NCT04376437

The Kinetics of Endocannabinoids in Patients With Chemotherapy Induced Peripheral Neuropathy by Using Medical Cannabis.

The Kinetics of Endocannabinoids in Patients With Chemotherapy Induced Peripheral Neuropathy by Using a Portable Metered-Dose Cannabis Inhaler

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: HaEmek Medical Center, Israel · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Chemotherapy-induced peripheral neuropathy (CIPN) is the most common neurological cancer treatment complication. Medical cannabis is indicated in Israel for the treatment of chronic pain, spasticity and for the control of pain and other symptoms in patients with cancer. The proposed study aims are to study about the changes in level of endocannabinoids following continuous exposure to phytocannabinoids and about the long-term effect of medical cannabis on CIPN.

Detailed description

This will be a self-titrated, open-label design study. Subjects who begin taxanes or oxaliplatine therapy and were diagnosed with CIPN will be recruited to the study. After providing their written informed consent, the study physician obtained a medical history, demographic details and conducted a physical examination. During the current study, baseline period for CIPN evaluation will be 2 weeks, while patients will fill several questionnaires. Baseline CIPN will be evaluating by DN4 and BPI questionnaires. EQ-5D and PSQI will be filled for baseline Quality of life (QOL) and sleepiness status, accordingly.

Conditions

• Chemotherapy-induced Peripheral Neuropathy

Interventions

Type	Name	Description
DRUG	medical cannabis	inhalation by using a Portable Metered-Dose Cannabis Inhaler

Timeline

• Start date: 2022-03-15
• Primary completion: 2022-12-01
• Completion: 2023-12-01
• First posted: 2020-05-06
• Last updated: 2022-03-16

Locations

1 site across 1 country: Israel