Enteral NutritionNCT01025167
The Effect of a New Specific Enteral Formula Compared to a Standard Formula on the Tolerability of a Combined Radio- and Chemotherapy in Cancer Patients
A study testing Supportan(R) (Disease-specific enteral tube feed, food for special medical purposes) and Fresubin(R) in people with Enteral Nutrition, run by Fresenius Kabi at 10 sites in Germany.
Trial summary
The purpose of the study is to determine the impact of a specific nutrition formula with a high content of eicosapentaenoic acid (EPA) and fat in oncology patients receiving radio-/chemotherapy on body weight, body composition, nutritional status and physical function compared to a standard nutrition formula. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enteral Nutrition
- What is being tested?
- Supportan(R) (Disease-specific enteral tube feed, food for special medical purposes) and Fresubin(R)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 10 sitesGermany
- Study dates
- Sep 2006to Jan 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with head \& neck cancer or oesophagus cancer,
- enteral nutrition with PEG at least for 14 weeks,
- cancer patients who receive a combined radio-/chemotherapy,
- start of nutritional therapy latest at beginning of the radio-/chemotherapy, body mass index >=16 and <=30 kg/m2,0
- Kondrup Score>=3 or SGA = B/C,
- life expectancy > 6 months,
- written informed consent.
Who cannot join
- second active carcinoma,
- severe diarrhea unresponsive to codeine/loperamide,
- positive anti-HIV-test (safety reasons),
- pregnant or lactating women,
- insulin-dependent diabetes mellitus type I and II,
- patients with cardiac pacemaker,
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- allergy to contents of the investigational product, to milk protein or to fish oil,
- patient has no PEG,
- participation in concurrent clinical studies with any other investigational nutritional therapy within one months prior to start of the study,
- intake of muscle growth supportan substances (e.g. anabolics),
- additional fish oil or EPA substitution within the last 4 weeks, SGA status A (well nourished).
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Germany10 sites
Zentrum für Strahlentherapie und Radioonkologie, Ärztehaus am DIAKO
Bremen, D-28239
Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Universitätsklinikum Dresden
Dresden, D-01307
Department of Radiotherapy, University hospital
Erlangen, D-91054
Klinik für Strahlentherapie und Radioonkologie, Universitätsklinikum Frankfurt
Frankfurt, D-60590
Abteilung Strahlentherapie und Radioonkologie, Universitätsmedizin Göttingen
Göttingen, D-37075
Klinik für Strahlentherapie, Universitätsklinikum Halle
Halle, D-06097
Klinik für Strahlentherapie und Radioonkologie, Universitätsklinikum des Saarlandes
Homburg (Saar), D-66421
Klinik und Poliklinik für Strahlentherapie Universität Rostock
Rostock, D-18059
Abteilung Strahlentherapie und Radioonkologie, Universitätsmedizin Tübingen
Tübingen, D-72076
Klinik für Strahlentherapie und Radioonkologie, Universitätsklinikum Ulm
Ulm, D-89081
About this study
The purpose of the study is to determine the impact of a specific nutrition formula with a high content of eicosapentaenoic acid (EPA) and fat in oncology patients receiving radio-/chemotherapy on body weight, body composition, nutritional status and physical function compared to a standard nutrition formula. Using an adaptive design approximately 80 patients will be randomized in the first part of the study. Following an interim analysis further 160 patients may be added, for a total of 240 patients.
- Conditions
- Enteral Nutrition
- Being tested
- Supportan(R) (Disease-specific enteral tube feed, food for special medical purposes), Fresubin(R)
- Keywords
- cancer, enteral nutrition, omega-3-fatty acids
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportan(R) (Disease-specific enteral tube feed, food for special medical purposes)Dietary supplement
500 ml per day / treatment period 11-14 weeks
Fresubin(R)Dietary supplement
500 ml/a nutritionally complete enteral standard feed (isoenergetic)
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Supportan(R) (500 ml)/disease-specific enteral tube feed for oncologic patients with special key substrates Receives: Dietary Supplement: Supportan(R) (Disease-specific enteral tube feed, food for special medical purposes) |
| Control | Placebo comparator | Fresubin(R) energy fibre (500 ml)/a nutritionally complete enteral standard feed (isoenergetic) Receives: Dietary Supplement: Fresubin(R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body cell mass measured by bioelectrical impedance spectroscopy (BIS)
Measured: Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period
Secondary outcomes (4)
Other parameters of body composition such as fat free mass, lipid mass, total body water, intracellular water, lean tissue mass
Measured: Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period
Hand grip strength
Measured: Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period
Quality of Life
Measured: Baseline, end of radio-/chemotherapy, day 49 of convalescence period
Gastrointestinal tolerance
Measured: Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period, daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startSep 2006
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Enteral NutritionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Rainer Fietkau, Prof. Dr., Principal investigator, Department of Radiotherapy University hospital of Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025167
- Sponsor's protocol ID
- N-SUP-09-DE
- Status last verified
- Aug 2010
- First submitted
- 2 Dec 2009
- Last updated
- 20 Aug 2010
- Results posted
- No
Publications
Fietkau R, Lewitzki V, Kuhnt T, Holscher T, Hess CF, Berger B, Wiegel T, Rodel C, Niewald M, Hermann RM, Lubgan D. A disease-specific enteral nutrition formula improves nutritional status and functional performance in patients with head and neck and esophageal cancer undergoing chemoradiotherapy: results of a randomized, controlled, multicenter trial. Cancer. 2013 Sep 15;119(18):3343-53. doi: 10.1002/cncr.28197. Epub 2013 Jun 13.
