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Topical Cannabidiol for the Treatment of Chemotherapy-Induced Peripheral Neuropathy

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ClinicalTrials.gov Identifier: NCT05388058
Recruitment Status : Recruiting
First Posted : May 24, 2022
Last Update Posted : March 24, 2023
Sponsor:
Information provided by (Responsible Party):
Mayo Clinic

Study Description
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Brief Summary:
This clinical trial compares topical cannabidiol to placebo in improving chemotherapy-induced peripheral neuropathy, or painful sensations in your hands or feet due to chemotherapy. Peripheral neuropathy is a nerve problem that causes pain, numbness, tingling, swelling, or muscle weakness in different parts of the body. It usually begins in the hands or feet and gets worse over time. Peripheral neuropathy caused by chemotherapy is called chemotherapy-induced peripheral neuropathy (CIPN). CIPN is commonly seen in patients receiving certain chemotherapy medications and is hard to treat. Medications commonly used to treat CIPN have limited benefits and may cause significant side effects. A small report showed that topical cannabidiol may help treat neuropathy in patients with diabetes. This study is being done to determine if cannabidiol cream can help improve the symptoms of CIPN.

Condition or disease Intervention/treatment Phase
Chemotherapy-Induced Peripheral Neuropathy Malignant Solid Neoplasm Drug: Cannabidiol Drug: Placebo Administration Other: Quality-of-Life Assessment Other: Questionnaire Administration Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate whether topical cannabidiol (CBD) improves CIPN, compared to placebo.

II. To evaluate side effects from topical CBD cream use, compared to placebo.

SECONDARY OBJECTIVES:

I. Other measures of neuropathy as measured by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) CIPN20 motor subscale, the EORTC QLQ CIPN20 autonomic scale, and the total Common Terminology Criteria for Adverse Events (CTCAE) neuropathy scale.

II. Adverse event profiles will also be assessed using symptom questionnaires and CTCAE version (v)5.0.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients apply cannabidiol cream topically to affected areas twice daily (BID) for 14 days. Patients then apply placebo cream topically to affected areas BID for 14 days.

ARM II: Patients apply placebo cream topically to affected areas BID for 14 days. Patients then apply cannabidiol cream topically to affected areas BID for 14 days.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Topical Cannabidiol (CBD) for the Treatment of Chemotherapy-Induced Peripheral Neuropathy: A Randomized Placebo-Controlled Pilot Trial
Actual Study Start Date : June 9, 2022
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : April 1, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Cannabidiol

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I (cannabidiol, placebo)
Patients apply cannabidiol cream topically to affected areas BID for 14 days. Patients then apply placebo cream topically to affected areas BID for 14 days.
 Drug: Cannabidiol
Applied topically
Other Names:
  • CBD
  • CBD Oil
  • Epidiolex
  • GWP42003-P

Drug: Placebo Administration
Applied topically

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies
Experimental: Arm II (placebo, cannabidiol)
Patients apply placebo cream topically to affected areas BID for 14 days. Patients then apply cannabidiol cream topically to affected areas BID for 14 days.
 Drug: Cannabidiol
Applied topically
Other Names:
  • CBD
  • CBD Oil
  • Epidiolex
  • GWP42003-P

Drug: Placebo Administration
Applied topically

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. Change in chemotherapy-induced peripheral neuropathy (CIPN) [ Time Frame: Baseline to end of week 2 ]
    CIPN will be measured by the sensory subscale of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-CIPN20 which is composed of 9 individual items. Will be compared between arms using two-sample, two-sided t-tests. The cannabidiol arm will be compared to the placebo arm. Will construct 95% confidence intervals for the mean difference in sensory neuropathy score between arms. Repeated measures mixed models will be applied to the sensory scores over all time points to determine longitudinal effects and to adjust for confounding factors. Graphical results will include profile plots over time, stream plots of individual changes over time, and forest plots of the 95% confidence intervals by arm.


Secondary Outcome Measures :
  1. Change in EORTC QLQ CIPN20 motor subscale [ Time Frame: Baseline to end of week 2 ]
    Will be compared between arms using two-sample, two-sided t-tests. The cannabidiol arm will be compared to the placebo arm. Will construct 95% confidence intervals for the mean difference in sensory neuropathy score between arms. Repeated measures mixed models will be applied to the sensory scores over all time points to determine longitudinal effects and to adjust for confounding factors. Graphical results will include profile plots over time, stream plots of individual changes over time, and forest plots of the 95% confidence intervals by arm.

