CancerNCT02312674
Prevention of Cancer-associated Malnutrition Through Oral Nutritional Supplements
A study testing Oral nutritional supplement in people with Cancer, run by University of Hohenheim.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer
- What is being tested?
- Oral nutritional supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
Janna Jayme contact
About this study
Official title: Prevention of Malnutrition Through Oral Nutritional Supplements in Cancer Patients Receiving Palliative Therapy
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.
Read the detailed 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.
- Conditions
- Cancer
- Being tested
- Oral nutritional supplement
- Keywords
- pancreatic carcinoma, hepatocellular carcinoma, palliative therapy, oral nutritional supplements, quality of life, nutritional status
- Medical subject headings
- Neoplasms, Pancreatic Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral nutritional supplementDietary supplement
Also called Fortimel Compact/Fortimel Compact Fibre, Nutricia
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patient group which takes daily an adjusted amount of oral nutritional supplements through an intervention period of three months Receives: Dietary Supplement: Oral nutritional supplement |
| Control | No intervention | Patients group which takes no oral nutritional supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Every four weeks for a period of three months and after six months
Secondary outcomes (5)
Body mass index (BMI)
To calculate the BMI, weight and height are measured.
Measured: Every four weeks for a period of three months and after six months
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.
Measured: Every four weeks for a period of three months and after six months
Grip strength [lb]
To measure the grip strength, a hydraulic force measuring device is used.
Measured: Every four weeks for a period of three months and after six months
Score (points) of nutritional risk screening
Patients are screened with the Nutritional Risk Screening 2002 (NRS 2002)
Measured: Every four weeks for a period of three months and after six months
Laboratory parameters
Albumin, C-reactive protein (CRP), Ferritin are measured to assess the nutritional and protein status as well as the disease activity
Measured: Every four weeks for a period of three months and after six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hohenheim
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Tuebingen
- Responsible party
- Sponsor
- Investigators
- Stephan C. Bischoff, MD, Prof., Principal investigator, Department of Nutritional Medicine, University of Hohenheim, Stuttgart, GermanyMichael Bitzer, MD; Prof., Study director, Department of Hepatology, Gastroenterology, Infectious Diseases, University Hospital Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02312674
- Sponsor's protocol ID
- ZEM_Minigrad_TN
- Status last verified
- Nov 2014
- First submitted
- 7 Nov 2014
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Malnutrition Through Oral Nutritional Supplements in Cancer Patients Receiving Palliative Therapy
- ClinicalTrials.gov ID
- NCT02312674
- Acronym / sponsor ID
- ZEM_Minigrad_TN
- Conditions
- Cancer
- Keywords
- pancreatic carcinoma, hepatocellular carcinoma, palliative therapy, oral nutritional supplements, quality of life, nutritional status
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of HohenheimUniversity, hospital or other
- Collaborators
- University Hospital Tuebingen
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 9 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Oral nutritional supplementPatient group which takes daily an adjusted amount of oral nutritional supplements through an intervention period of three months |
| Control | No intervention | –Patients group which takes no oral nutritional supplements |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral nutritional supplementAlso: Fortimel Compact/Fortimel Compact Fibre, NutriciaBeginning 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. | Dietary supplement | Intervention |
Primary outcome
Change in health-related quality of life
Time frame: Every four weeks for a period of three months and after six months
Health-related quality of life is assessed by using the standardized questionnaire "Short Form-36 Health Survey" (SF36).
Change in disease-related quality of life
Time frame: Every four weeks for a period of three months and after six months
Disease-related quality of life is assessed by using the standardized questionnaire "Functional Assessment of Cancer Therapy - Hepatobiliary questionaire" (FACT-Hep).
5 secondary outcomes
Body mass index (BMI)
Time frame: Every four weeks for a period of three months and after six months
Body composition
Time frame: Every four weeks for a period of three months and after six months
Grip strength [lb]
Time frame: Every four weeks for a period of three months and after six months
Score (points) of nutritional risk screening
Time frame: Every four weeks for a period of three months and after six months
Laboratory parameters
Time frame: Every four weeks for a period of three months and after six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janna Jayme contact
Stephan C. Bischoff, MD, Prof. principal investigator
Department of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany
Michael Bitzer, MD; Prof. study director
Department of Hepatology, Gastroenterology, Infectious Diseases, University Hospital Tübingen
Questions about this trial
What is this clinical trial studying?
A study testing Oral nutritional supplement in people with Cancer, run by University of Hohenheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephan C. Bischoff, MD, Prof. (0049 711 45924101, bischoff.stephan@uni-hohenheim.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in health-related quality of life (time frame: Every four weeks for a period of three months and after six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2014.