Chemotherapy-induced Peripheral NeuropathyNCT04376437
The Kinetics of Endocannabinoids in Patients With Chemotherapy Induced Peripheral Neuropathy by Using Medical Cannabis.
A study testing medical cannabis in people with Chemotherapy-induced Peripheral Neuropathy, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- medical cannabis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Mar 2022to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. 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.
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 1. Use of cannabis or synthetic cannabinoids in the last two weeks (urine test for cannabinoids are positive).
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Kinetics of Endocannabinoids in Patients With Chemotherapy Induced Peripheral Neuropathy by Using a Portable Metered-Dose Cannabis Inhaler
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.
Read the 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.
- Being tested
- medical cannabis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical cannabisDrug
Also called medical marijuana
inhalation by using a Portable Metered-Dose Cannabis Inhaler
| Study group | Role | What they receive |
|---|---|---|
| medical cannabis | Experimental | 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. Receives: Drug: medical cannabis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the level of 150 different endocannabinoids.
Circulating endocannabinoids concentrations .
Measured: Determined on blood samples collected during the 4 months of participation in the study
Secondary outcomes (3)
Changes from the baseline of neuropathic pain during medical cannabis treatment .
Neuropathic pain detected by DN4 questionnaire .
Measured: 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
Measured: 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.
Measured: This exam will be performed every visit.during 4 months of participation in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start15 Mar 2022 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Collaborators
- Technion, Israel Institute of Technology, Syqe Medical
- Responsible party
- Principal investigator, Gil Bar Sela, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376437
- Sponsor's protocol ID
- ENDO-CIPN 1
- Status last verified
- Mar 2022
- First submitted
- 31 Oct 2019
- Last updated
- 16 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25119581Hammack 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.
PubMed 12098632Mitchell 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.
PubMed 16945171Rao 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.
PubMed 18428211Abrams DI, Jay CA, Shade SB, Vizoso H, Reda H, Press S, Kelly ME, Rowbotham MC, Petersen KL. Cannabis in painful HIV-associated sensory neuropathy: a randomized placebo-controlled trial. Neurology. 2007 Feb 13;68(7):515-21. doi: 10.1212/01.wnl.0000253187.66183.9c.
PubMed 17296917Ellis RJ, Toperoff W, Vaida F, van den Brande G, Gonzales J, Gouaux B, Bentley H, Atkinson JH. Smoked medicinal cannabis for neuropathic pain in HIV: a randomized, crossover clinical trial. Neuropsychopharmacology. 2009 Feb;34(3):672-80. doi: 10.1038/npp.2008.120. Epub 2008 Aug 6.
PubMed 18688212Ware MA, Wang T, Shapiro S, Robinson A, Ducruet T, Huynh T, Gamsa A, Bennett GJ, Collet JP. Smoked cannabis for chronic neuropathic pain: a randomized controlled trial. CMAJ. 2010 Oct 5;182(14):E694-701. doi: 10.1503/cmaj.091414. Epub 2010 Aug 30.
PubMed 20805210Andreae MH, Carter GM, Shaparin N, Suslov K, Ellis RJ, Ware MA, Abrams DI, Prasad H, Wilsey B, Indyk D, Johnson M, Sacks HS. Inhaled Cannabis for Chronic Neuropathic Pain: A Meta-analysis of Individual Patient Data. J Pain. 2015 Dec;16(12):1221-1232. doi: 10.1016/j.jpain.2015.07.009. Epub 2015 Sep 9.
PubMed 26362106Boychuk DG, Goddard G, Mauro G, Orellana MF. The effectiveness of cannabinoids in the management of chronic nonmalignant neuropathic pain: a systematic review. J Oral Facial Pain Headache. 2015 Winter;29(1):7-14. doi: 10.11607/ofph.1274.
PubMed 25635955Lynch ME, Campbell F. Cannabinoids for treatment of chronic non-cancer pain; a systematic review of randomized trials. Br J Clin Pharmacol. 2011 Nov;72(5):735-44. doi: 10.1111/j.1365-2125.2011.03970.x.
PubMed 21426373Pascual D, Goicoechea C, Suardiaz M, Martin MI. A cannabinoid agonist, WIN 55,212-2, reduces neuropathic nociception induced by paclitaxel in rats. Pain. 2005 Nov;118(1-2):23-34. doi: 10.1016/j.pain.2005.07.008. Epub 2005 Oct 4.
PubMed 16213089Rahn 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.
PubMed 17572696Grotenhermen F. Pharmacokinetics and pharmacodynamics of cannabinoids. Clin Pharmacokinet. 2003;42(4):327-60. doi: 10.2165/00003088-200342040-00003.
PubMed 12648025Eisenberg 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.
PubMed 25118789Zusman SP, Lustig JP, Bin Nun G. Cost evaluation of two methods of post tooth extraction hemostasis in patients on anticoagulant therapy. Community Dent Health. 1993 Jun;10(2):167-73.
