Efficacy and Safety of Dronabinol in the Improvement of Chemotherapy-induced and Tumor-related Symptoms in Advanced Pancreatic Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

109

Participants

Timeline

Start Date

December 16, 2019

Primary Completion Date

September 25, 2024

Study Completion Date

September 25, 2024

Conditions
Pancreatic Cancer Non-resectableChemotherapy-induced Nausea and VomitingPancreatic Cancer Metastatic
Interventions
DRUG

Dronabinol in Oral Dosage Form

Titration period for 4 weeks: titration according to tolerability from 2.5 mg (3 x 1 droplet) up to 30 mg (3 x 12 droplets) per day; dose increased by 2.5 mg (3 x 1 droplet) every other day Maintenance period for 12 weeks: individually tolerated maximum dose (up to 30 mg ≙ 3 x 12 droplets) at end of titration period will be continued for maintenance treatment Tapering period for 2 weeks: dose is decreased every other day by 5 mg (3 x 2 droplets) Safety follow-up: 4 weeks after end of treatment

DRUG

Placebo in Oral Dosage Form

Titration period for 4 weeks: titration according to tolerability from 3 x 1 droplet up to 3 x 12 droplets per day; dose increased by 3 x 1 droplet every other day Maintenance period for 12 weeks: individually tolerated maximum dose (up to 3 x 12 droplets) at end of titration period will be continued for maintenance treatment Tapering period for 2 weeks: dose is decreased every other day by 3 x 2 droplets Safety follow-up: 4 weeks after end of treatment

Trial Locations (11)

1140

Hanusch Krankenhaus der Wiener Gebietskrankenkasse, Vienna

4600

Klinikum Wels-Grieskirchen GmbH, Abteilung für Innere Medizin IV, Wels

5020

IIIrd Medical Department, Private Medical University Hospital Salzburg, Salzburg

6511

KH Zams, Innere Medizin, Internistische Onkologie u. Haematologie, Zams

8700

LKH Hochsteiermark - Standort Leoben Abteilung für Innere Medizin und Hämatologie und internistische Onkologie, Leoben

9020

KABEG-Klinikum Klagenfurt am Woerthersee, Abteilung f. Anaesthesie u. Intensivmedizin, Klagenfurt

9300

Krankenhaus d. Barmherzigen Brüder, Abt. f. Innere Medizin, Sankt Veit an der Glan

37075

Universitätsmedizin Göttingen Abt. f. Gastroenterologie, gastrointestinale Onkologie u. Endokrinologie, Göttingen

81737

München Klinik Neuperlach, München

A-4400

Pyhrn-Eisenwurzen Klinikum Steyr, Interne Medizin II, Steyr

07199

Marienhospital Onkologie, Hämatologie, Palliativmedizin, Stuttgart

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Medical University of Graz

OTHER

collaborator

Unidata Geodesign

UNKNOWN

collaborator

Bionorica SE

INDUSTRY

lead

Arbeitsgemeinschaft medikamentoese Tumortherapie

OTHER