  2. Change in EORTC QLQ CIPN20 autonomic scale [ Time Frame: Baseline to end of week 2 ]
    Will be compared between arms using two-sample, two-sided t-tests. The cannabidiol arm will be compared to the placebo arm. Will construct 95% confidence intervals for the mean difference in sensory neuropathy score between arms. Repeated measures mixed models will be applied to the sensory scores over all time points to determine longitudinal effects and to adjust for confounding factors. Graphical results will include profile plots over time, stream plots of individual changes over time, and forest plots of the 95% confidence intervals by arm.

  3. Total Common Terminology Criteria for Adverse Events (CTCAE) neuropathy scale [ Time Frame: Up to 14 days ]
    Will compare the incidence and maximum (worst) values between arms. Fisher's exact tests will be used to compare incidence rates and Wilcoxon rank-sum tests will be used to compare maximum values between arms.

  4. Incidence of adverse events [ Time Frame: Up to 28 days ]
    Will be assessed using symptom questionnaires and CTCAE version 5.0. Will compare the incidence and maximum (worst) values between arms. Fisher's exact tests will be used to compare incidence rates and Wilcoxon rank-sum tests will be used to compare maximum values between arms.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >= 18 years
  • English speaking
  • Cancer diagnosis of any tumor type with chemotherapy-induced neuropathy
  • At least 4 out of 10 severity of neuropathy pain and/or tingling
  • Stable for at least 7 days prior to registration on medications for neuropathy, if any are being used
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2

  • Negative pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only

    • NOTE: If a urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  • Able to provide written informed consent
  • Ability to complete questionnaire(s) by themselves or with assistance
  • No evidence of residual cancer
  • Platelet count > 100,000/mm^3 (following completion of chemotherapy)
  • Absolute neutrophil count (ANC) >= 1,000/mm^3 (following completion of chemotherapy)
  • Hemoglobin > 11 g/dL (following completion of chemotherapy)
  • Serum transaminase (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) =< 1.2 x upper limit of normal (ULN) (following completion of chemotherapy)
  • Alkaline phosphatase =< 1.2 x ULN (following completion of chemotherapy)
  • Serum creatinine =< 1.2 x ULN (following completion of chemotherapy)

Exclusion Criteria:

  • Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:

    • Pregnant persons
    • Nursing persons
    • Persons of childbearing potential who are unwilling to employ adequate contraception
  • Any medical condition that would prohibit use of a topical cream (skin infection or open wound in the area of the neuropathy)
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • Pre-existing neuropathy prior to chemotherapy that would confuse the issue of CIPN
  • Currently on chemotherapy or received chemotherapy treatment within the prior 3 months
  • Use of other cannabis products within 30 days prior to registration
  • History of allergy to cannabis products
Contacts and Locations
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Information from the National Library of Medicine

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): NCT05388058


Locations
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United States, Minnesota
Mayo Clinic Health System Albert Lea Recruiting
Albert Lea, Minnesota, United States, 56007
Contact: Mina Hanna, M.D.    612-624-2620    ccinfo@umn.edu   
Principal Investigator: Mina Hanna, M.D.         
Fairview Grand Itasca Clinic and Hospital Recruiting
Grand Rapids, Minnesota, United States, 55744
Contact: Anastas Provatas, M.D.    612-624-2620    ccinfo@umn.edu   
Principal Investigator: Anastas Provatas, M.D.         
Fairview Range Medical Center Recruiting
Hibbing, Minnesota, United States, 55746
Contact: Anastas Provatas, M.D.    612-624-2620    ccinfo@umn.edu   
Principal Investigator: Anastas Provatas, M.D.         
Mayo Clinic Health System Mankato Recruiting
Mankato, Minnesota, United States, 56001
Contact: Stephan Thome, M.D.    612-624-2620    ccinfo@umn.edu   
Monticello Cancer Center Recruiting
Monticello, Minnesota, United States, 55362
Contact: Yan Ji, M.D.    612-624-2620    ccinfo@umn.edu   
Fairview Northland Medical Center Recruiting
Princeton, Minnesota, United States, 55371
Contact: Anastas Provatas, M.D.    612-624-2620    ccinfo@umn.edu   
Principal Investigator: Anastas Provatas, M.D.         
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trial Referral Office    855-776-0015    mayocliniccancerstudies@mayo.edu   
Principal Investigator: Stacy D. D'Andre, M.D.         
Sanford Thief River Falls Recruiting
Thief River Falls, Minnesota, United States, 56701
Contact: Amit Panwalker, M.D.    612-624-2620    ccinfo@umn.edu   
Sanford Worthington Recruiting
Worthington, Minnesota, United States, 56187
Contact: Jonathan Bleeker, M.D.    612-624-2620    ccinfo@umn.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Stacy D D'Andre Mayo Clinic in Rochester
More Information
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Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT05388058    
Other Study ID Numbers: MC211003
NCI-2022-02479 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: May 24, 2022    Key Record Dates
Last Update Posted: March 24, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cannabidiol
Anticonvulsants