The Kinetics of Endocannabinoids in Patients With Chemotherapy Induced Peripheral Neuropathy by Using Medical Cannabis.
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|ClinicalTrials.gov Identifier: NCT04376437|
Recruitment Status : Not yet recruiting
First Posted : May 6, 2020
Last Update Posted : July 29, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Chemotherapy-induced Peripheral Neuropathy||Drug: medical cannabis||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Syqe Medical Cannabis inhaler is approval medical device in Israel , this is only Basic science study with main purpose to learn more about the kinetics of endocannabinoids .|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||The Kinetics of Endocannabinoids in Patients With Chemotherapy Induced Peripheral Neuropathy by Using a Portable Metered-Dose Cannabis Inhaler|
|Estimated Study Start Date :||September 1, 2020|
|Estimated Primary Completion Date :||February 1, 2022|
|Estimated Study Completion Date :||February 1, 2023|
Experimental: medical cannabis
All patients will start with 250mcg cannabis flos BID and will follow the titration plan of dose modification according to CIPN relief and adverse events. Maximum dose of 2,000mcg per day is prescribed at the end of titration period, which is continuous for 15 days (about 2 weeks).On 10 weeks visit all patients will be discontinued from the treatment. In case of worsening of neuropathy at any point during the 4 weeks of FU, patients might be able to restart with inhaled MC treatment for no more than 4 weeks. Total treatment in this study will be for no more than 14 weeks.
Drug: medical cannabis
inhalation by using a Portable Metered-Dose Cannabis Inhaler
Other Name: medical marijuana
- Changes in the level of 150 different endocannabinoids. [ Time Frame: Determined on blood samples collected during the 4 months of participation in the study ]Circulating endocannabinoids concentrations .
- Changes from the baseline of neuropathic pain during medical cannabis treatment . [ Time Frame: during 4 months of participation in the study ]Neuropathic pain detected by DN4 questionnaire .
- Changes in Quality of life by FACT-GOG-Ntx [ Time Frame: This exam will be performed every visit.during 4 months of participation in the study ]Changes of Quality of life will be evaluated by Functional Assessment of Cancer Therapy - Gynecologic Oncology Group-Neurotoxicity ( FACT-GOG-Ntx) questionnaire
- Changes in Quality of life by BPI [ Time Frame: This exam will be performed every visit.during 4 months of participation in the study ]Changes of Quality of life will be evaluated by BRIEF PAIN INVENTORY (BPI) tool.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04376437
|Contact: Gil Bar Sela, Proffirstname.lastname@example.org|
|Contact: Ela Lutwak, M.SCemail@example.com|
|Afula, North, Israel|