatment groups comparable, the patients number 11-100 enrolled in the study will be placed in the treatment groups using the minimization method. Using the minimization method the prognostic factors for age, diagnosis and performance status at the enrollment, will be considered to make the treatment groups similar.
- Conditions
- Gastrointestinal Cancer, Dietary Modification, Cancer Cachexia, Quality of Life, Body Composition, Beneficial
- Being tested
- Dietician advise, Parenteral nutrition
- Keywords
- Bioelectrical impedance, Parenteral nutrition, Malnutrition, Quality of life., Cancer cachexia, Body composition
- Medical subject headings
- Gastrointestinal Neoplasms, Glucocorticoid Receptor Deficiency, Hyperphagia, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietician adviseDietary supplement
Also called Best supportive Nutritional care,
Dietician advise 5 times, during 24weeks. Prescription of a diet plan if wanted from the patient.
Parenteral nutritionDietary supplement
Supportive parenteral nutrition.
| Study group | Role | What they receive |
|---|---|---|
| Best nutritional Care | Active comparator | Best supportive nutritional care and dietician advise Receives: Dietary Supplement: Dietician advise |
| Parenteral nutrition | Experimental | Supplemental Parenteral Nutrition and dietician advise. Supplemental parenteral Nutrition 30% of estimated needs. Parenteral nutrition given at home, administered by a nurse. The patient will be seen at the Outpatient Clinic every 6th week, talk to dietician and a doctor. Receives: Dietary Supplement: Dietician advise; Dietary Supplement: Parenteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body composition
Measured by using bioelectrical impedance analysis.
Measured: Six months
Secondary outcomes (1)
Time to to exacerbate Quality of Life
Assessment of quality of life by European Organization for Research and Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ30)
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study start1 Mar 2014
- Primary completion30 Aug 2017
- Study completion30 Aug 2017
Why it stopped: Recruitment very time consuming, too few wanting participation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation, Region of Southern Denmark, Danish Cancer Society, Aase and Ejnar Danielsens Foundation, Hartmann Fonden, Knud and Edith Eriksen Memorial Fund, Merchant M. Brogaard and Wife Memorial fund, Odense Patient Data Explorative Network
- Responsible party
- Principal investigator, Sine Obling, MD, Odense University Hospital
- Investigators
- Jens Kjeldsen, ph.d, Study director, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066363
- Sponsor's protocol ID
- HPN 01
- Status last verified
- Oct 2017
- First submitted
- 14 Feb 2014
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Obling SR, Wilson BV, Pfeiffer P, Kjeldsen J. Home parenteral nutrition increases fat free mass in patients with incurable gastrointestinal cancer. Results of a randomized controlled trial. Clin Nutr. 2019 Feb;38(1):182-190. doi: 10.1016/j.clnu.2017.12.011. Epub 2017 Dec 21.
PubMed 29305245
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Best Nutritional Care in Cancer Patients. A Comparative Randomized Study of Supplemental Parenteral Nutrition to Patients With GI Cancer Compared to Best Supportive Nutritional Care
- ClinicalTrials.gov ID
- NCT02066363
- Acronym / sponsor ID
- HPN 01
- Conditions
- Gastrointestinal Cancer, Dietary Modification, Cancer Cachexia, Quality of Life, Body Composition, Beneficial
- Keywords
- Bioelectrical impedance, Parenteral nutrition, Malnutrition, Quality of life., Cancer cachexia, Body composition
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment very time consuming, too few wanting participation
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation, Region of Southern Denmark, Danish Cancer Society, Aase and Ejnar Danielsens Foundation, Hartmann Fonden, Knud and Edith Eriksen Memorial Fund, Merchant M. Brogaard and Wife Memorial fund, Odense Patient Data Explorative Network
- Study start
- 1 Mar 2014
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 19 Feb 2014 (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.
Clinical background: Weight loss is a common problem in patients suffering from gastrointestinal cancer. It is demonstrated that the prognosis for cancer patients with weight loss is worse than that for weight stable patients. Malnutrition in cancer patients is associated with a poor prognosis and is an important predictor of mortality. Supplementation with home parenteral nutrition in aphagic and terminal patients has shown improved quality of life, energy balance, body composition and prolonged survival.
