The Effect of Cannabis in Pancreatic Cancer

Phase 2

Withdrawn

• Conditions: Neoplasms Pancreatic; Cachexia; Cancer; Cannabis; Appetite Loss; Palliative Medicine; Morbidity; Mortality
• Interventions: Drug: THC and CBD Mixture

• Registration Number: NCT03245658
• Lead Sponsor: Jens Rikardt Andersen

Brief Summary

Cannabinoids are known to increase appetite, but THC components have psychogenic properties too. CBD is the main component in the plant, and have only minimal psychogenic effects. The aim was to test the appetite stimulating effects of CBD in patients with pancreatic cancer in palliative treatment.

Detailed Description

Randomization of consecutive patients who wanted to participate to a daily dose of CBD or not as a supplement to the standard treatment.

Study Timeline

• Study First Submitted: 2017-03-21
• Study First Submitted QC: 2017-08-09
• Study First Posted: 2017-08-10
• Study Start: 2017-10-06
• Primary Completion: 2018-05-06
• Study Completion: 2018-10-06
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-11
• Last Update Posted: 2023-12-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Adult, palliative pancreatic cancer diagnosis, weight loss > 5%, understand and read Danish.

Exclusion Criteria

• Regular use of cannabis, psychiatric disorders, alcohol abuse, life expectancy < 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
THC and CBD Mixture	THC and CBD Mixture	32 patients with palliative pancreatic cancer, intervention with oral drops of THC, 25mg/ml and CBD 50mg/ml, daily administered for 4 weeks

Primary Outcome Measures

Name	Time	Method
Energy and protein intake	The outcome measure will be assessed at day 0 and at week 4	Dietary history (% of estimated needs - NRS 2002)

Secondary Outcome Measures

Name	Time	Method
Lean body mass	The outcome measure will be assessed at day 0 and at week 4	Bioimpedance (% of body weight, kg)
Appetite 1	The outcome measure will be assessed at day 0 and at week 4	VAS (cm on 10 cm scale)
Appetite 2	The outcome measure will be assessed at day 0 and at week 4	Dietary history (VAS (cm on 10 cm scale))
Appetite 3	The outcome measure will be assessed at day 0 and at week 4	EORTC QLQ-C30 (score, standard for the Quality of Life entity)
Appetite 4	The outcome measure will be assessed at day 0 and at week 4	EORTC QLQ-PAN26 (score, standard for the Quality of Life entity)
Quality of life 1	The outcome measure will be assessed at day 0 and at week 4	EORTC QLQ-C30 (score, standard for the Quality of Life entity)
Quality of life 2	The outcome measure will be assessed at day 0 and at week 4	EORTC QLQ-PAN26 (score, standard for the Quality of Life entity)
Quality of life 3	The outcome measure will be assessed at day 0 and at week 4	VAS (VAS (cm on 10 cm scale))
Pain 1	The outcome measure will be assessed at day 0 and at week 4	EORTC QLQ-C30 (score, standard for the Quality of Life entity)
Pain 2	The outcome measure will be assessed at day 0 and at week 4	EORTC QLQ-PAN26 (score, standard for the Quality of Life entity)
Pain 3	The outcome measure will be assessed at day 0 and at week 4	VAS (VAS (cm on 10 cm scale))
Mortality (8 weeks)	8 weeks	Patient records, national register

Trial Locations

Locations (1)

Department of clinical oncology, Næstved-Roskilde Hospital; 🇩🇰 Naestved, Denmark