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Study of Parenteral Nutrition to Patients With Gastrointestinal Cancer

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Baxter Healthcare Corporation
Region Southern Denmark
Information provided by (Responsible Party):
SObling, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT02066363
First received: February 14, 2014
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

Clinical background: Weight loss is a common problem in patients suffering from upper 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 Parenteral Nutrition.

Design: This study is a controlled, randomized trial with two parallel study arms. The study will include patients with advanced upper 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.


Condition Intervention
Gastrointestinal Cancer
Dietary Modification
Cancer Cachexia
Quality of Life
Body Composition, Beneficial
Dietary Supplement: Dietician advise
Dietary Supplement: Parenteral nutrition

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Changes in body composition [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Measured by using bioelectrical impedance analysis.


Secondary Outcome Measures:
  • Time to to exacerbate Quality of Life [ Time Frame: six months ] [ Designated as safety issue: No ]
    Assessment of quality of life by European Organization for Research and Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ30)


Other Outcome Measures:
  • frequency of readmission to the Hospital [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 2014
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Best nutritional Care
Best supportive nutritional care and dietician advise
Dietary Supplement: Dietician advise
Dietician advise 5 times, during 24weeks. Prescription of a diet plan if wanted from the patient.
Other Name: Best supportive Nutritional care,
Experimental: Parenteral nutrition
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.
Dietary Supplement: Dietician advise
Dietician advise 5 times, during 24weeks. Prescription of a diet plan if wanted from the patient.
Other Name: Best supportive Nutritional care,
Dietary Supplement: Parenteral nutrition
Supportive parenteral nutrition.

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 and1 in opposite to PS 2.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed non-resectable upper 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

Exclusion Criteria:

  • Gastrointestinal obstruction or failure.
  • Immune deficiency diseases (apart from the cancer disease. )
  • Current infection or sepsis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02066363

Locations
Denmark
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Baxter Healthcare Corporation
Region Southern Denmark
Investigators
Study Director: Jens Kjeldsen, ph.d Odense University Hospital
  More Information

No publications provided

Responsible Party: SObling, Registrar, ph.d student, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02066363     History of Changes
Other Study ID Numbers: HPN 01
Study First Received: February 14, 2014
Last Updated: April 9, 2014
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by Odense University Hospital:
Bioelectrical impedance
Parenteral nutrition
Malnutrition
Quality of life.
Cancer cachexia
Body composition

Additional relevant MeSH terms:
Cachexia
Gastrointestinal Neoplasms
Body Weight
Body Weight Changes
Digestive System Diseases
Digestive System Neoplasms
Emaciation
Gastrointestinal Diseases
Neoplasms
Neoplasms by Site
Signs and Symptoms
Weight Loss

ClinicalTrials.gov processed this record on November 25, 2014