Study of Parenteral Nutrition to Patients With Gastrointestinal Cancer

• Sponsor: Odense University Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02066363
• Collaborator: Baxter Healthcare Corporation (Industry), Region of Southern Denmark (Other), Danish Cancer Society (Other), Aase and Ejnar Danielsens Foundation (Other), Hartmann Fonden (Other), Knud and Edith Eriksen Memorial Fund (Other), Merchant M. Brogaard and Wife Memorial fund (Other), Odense Patient Data Explorative Network (Other)
• Enrollment: 47
• Location: 1
• Arms: 2
• Duration (Months): 42
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Cancer; Dietary Modification; Cancer Cachexia; Quality of Life; Body Composition, Beneficial	Dietary Supplement: Dietician advise; Dietary Supplement: Parenteral nutrition	N/A

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

• Study Type: Interventional
• Actual Enrollment: 47 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Aug 30, 2017
• Actual Study Completion Date: Aug 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Best supportive Nutritional care, ; Dietary Supplement: Parenteral nutrition; Supportive parenteral nutrition.

Outcome Measures

Primary Outcome Measures

1. Changes in body composition [Six months]

   Measured by using bioelectrical impedance analysis.

Secondary Outcome Measures

1. Time to to exacerbate Quality of Life [six months]

   Assessment of quality of life by European Organization for Research and Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ30)

Other Outcome Measures

1. frequency of readmission to the Hospital [6 months]

   Number of admissions

2. Survival in study [6 months]

   Time to event; survival time in study

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• Gastrointestinal obstruction or failure.

• Immune deficiency diseases (apart from the cancer disease. )

• Current infection or sepsis.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Odense University Hospital	Odense		Denmark	5000

Sponsors and Collaborators

• Odense University Hospital
• 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

Investigators

• Study Director: Jens Kjeldsen, ph.d, Odense University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sine Obling, MD, Registrar, ph.d student, Odense University Hospital
• ClinicalTrials.gov Identifier: NCT02066363
• Other Study ID Numbers: HPN 01
• First Posted: Feb 19, 2014
• Last Update Posted: Oct 5, 2017
• Last Verified: Oct 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Keywords provided by Sine Obling, MD, Registrar, ph.d student, Odense University Hospital: Bioelectrical impedance; Parenteral nutrition; Malnutrition; Quality of life.; Cancer cachexia; Body composition
• Additional relevant MeSH terms: Gastrointestinal Neoplasms; Wasting Syndrome; Cachexia

Study Results

No Results Posted as of Oct 5, 2017