Study of Parenteral Nutrition to Patients With Gastrointestinal Cancer

Quality of Life Clinical Trial

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 Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02066363
• Other study ID #: HPN 01
• Status: Terminated
• Phase: N/A
• First received: February 14, 2014
• Last updated: October 4, 2017
• Start date: March 1, 2014
• Est. completion date: August 30, 2017

Study information

• Verified date: October 2017
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. completion date: August 30, 2017
• Est. primary completion date: August 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Body Composition, Beneficial
• Cachexia
• Cancer Cachexia
• Dietary Modification
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Quality of Life

Intervention

Dietary Supplement:
• Dietician advise
Dietician advise 5 times, during 24weeks. Prescription of a diet plan if wanted from the patient.
• Parenteral nutrition
Supportive parenteral nutrition.

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (9)

Lead Sponsor	Collaborator
Odense University Hospital	Aase and Ejnar Danielsens Foundation, Baxter Healthcare Corporation, Brødrene Hartmanns Fond, Danish Cancer Society, Knud and Edith Eriksen Memorial Fund, Merchant M. Brogaard and Wife Memorial fund, OPEN, Odense Patient data Explorative Network, OUH, Region of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	frequency of readmission to the Hospital	Number of admissions	6 months
Other	Survival in study	Time to event; survival time in study	6 months
Primary	Changes in body composition	Measured by using bioelectrical impedance analysis.	Six months
Secondary	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)	six months