An interventional study of medical cannabis in Chemotherapy-induced Peripheral Neuropathy, sponsored by HaEmek Medical Center, Israel. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-03-16.
Sponsored by HaEmek Medical Center, Israel · Not applicable, Interventional, and Basic science
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.
1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.
Browse Peripheral Nervous System Diseases studies →HaEmek Medical Center, Israel is the lead sponsor of 228 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Age above 18 years and below 80 years old. 2. Pathology of Breast or GI malignancies. 3. Treatment with Taxans (Taxol/ Taxotere) or Oxaliplatin for adjuvant treatment or metastatic disease.
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN. 9. Patients who suffer from pain although using a stable analgesic treatment' at least 14 days before entering the trial (no limitation for the use of the analgesic).
Exclusion Criteria:
Use of cannabis or synthetic cannabinoids in the last two weeks (urine test for cannabinoids are positive).
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
Also known as: medical marijuana
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
Plan to share: No
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Peripheral Nervous System Diseases→
HaEmek Medical Center, Israel