Pancreatic CarcinomaPhase 3CARPANNCT01330823
L-CARnitine in the Palliative Treatment of Advanced PANcreatic Cancer (CARPAN)
A Phase 3 study testing L-Carnitine in people with Pancreatic Carcinoma, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
The study investigated the role of L-Carnitine supplementation on proinflammatory immune response, malnutrition, cancer cachexia and cancer related fatigue in advanced and inoperable pancreatic cancer, UICC Stage IV . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatic Carcinoma
- What is being tested?
- L-Carnitine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2006to Jul 2010
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- advanced pancreatic cancer (UICC Stage IV)
- Karnofsky Index larger than 60
- compliance
- consent to participate to the study
Who cannot join
- Child-Pugh classification of liver failure greater than Child B,
- a known second malignant tumor
- oral or parenteral supplementation with omega-3-fatty acids
- treatment with thalidomide or Infliximab
- mental or physical disorders
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medicine Greifswald,Department of Medicine A
Greifswald, 17489
About this study
Official title: L-Carnitine in the Palliative Treatment of Advanced Pancreatic Cancer (CARPAN): a Prospective, Randomised, Placebo Controlled, Double Blinded, Multicentre Trial
The study investigated the role of L-Carnitine supplementation on proinflammatory immune response, malnutrition, cancer cachexia and cancer related fatigue in advanced and inoperable pancreatic cancer, UICC Stage IV .
Read the detailed description
Pancreatic cancer has the lowest 5-year survival rate of any cancer and ranks as the fourth leading cause of cancer death world wide. Several metabolic changes are present in the whole body in case of cancer so the investigators conducted a placebo controlled, double blinded, randomized, prospective and multicentre study to investigate, whether L-Carnitine supplementation may have an impact on malnutrition, cancer cachexia and cancer related fatigue in advanced pancreatic cancer.
Study drug: L-Carnitine 4g per day (vers) Placebo Study design: A multi-centre, double blind, and placebo-controlled, randomised, parallel group study
Patient population: Patients with advanced pancreatic carcinoma Number of patients: Total of 90 patients in two equal groups number of centres: 4 (Greifswald, Magdeburg, Berlin,Heidelberg,all Germany) Duration of dosing: 12 weeks
- Conditions
- Pancreatic Carcinoma
- Being tested
- L-Carnitine, Placebo
- Keywords
- pancreatic carcinoma, L-Carnitine, quality of life, survival, malnutrition, cancer cachexia, fatigue
- Medical subject headings
- Pancreatic Neoplasms, Malnutrition, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-CarnitineDietary supplement
L-Carnitine, 4g/day, orally (Juice)
PlaceboDietary supplement
tartaric acid same dose like L-Carnitine as placebo
| Study group | Role | What they receive |
|---|---|---|
| L-Carnitine | Active comparator | L-Carnitine 4 g daily for Intervention Receives: Dietary Supplement: L-Carnitine |
| Placebo | Placebo comparator | Placebo (tartaric acid) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
TNF-alpha
Influence of L-Carnitine on proinflammatory cytokine TNF-alpha
Measured: 12 weeks
Secondary outcomes (4)
nutritional status
Bioelectrical impedance analysis (BIA) was performed,BCM / ECM index, phase angle, body fat was measured. Increase of body weight and body mass index and and also weight loss were investigated.
Measured: 12 weeks
Quality of life
Quality of life was determined using the European EORTC QLQ-C30 form, along with an additional disease specific pancreatic cancer module PAN26 and also Brief Fatique Inventory (BFI).
Measured: 12 weeks
survival
Survival time in days was calculated from time of diagnosis until death.
Measured: 1 year
hospital stay
time of hospital stay
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2011 (estimated)
- Study startJun 2006
- Primary completionOct 2009 (estimated)
- Study completionJul 2010 (estimated)
Why it stopped: after interims analysis standard errors for inflammatory and nutritional markers varied widely, that the power calculation required unattainable goals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CarcinomaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Investigators
- Markus M. Lerch, Prof., Principal investigator, University Medicine Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330823
- Sponsor's protocol ID
- CARPAN-01
- Acronym
- CARPAN
- Status last verified
- Apr 2011
- First submitted
- 5 Apr 2011
- Last updated
- 7 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L-Carnitine in the Palliative Treatment of Advanced Pancreatic Cancer (CARPAN): a Prospective, Randomised, Placebo Controlled, Double Blinded, Multicentre Trial
- ClinicalTrials.gov ID
- NCT01330823
- Acronym / sponsor ID
- CARPAN / CARPAN-01
- Conditions
- Pancreatic Carcinoma
- Keywords
- pancreatic carcinoma, L-Carnitine, quality of life, survival, malnutrition, cancer cachexia, fatigue
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: after interims analysis standard errors for inflammatory and nutritional markers varied widely, that the power calculation required unattainable goals
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 7 Apr 2011 (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 study investigated the role of L-Carnitine supplementation on proinflammatory immune response, malnutrition, cancer cachexia and cancer related fatigue in advanced and inoperable pancreatic cancer, UICC Stage IV .
Detailed description
Pancreatic cancer has the lowest 5-year survival rate of any cancer and ranks as the fourth leading cause of cancer death world wide. Several metabolic changes are present in the whole body in case of cancer so the investigators conducted a placebo controlled, double blinded, randomized, prospective and multicentre study to investigate, whether L-Carnitine supplementation may have an impact on malnutrition, cancer cachexia and cancer related fatigue in advanced pancreatic cancer.
Study drug: L-Carnitine 4g per day (vers) Placebo Study design: A multi-centre, double blind, and placebo-controlled, randomised, parallel group study
Patient population: Patients with advanced pancreatic carcinoma Number of patients: Total of 90 patients in two equal groups number of centres: 4 (Greifswald, Magdeburg, Berlin,Heidelberg,all Germany) Duration of dosing: 12 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-Carnitine | Active comparator | Dietary Supplement: L-CarnitineL-Carnitine 4 g daily for Intervention |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo (tartaric acid) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- advanced pancreatic cancer (UICC Stage IV)
- Karnofsky Index larger than 60
- compliance
- consent to participate to the study
Key exclusion criteria (5 listed)
- Child-Pugh classification of liver failure greater than Child B,
- a known second malignant tumor
- oral or parenteral supplementation with omega-3-fatty acids
- treatment with thalidomide or Infliximab
- mental or physical disorders
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 |
|---|---|---|
| L-CarnitineL-Carnitine, 4g/day, orally (Juice) | Dietary supplement | L-Carnitine |
| Placebotartaric acid same dose like L-Carnitine as placebo | Dietary supplement | Placebo |
Primary outcome
TNF-alpha
Time frame: 12 weeks
Influence of L-Carnitine on proinflammatory cytokine TNF-alpha
4 secondary outcomes
nutritional status
Time frame: 12 weeks
Quality of life
Time frame: 12 weeks
survival
Time frame: 1 year
hospital stay
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2011.
- Related InfoLink provided by the sponsor.
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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.
Markus M. Lerch, Prof. principal investigator
University Medicine Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing L-Carnitine in people with Pancreatic Carcinoma, run by University Medicine Greifswald at 1 site 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 4 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: paused, as of the sponsor's last update on 7 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
TNF-alpha (time frame: 12 weeks). 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 7 Apr 2011; AzTrials last refreshed its copy on 8 Nov 2026.