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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
40
inhalation by using a Portable Metered-Dose Cannabis Inhaler
Haemek MC
Afula, North, Israel
Changes in the level of 150 different endocannabinoids.
Circulating endocannabinoids concentrations .
Time frame: Determined on blood samples collected during the 4 months of participation in the study
Changes from the baseline of neuropathic pain during medical cannabis treatment .
Neuropathic pain detected by DN4 questionnaire .
Time frame: during 4 months of participation in the study
Changes in Quality of life by FACT-GOG-Ntx
Changes of Quality of life will be evaluated by Functional Assessment of Cancer Therapy - Gynecologic Oncology Group-Neurotoxicity ( FACT-GOG-Ntx) questionnaire
Time frame: This exam will be performed every visit.during 4 months of participation in the study
Changes in Quality of life by BPI
Changes of Quality of life will be evaluated by BRIEF PAIN INVENTORY (BPI) tool.
Time frame: This exam will be performed every visit.during 4 months of participation in the study
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