The Kinetics of Endocannabinoids in Patients With Chemotherapy Induced Peripheral Neuropathy by Using Medical Cannabis.
NCT ID: NCT04376437
Last Updated: 2022-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2022-03-15
2023-12-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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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.
medical cannabis
inhalation by using a Portable Metered-Dose Cannabis Inhaler
Interventions
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medical cannabis
inhalation by using a Portable Metered-Dose Cannabis Inhaler
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
4\. Estimated life expectancy ≥ 6 months. 5. Performance status ≤1 (ECOG classification). 6. Sign of written informed consent. 7. CIPN is examined during the chemotherapy treatment DN4 score must be above 4 (and by physician decision) for more than one week.
8\. Patient with adequate liver/renal function at screening as described:
* Creatinine clearance \>30 ml/min as calculated by Cockcroft-Gault Equation.
* 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).
10\. Patient possessed a valid license from the Israeli Ministry of Health to receive medicinal cannabis.
11\. Patient is able and willing to comply with study requirements. 12. Patient agrees to use only medical cannabis provided by study team until the end of study period.
13\. Patient has not undergone major surgery in the month prior to the study start.
14\. Patient agrees not to participate in other interventional clinical trial during the study participation.
Exclusion Criteria
2\. Patient with known or past substance abuse. 3. Patients with major psychiatric disorders (e.g. schizophrenia, dementia, and intellectual disabilities).
4\. Patients with first degree siblings under the age of 30 years old with psychiatric disorders.
5\. Patients with uncontrolled diabetes mellitus, cardiovascular, or convulsive disorders according to investigator.
6\. Patients with sensitivity to cannabis or cannabinoids. 7. Patients with known neuropathic pain due to diabetes or other diseases. 8. Patients with severe respiratory disease. 9. Patients with brain metastases or brain tumors may participate if completed radiotherapy treatment at least 14 days prior to signing the informed consent and last imaging did not show any worsening.
10\. Female subjects who are pregnant, lactating, or want to get pregnant during the study period and one month following the study. Male subjects who want their partner to get pregnant during the study period and one month following the study.
11\. Females of childbearing potential or males whose partners with childbearing potential and did not use adequate contraceptives 28 days prior to study start or during the study.
12\. Other life-threatening medical conditions that disqualify the patient from participating in the study, according to the Primary Investigator's judgment.
13\. Anticipated alcohol or barbiturate use during the study period. 14. Participation in other clinical trials during the last month. 15. Subjects who are using one of the following medications: opiates (Primidone, Phenobarbitol, Arbamazepine, Rifampicin, Rifabutin, Troglitazone and Hypericum perforatum).
16\. Patient who has undergone a major surgery a month prior to study start.
18 Years
80 Years
ALL
No
Sponsors
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Technion, Israel Institute of Technology
OTHER
Syqe Medical
INDUSTRY
HaEmek Medical Center, Israel
OTHER
Responsible Party
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Gil Bar Sela
Oncologist
Locations
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Haemek MC
Afula, North, Israel
Countries
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Central Contacts
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References
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Pachman DR, Watson JC, Loprinzi CL. Therapeutic strategies for cancer treatment related peripheral neuropathies. Curr Treat Options Oncol. 2014 Dec;15(4):567-80. doi: 10.1007/s11864-014-0303-7.
Hammack JE, Michalak JC, Loprinzi CL, Sloan JA, Novotny PJ, Soori GS, Tirona MT, Rowland KM Jr, Stella PJ, Johnson JA. Phase III evaluation of nortriptyline for alleviation of symptoms of cis-platinum-induced peripheral neuropathy. Pain. 2002 Jul;98(1-2):195-203. doi: 10.1016/s0304-3959(02)00047-7.
Mitchell PL, Goldstein D, Michael M, Beale P, Friedlander M, Zalcberg J, White S, Thomson JA, Clarke S. Addition of gabapentin to a modified FOLFOX regimen does not reduce oxaliplatin-induced neurotoxicity. Clin Colorectal Cancer. 2006 Jul;6(2):146-51. doi: 10.3816/CCC.2006.n.032.
Rao RD, Flynn PJ, Sloan JA, Wong GY, Novotny P, Johnson DB, Gross HM, Renno SI, Nashawaty M, Loprinzi CL. Efficacy of lamotrigine in the management of chemotherapy-induced peripheral neuropathy: a phase 3 randomized, double-blind, placebo-controlled trial, N01C3. Cancer. 2008 Jun 15;112(12):2802-8. doi: 10.1002/cncr.23482.
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Rahn EJ, Makriyannis A, Hohmann AG. Activation of cannabinoid CB1 and CB2 receptors suppresses neuropathic nociception evoked by the chemotherapeutic agent vincristine in rats. Br J Pharmacol. 2007 Nov;152(5):765-77. doi: 10.1038/sj.bjp.0707333. Epub 2007 Jun 18.
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Eisenberg E, Ogintz M, Almog S. The pharmacokinetics, efficacy, safety, and ease of use of a novel portable metered-dose cannabis inhaler in patients with chronic neuropathic pain: a phase 1a study. J Pain Palliat Care Pharmacother. 2014 Sep;28(3):216-25. doi: 10.3109/15360288.2014.941130. Epub 2014 Aug 13.
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La Porta C, Bura SA, Llorente-Onaindia J, Pastor A, Navarrete F, Garcia-Gutierrez MS, De la Torre R, Manzanares J, Monfort J, Maldonado R. Role of the endocannabinoid system in the emotional manifestations of osteoarthritis pain. Pain. 2015 Oct;156(10):2001-2012. doi: 10.1097/j.pain.0000000000000260.
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Berman P, Futoran K, Lewitus GM, Mukha D, Benami M, Shlomi T, Meiri D. A new ESI-LC/MS approach for comprehensive metabolic profiling of phytocannabinoids in Cannabis. Sci Rep. 2018 Sep 24;8(1):14280. doi: 10.1038/s41598-018-32651-4.
Vulfsons S, Ognitz M, Bar-Sela G, Raz-Pasteur A, Eisenberg E. Cannabis treatment in hospitalized patients using the SYQE inhaler: Results of a pilot open-label study. Palliat Support Care. 2020 Feb;18(1):12-17. doi: 10.1017/S147895151900021X.
Other Identifiers
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ENDO-CIPN 1
Identifier Type: -
Identifier Source: org_study_id
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