NCT02312674

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable cancer

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 9, 2014

Completed
23 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

December 9, 2014

Status Verified

November 1, 2014

Enrollment Period

1 year

First QC Date

November 7, 2014

Last Update Submit

December 8, 2014

Conditions

Cancer

Keywords

pancreatic carcinomahepatocellular carcinomapalliative therapyoral nutritional supplementsquality of lifenutritional status

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (5)

  • Body mass index (BMI)

    Every four weeks for a period of three months and after six months

  • Body composition

    Every four weeks for a period of three months and after six months

  • Grip strength [lb]

    Every four weeks for a period of three months and after six months

  • Score (points) of nutritional risk screening

    Every four weeks for a period of three months and after six months

  • Laboratory parameters

    Every four weeks for a period of three months and after six months

Other Outcomes (4)

  • Average daily energy intake [kcal]

    Every four weeks for a period of three months and after six months

  • Side effect profile

    Every four weeks for a period of three months and after six months

  • Dose density

    After three months

  • +1 more other outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Patient group which takes daily an adjusted amount of oral nutritional supplements through an intervention period of three months

Dietary Supplement: Oral nutritional supplement

Control

NO INTERVENTION

Patients group which takes no oral nutritional supplements

Interventions

Oral nutritional supplementDIETARY_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.

Also known as: Fortimel Compact/Fortimel Compact Fibre, Nutricia
Intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

NeoplasmsPancreatic NeoplasmsCarcinoma, Hepatocellular

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeLiver NeoplasmsLiver Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Stephan C. Bischoff, MD, Prof.

    Department of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany

    PRINCIPAL INVESTIGATOR

  • Michael Bitzer, MD; Prof.

    Department of Hepatology, Gastroenterology, Infectious Diseases, University Hospital Tübingen

    STUDY DIRECTOR

Central Study Contacts

Stephan C. Bischoff, MD, Prof.

CONTACT

0049 711 45924101bischoff.stephan@uni-hohenheim.de

Janna Jayme

CONTACT

janna.jayme@uni-hohenheim.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2014

First Posted

December 9, 2014

Study Start

January 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

December 9, 2014

Record last verified: 2014-11