CachexiaNCT00852020
Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in Chronic Heart Failure and Chronic Obstructive Pulmonary Disease Patients
A study testing oral nutrition supplement, food for special medical purposes in people with Cachexia and Chronic Obstructive Pulmonary Disease, run by Fresenius Kabi at 4 sites in 2 countries.
Trial summary
To test the compliance, tolerance, safety and to get preliminary insights into the efficacy of a new oral nutritional supplement (containing n-3 fatty acids, amino acids and antioxidants) designed to prevent or delay cachexia and anorexia in patients with chronic heart failure (CHF) or chronic obstructive pulmonary… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cachexia, Chronic Obstructive Pulmonary Disease, Chronic Heart Failure
- What is being tested?
- oral nutrition supplement, food for special medical purposes
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Apr 2009to Apr 2011
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of CHF or COPD
- current body weight less than 6 months ago
- BMI >=20 and <=30 kg/m2
- CHF: LVEF >=45% measured within the past 6 months
- symptom status equivalent to NYHA class II to IV
- biochemical abnormalities for total cholesterol, serum uric acid, abnormal high CRP
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- on standard therapy of CHF including ACE inhibitors and beta blockers
- COPD: symptom status equivalent to GOLD standard class II to IV
- FEV1 < 80%
- FEV1/FEV < 70%
Who cannot join
- significant oedema in the time of screening and randomisation
- concomitant inflammatory diseases
- active infections including HIV and AIDS
- liver failure
- chronic renal failure (sCr>1.5mg/dL) or cardiac pacemaker
- acute or chronic infections
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- insulin treated diabetes mellitus
- patient with established diagnosis of cachexia
- life expectancy of less than 6 months in the opinion of the investigator
- medications that impair sex hormone synthesis, secretion or function
- patients with psychiatric diseases
- body weight loss > 5% during the last 6 months or > 10% during the last 10 months
- suspected allergy to any component of the investigational product(s)
- fish oil supplementation within 3 months prior to the study entry
- taking vitamin supplements in doses greater than the Recommended Daily Allowances
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany2 sites
Center of Cachexia Research, Department of Cardiology, Charité, Campus Virchow-Klinikum
Berlin, D-13353
Praxis für Pneumologie, Schwedt/Oder
Schwedt, D-16303
Poland2 sites
Regionalne Centrum Leczenia Chorób Płuc i Alergii, NZOZ ALLMED
Piekary Śląskie, PL-41-940
Specjalista Chorób Wewnętrznych Kardiolog
Ruda Śląska, PL-41-709
About this study
Official title: Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in CHF and COPD Patients. A Randomised, Double-blind and Controlled Pilot Study.
To test the compliance, tolerance, safety and to get preliminary insights into the efficacy of a new oral nutritional supplement (containing n-3 fatty acids, amino acids and antioxidants) designed to prevent or delay cachexia and anorexia in patients with chronic heart failure (CHF) or chronic obstructive pulmonary disease (COPD).
- Being tested
- oral nutrition supplement, food for special medical purposes
- Medical subject headings
- Cachexia, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral nutrition supplement, food for special medical purposesDietary supplement
2 servings of 200-300 ml per day, treatment period: 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | oral nutritional supplement containing n-3-fatty acids, amino acids and antioxidants Receives: Dietary Supplement: oral nutrition supplement, food for special medical purposes |
| 2 | Placebo comparator | oral nutritional supplement (isocaloric, isonitrogenous) Receives: Dietary Supplement: oral nutrition supplement, food for special medical purposes |
What is being measured
The primary outcome is the main question the study is designed to answer.
compliance to nutrition therapy
Measured: baseline, months 1, 2, 3, 4
Secondary outcomes (6)
anorexia questionnaire
Measured: baseline, months 1, 2, 3, 4
Gastrointestinal syndrome score (GIS)
Measured: baseline, months 1, 2, 3, 4
body cell mass
Measured: baseline, months 1, 2, 3, 4
weight change
Measured: baseline, months 1, 2, 3, 4
hand grip strength
Measured: baseline, months 1, 2, 3, 4
patient global assessment (PGA)
Measured: baseline, months 2, 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CachexiaStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stefan Anker, Prof. MD PHD, Principal investigator, Center of Cachexia Research, Department of Cardiology, Charité Campus Virchow-Klinikum, Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852020
- Sponsor's protocol ID
- PCSU-002-CFS
- Status last verified
- Jan 2017
- First submitted
- 13 Feb 2009
- Last updated
- 31 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerance and Efficacy of an Oral Nutritional Supplement in CHF and COPD Patients. A Randomised, Double-blind and Controlled Pilot Study.
- ClinicalTrials.gov ID
- NCT00852020
- Acronym / sponsor ID
- PCSU-002-CFS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fresenius KabiIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 26 Feb 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.
To test the compliance, tolerance, safety and to get preliminary insights into the efficacy of a new oral nutritional supplement (containing n-3 fatty acids, amino acids and antioxidants) designed to prevent or delay cachexia and anorexia in patients with chronic heart failure (CHF) or chronic obstructive pulmonary disease (COPD).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: oral nutrition supplement, food for special medical purposesoral nutritional supplement containing n-3-fatty acids, amino acids and antioxidants |
| 2 | Placebo comparator | Dietary Supplement: oral nutrition supplement, food for special medical purposesoral nutritional supplement (isocaloric, isonitrogenous) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- diagnosis of CHF or COPD
- current body weight less than 6 months ago
- BMI >=20 and <=30 kg/m2
- CHF: LVEF >=45% measured within the past 6 months
- symptom status equivalent to NYHA class II to IV
Key exclusion criteria (15 listed)
- significant oedema in the time of screening and randomisation
- concomitant inflammatory diseases
- active infections including HIV and AIDS
- liver failure
- chronic renal failure (sCr>1.5mg/dL) or cardiac pacemaker
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 nutrition supplement, food for special medical purposes2 servings of 200-300 ml per day, treatment period: 16 weeks | Dietary supplement | 1, 2 |
Primary outcome
compliance to nutrition therapy
Time frame: baseline, months 1, 2, 3, 4
6 secondary outcomes
anorexia questionnaire
Time frame: baseline, months 1, 2, 3, 4
Gastrointestinal syndrome score (GIS)
Time frame: baseline, months 1, 2, 3, 4
body cell mass
Time frame: baseline, months 1, 2, 3, 4
weight change
Time frame: baseline, months 1, 2, 3, 4
hand grip strength
Time frame: baseline, months 1, 2, 3, 4
patient global assessment (PGA)
Time frame: baseline, months 2, 4
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 31 Jan 2017.
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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.
Stefan Anker, Prof. MD PHD principal investigator
Center of Cachexia Research, Department of Cardiology, Charité Campus Virchow-Klinikum, Berlin
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral nutrition supplement, food for special medical purposes in people with Cachexia and Chronic Obstructive Pulmonary Disease, run by Fresenius Kabi at 4 sites in 2 countries.
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 10 inclusion and 15 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 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Poland. 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?
compliance to nutrition therapy (time frame: baseline, months 1, 2, 3, 4). 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 31 Jan 2017.