L-CARnitine in the Palliative Treatment of Advanced PANcreatic Cancer (CARPAN)

University Medicine Greifswald

Status and phase: Suspended; Phase 3

Conditions: Pancreatic Carcinoma

Treatments: Dietary Supplement: Placebo; Dietary Supplement: L-Carnitine

Study type: Interventional

Funder types: Other

Identifiers

NCT01330823

CARPAN-01

Details and patient eligibility

About

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 .

Full 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

Enrollment: 72 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• advanced pancreatic cancer (UICC Stage IV)
• Karnofsky Index larger than 60
• compliance
• consent to participate to the study

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

72 participants in 2 patient groups, including a placebo group

L-Carnitine

Active Comparator group

Description:

L-Carnitine 4 g daily for Intervention

Treatment:

Dietary Supplement: L-Carnitine

Placebo

Placebo Comparator group

Description:

Placebo (tartaric acid)

Treatment:

Dietary Supplement: Placebo