PubMed 8402303
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Kinetics of Endocannabinoids in Patients With Chemotherapy Induced Peripheral Neuropathy by Using a Portable Metered-Dose Cannabis Inhaler
- ClinicalTrials.gov ID
- NCT04376437
- Acronym / sponsor ID
- ENDO-CIPN 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Collaborators
- Technion, Israel Institute of Technology, Syqe Medical
- Study start
- 15 Mar 2022 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 6 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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 .
| Arm | Type | Receives |
|---|---|---|
| medical cannabis | Experimental | Drug: medical cannabisAll 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1. 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.
- 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.
- 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.
Key exclusion criteria (10 listed)
- 1. Use of cannabis or synthetic cannabinoids in the last two weeks (urine test for cannabinoids are positive).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medical cannabisAlso: medical marijuanainhalation by using a Portable Metered-Dose Cannabis Inhaler | Drug | medical cannabis |
Primary outcome
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 .
3 secondary outcomes
Changes from the baseline of neuropathic pain during medical cannabis treatment .
Time frame: during 4 months of participation in the study
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 in Quality of life by BPI
Time frame: This exam will be performed every visit.during 4 months of participation in the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Results publication: PubMed 25119581Pachman 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.
- Results publication: PubMed 12098632Hammack 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.
- Results publication: PubMed 16945171Mitchell 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.
- Results publication: PubMed 18428211Rao 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.
- Results publication: PubMed 17296917Abrams DI, Jay CA, Shade SB, Vizoso H, Reda H, Press S, Kelly ME, Rowbotham MC, Petersen KL. Cannabis in painful HIV-associated sensory neuropathy: a randomized placebo-controlled trial. Neurology. 2007 Feb 13;68(7):515-21. doi: 10.1212/01.wnl.0000253187.66183.9c.
- Results publication: PubMed 18688212Ellis RJ, Toperoff W, Vaida F, van den Brande G, Gonzales J, Gouaux B, Bentley H, Atkinson JH. Smoked medicinal cannabis for neuropathic pain in HIV: a randomized, crossover clinical trial. Neuropsychopharmacology. 2009 Feb;34(3):672-80. doi: 10.1038/npp.2008.120. Epub 2008 Aug 6.
- Results publication: PubMed 20805210Ware MA, Wang T, Shapiro S, Robinson A, Ducruet T, Huynh T, Gamsa A, Bennett GJ, Collet JP. Smoked cannabis for chronic neuropathic pain: a randomized controlled trial. CMAJ. 2010 Oct 5;182(14):E694-701. doi: 10.1503/cmaj.091414. Epub 2010 Aug 30.
- Results publication: PubMed 26362106Andreae MH, Carter GM, Shaparin N, Suslov K, Ellis RJ, Ware MA, Abrams DI, Prasad H, Wilsey B, Indyk D, Johnson M, Sacks HS. Inhaled Cannabis for Chronic Neuropathic Pain: A Meta-analysis of Individual Patient Data. J Pain. 2015 Dec;16(12):1221-1232. doi: 10.1016/j.jpain.2015.07.009. Epub 2015 Sep 9.
- Results publication: PubMed 25635955Boychuk DG, Goddard G, Mauro G, Orellana MF. The effectiveness of cannabinoids in the management of chronic nonmalignant neuropathic pain: a systematic review. J Oral Facial Pain Headache. 2015 Winter;29(1):7-14. doi: 10.11607/ofph.1274.
- Results publication: PubMed 21426373Lynch ME, Campbell F. Cannabinoids for treatment of chronic non-cancer pain; a systematic review of randomized trials. Br J Clin Pharmacol. 2011 Nov;72(5):735-44. doi: 10.1111/j.1365-2125.2011.03970.x.
- Results publication: PubMed 16213089Pascual D, Goicoechea C, Suardiaz M, Martin MI. A cannabinoid agonist, WIN 55,212-2, reduces neuropathic nociception induced by paclitaxel in rats. Pain. 2005 Nov;118(1-2):23-34. doi: 10.1016/j.pain.2005.07.008. Epub 2005 Oct 4.
- Results publication: PubMed 17572696Rahn 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.
- Individual participant dataSharing planned: No
Related trials for Chemotherapy-induced Peripheral Neuropathy
Active, not recruiting
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
Not yet recruiting
Continuous Controlled Cooling for Prevention of Chemotherapy-Induced Peripheral Neuropathy
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy
Not yet recruiting
The Effect of Aerobic and Resistance Training With and Without Neurodynamic Exercises on Chemotherapy-induced Peripheral Neuropathy Symptoms and Associated Neuro-immune Mechanisms
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingEarly Phase 1
Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients, Metastatic Colorectal Cancer (CRC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing medical cannabis in people with Chemotherapy-induced Peripheral Neuropathy, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gil Bar Sela, Prof (+97250-206-1207, gil_ba@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the level of 150 different endocannabinoids. (time frame: Determined on blood samples collected during the 4 months of participation in the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04376437, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.