PubMed 23765693
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a New Specific Enteral Formula Compared to a Standard Formula on the Tolerability of a Combined Radio- and Chemotherapy in Cancer Patients
- ClinicalTrials.gov ID
- NCT01025167
- Acronym / sponsor ID
- N-SUP-09-DE
- Conditions
- Enteral Nutrition
- Keywords
- cancer, enteral nutrition, omega-3-fatty acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Fresenius KabiIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 3 Dec 2009 (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 purpose of the study is to determine the impact of a specific nutrition formula with a high content of eicosapentaenoic acid (EPA) and fat in oncology patients receiving radio-/chemotherapy on body weight, body composition, nutritional status and physical function compared to a standard nutrition formula. Using an adaptive design approximately 80 patients will be randomized in the first part of the study. Following an interim analysis further 160 patients may be added, for a total of 240 patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Dietary Supplement: Supportan(R) (Disease-specific enteral tube feed, food for special medical purposes)Supportan(R) (500 ml)/disease-specific enteral tube feed for oncologic patients with special key substrates |
| Control | Placebo comparator | Dietary Supplement: Fresubin(R)Fresubin(R) energy fibre (500 ml)/a nutritionally complete enteral standard feed (isoenergetic) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- patients with head \& neck cancer or oesophagus cancer,
- enteral nutrition with PEG at least for 14 weeks,
- cancer patients who receive a combined radio-/chemotherapy,
- start of nutritional therapy latest at beginning of the radio-/chemotherapy, body mass index >=16 and <=30 kg/m2,0
- Kondrup Score>=3 or SGA = B/C,
Key exclusion criteria (11 listed)
- second active carcinoma,
- severe diarrhea unresponsive to codeine/loperamide,
- positive anti-HIV-test (safety reasons),
- pregnant or lactating women,
- insulin-dependent diabetes mellitus type I and II,
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 |
|---|---|---|
| Supportan(R) (Disease-specific enteral tube feed, food for special medical purposes)500 ml per day / treatment period 11-14 weeks | Dietary supplement | Test |
| Fresubin(R)500 ml/a nutritionally complete enteral standard feed (isoenergetic) | Dietary supplement | Control |
Primary outcome
Body cell mass measured by bioelectrical impedance spectroscopy (BIS)
Time frame: Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period
4 secondary outcomes
Other parameters of body composition such as fat free mass, lipid mass, total body water, intracellular water, lean tissue mass
Time frame: Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period
Hand grip strength
Time frame: Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period
Quality of Life
Time frame: Baseline, end of radio-/chemotherapy, day 49 of convalescence period
Gastrointestinal tolerance
Time frame: Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period, daily
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2010.
- Derived from this study: PubMed 23765693Fietkau R, Lewitzki V, Kuhnt T, Holscher T, Hess CF, Berger B, Wiegel T, Rodel C, Niewald M, Hermann RM, Lubgan D. A disease-specific enteral nutrition formula improves nutritional status and functional performance in patients with head and neck and esophageal cancer undergoing chemoradiotherapy: results of a randomized, controlled, multicenter trial. Cancer. 2013 Sep 15;119(18):3343-53. doi: 10.1002/cncr.28197. Epub 2013 Jun 13.
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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.
Rainer Fietkau, Prof. Dr. principal investigator
Department of Radiotherapy University hospital of Erlangen
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportan(R) (Disease-specific enteral tube feed, food for special medical purposes) and Fresubin(R) in people with Enteral Nutrition, run by Fresenius Kabi at 10 sites in Germany.
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 7 inclusion and 11 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: finished, as of the sponsor's last update on 20 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body cell mass measured by bioelectrical impedance spectroscopy (BIS) (time frame: Baseline, mid of radio-/chemotherapy, end of radio-/chemotherapy, day 28 of convalescence period, day 49 of convalescence period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01025167, which also lists 1 linked publication.
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 20 Aug 2010; AzTrials last refreshed its copy on 6 Nov 2026.