Prevention of Cancer-associated Malnutrition Through Oral Nutritional Supplements

Cancer Clinical Trial

Official title:

Prevention of Malnutrition Through Oral Nutritional Supplements in Cancer Patients Receiving Palliative Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02312674
• Other study ID #: ZEM_Minigrad_TN
• Status: Not yet recruiting
• Phase: N/A
• First received: November 7, 2014
• Last updated: December 8, 2014
• Start date: January 2015
• Est. completion date: January 2016

Study information

• Verified date: November 2014
• Source: University of Hohenheim
• Contact: Stephan C. Bischoff, MD, Prof.
• Phone: 0049 711 45924101
• Email: bischoff.stephan[@]uni-hohenheim.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The aim of the randomized controlled study is to determine effects of an adjusted amount of oral nutritional supplements on the quality of life, the nutritional status, side effects, and response to therapy, in patients with pancreatic and hepatocellular carcinoma receiving palliative therapy.

Description:

Cancer is often associated with malnutrition and weight loss. The occurence of malnutrition during the course of the disease depends on the type, extent, and therapy of the tumor. Pancreatic cancer patients and patients with hepatocellular carcinoma are particularly at risk of developing a pronounced weight loss. Cancer-related malnutrition has negative impact on the response to therapy, survival, quality of life, and the infection rate of patients, resulting in prolonged hospital stays and higher costs for health care. Maintaining or optimizing the quality of life in patients receiving palliative therapy has priority. Since a poor nutritional status affects the quality of life, patients might benefit from the use of an adjusted amount of oral nutritional supplements.

To determine the effects of oral nutritional supplements, a controlled randomized study will be conducted.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• assured diagnosis of pancreatic cancer/hepatocellular carcinoma, not treatable with curative intent

• palliative systemic therapy of pancreatic cancer respectively palliative therapy of hepatocellular carcinoma with Sorafenib or TACE (transarterial chemoembolization)

• written informed consent prior to inclusion

Exclusion Criteria:

• prefinal phase with an estimated life expectancy of less than three months

• nutritional support through tube feeding or a central venous catheter

• serious malassimilation (assessed by anamnesis)

• Eastern Cooperative Oncology Group (ECOG) Performance Status = 2

• hepatic encephalopathy = degree 2

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cancer
• Malnutrition

Intervention

Dietary Supplement:
• Oral nutritional supplement
Beginning with the start of palliative therapy, depending on the nutritional status, one, two, or three cans per day are ingested during a period of three months.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Hohenheim	University Hospital Tuebingen

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Average daily energy intake [kcal]	To assess the average daily energy intake patients keep a food diary over two days between the trial dates	Every four weeks for a period of three months and after six months	No
Other	Side effect profile	The occurrence and extent of tumor-associated and nutritional therapy-associated side effects are determined using Common Terminology Criteria for Adverse Events (CTCAE)	Every four weeks for a period of three months and after six months	No
Other	Dose density	The dose density is determined by the intended and actual administered respectively ingested dose of medication. The dose density is taken from the chemotherapy protocols or determined based on taking notes.	After three months	No
Other	Tumor response	In patients with pancreatic cancer tumor staging is performed based on the Response Evaluation Criteria in Solid Tumors (RECIST criteria), in patients with hepatocellular carcinoma tumor staging is performed based on the modified RECIST criteria	After three months	No
Primary	Change in health-related quality of life	Health-related quality of life is assessed by using the standardized questionnaire "Short Form-36 Health Survey" (SF36).	Every four weeks for a period of three months and after six months	No
Primary	Change in disease-related quality of life	Disease-related quality of life is assessed by using the standardized questionnaire "Functional Assessment of Cancer Therapy - Hepatobiliary questionaire" (FACT-Hep).	Every four weeks for a period of three months and after six months	No
Secondary	Body mass index (BMI)	To calculate the BMI, weight and height are measured.	Every four weeks for a period of three months and after six months	No
Secondary	Body composition	To measure the body composition, a bioelectrical impedance analysis (BIA) is carried out. The phase angle and the extracellular cell mass/body cell mass ratio (ECM/BCM ratio) is evaluated.	Every four weeks for a period of three months and after six months	No
Secondary	Grip strength [lb]	To measure the grip strength, a hydraulic force measuring device is used.	Every four weeks for a period of three months and after six months	No
Secondary	Score (points) of nutritional risk screening	Patients are screened with the Nutritional Risk Screening 2002 (NRS 2002)	Every four weeks for a period of three months and after six months	No
Secondary	Laboratory parameters	Albumin, C-reactive protein (CRP), Ferritin are measured to assess the nutritional and protein status as well as the disease activity	Every four weeks for a period of three months and after six months	No