Aim: The aim of this study is primarily to study the effects of supplementation with parenteral nutrition, to patients with advanced incurable gastrointestinal cancer on lean body-mass and body composition. Patients found to be at nutritional risk will be included in the study and will be randomized to either best supportive nutritional care or best supportive nutritional care and supplemental Parenteral Nutrition.
Design: This study is a controlled, randomized trial with two parallel study arms. The study will include patients with advanced GI cancers at nutritional risk, performance status 0-2 and with an expected survival of a minimum of 3 months.
A total of 100 patients are planned to be enrolled and randomized to either best supportive nutritional care or best supportive nutritional care and supplemental parenteral Nutrition.
Primary endpoint is improvement of lean body mass, and by that improvement of quality of life, performance status and cancer treatment tolerance.
Discussion: The planned study will provide important information about the effect of parenteral nutrition in a patient group with advanced gastrointestinal cancer. Palliative treatment strategies are set up to improve quality of life as well as prolongation of life. Parenteral nutrition in this patient group may indeed contribute to both these aspects of palliation.
Detailed description
Randomizing. The patients will be enrolled in the study, by block randomizing using a computer generated list, stratifying in respect to performance status 0 and 1 in opposite to PS 2 for the first 10 patients enrolled in the study.
To make the two treatment groups comparable, the patients number 11-100 enrolled in the study will be placed in the treatment groups using the minimization method. Using the minimization method the prognostic factors for age, diagnosis and performance status at the enrollment, will be considered to make the treatment groups similar.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Best nutritional Care | Active comparator | Dietary Supplement: Dietician adviseBest supportive nutritional care and dietician advise |
| Parenteral nutrition | Experimental | Dietary Supplement: Dietician advise, Dietary Supplement: Parenteral nutritionSupplemental Parenteral Nutrition and dietician advise. Supplemental parenteral Nutrition 30% of estimated needs. Parenteral nutrition given at home, administered by a nurse. The patient will be seen at the Outpatient Clinic every 6th week, talk to dietician and a doctor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed non-resectable GI-Cancer
- at nutritional risk; having lost 5% of body weight during the previous 3 months or has failed to reach intake by 25% in the last 2 weeks.
- At performance status 0-2
- Life expectancy more than 3 months.
- Age over 18 years old.
Key exclusion criteria (3 listed)
- Gastrointestinal obstruction or failure.
- Immune deficiency diseases (apart from the cancer disease. )
- Current infection or sepsis.
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 |
|---|---|---|
| Dietician adviseAlso: Best supportive Nutritional care,Dietician advise 5 times, during 24weeks. Prescription of a diet plan if wanted from the patient. | Dietary supplement | Best nutritional Care, Parenteral nutrition |
| Parenteral nutritionSupportive parenteral nutrition. | Dietary supplement | Parenteral nutrition |
Primary outcome
Changes in body composition
Time frame: Six months
Measured by using bioelectrical impedance analysis.
1 secondary outcome
Time to to exacerbate Quality of Life
Time frame: six months
Results and safety
The study was stopped early (reason given: Recruitment very time consuming, too few wanting participation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2017.
- Derived from this study: PubMed 29305245Obling SR, Wilson BV, Pfeiffer P, Kjeldsen J. Home parenteral nutrition increases fat free mass in patients with incurable gastrointestinal cancer. Results of a randomized controlled trial. Clin Nutr. 2019 Feb;38(1):182-190. doi: 10.1016/j.clnu.2017.12.011. Epub 2017 Dec 21.
- Individual participant dataSharing planned: Undecided
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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.
Jens Kjeldsen, ph.d study director
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietician advise and Parenteral nutrition in people with Gastrointestinal Cancer and Dietary Modification, run by Odense University Hospital at 1 site in Denmark.
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 6 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: stopped early, as of the sponsor's last update on 5 Oct 2017. 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 Denmark. 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 was stopped early (reason given: Recruitment very time consuming, too few wanting participation). Results are not available in the source record.
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?
Changes in body composition (time frame: 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 NCT02066363, which also lists 1 linked publication.
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 5 Oct 2017.