L-CARnitine in the palliative treatment of advanced PANcreatic cancer (CARPAN)
| ISRCTN | ISRCTN83465351 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83465351 |
| Secondary identifying numbers | N/A |
- Submission date
- 24/03/2011
- Registration date
- 12/04/2011
- Last edited
- 17/05/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Markus Lerch
Scientific
Scientific
Department of Medicine A
University Medicine Greifswald
Friedrich Löffler Straße 23a
Greifswald
17475
Germany
Study information
| Study design | Placebo controlled double blinded randomised prospective multicentre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | L-Carnitine in the palliative treatment of advanced pancreatic cancer (CARPAN): a prospective, randomised, placebo controlled, double blinded, multicentre trial |
| Study acronym | CARPAN |
| Study objectives | 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, International Union Against Cancer Classification (UICC) Stage IV . |
| Ethics approval(s) | Ethics Commission for the Medical Faculty of the University of Greifswald approved on 30.11.2005, ref no: UV 73/05 |
| Health condition(s) or problem(s) studied | Advanced pancreatic cancer |
| Intervention | Intervention (Verum): L-Carnitine 4 g/day Placebo: Tartaric acid Both administered orally The trial duration was 3 month, patient visit at time of enrolment, week 6 and week 12 |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | L-Carnitine |
| Primary outcome measure | Influence of L-Carnitine on proinflammatory cytokine tumor necrosis factor (TNF)-alpha |
| Secondary outcome measures | 1. Influence of L-Carnitine on 1.1. Other proinflammatory cytokines (IL 6, IL8, IL12) 1.2. C-reactive protein (CRP) 1.3. Malnutrition and cancer cachexia, cancer related fatigue syndrome 1.4. Mortality 1.5. Hospital stay |
| Overall study start date | 01/06/2006 |
| Completion date | 31/10/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 90 patients |
| Key inclusion criteria | 1. Advanced pancreatic cancer (UICC Stage IV) 2. A Karnofsky Index larger than 60 3. Compliance 4. The consent to participate in the study |
| Key exclusion criteria | 1. Patients were excluded with a Child-Pugh classification of liver failure greater than Class B 2. A known second malignant tumor 3. Oral or parenteral supplementation with omega-3-fatty acids 4. Treatment with Thalidomide or Infliximab 5. Mental or physical disorders |
| Date of first enrolment | 01/06/2006 |
| Date of final enrolment | 31/10/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
Department of Medicine A
Greifswald
17475
Germany
17475
Germany
Sponsor information
University Medicine Greifswald (Germany)
University/education
University/education
Department of Medicine A
University Medicine Greifswald
Friedrich Löffler Straße 23a
Greifswald
17475
Germany
"ROR" |
https://ror.org/00r1edq15 |
|---|
Funders
Funder type
University/education
University Medicine Greifswald (Germany) - Department of Medicine A
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
