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Topical Cannabidiol for the Treatment of Chemotherapy-Induced Peripheral Neuropathy

Primary Purpose

Chemotherapy-Induced Peripheral Neuropathy, Malignant Solid Neoplasm

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cannabidiol
Placebo Administration
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chemotherapy-Induced Peripheral Neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic Health System Albert Lea
  • Fairview Grand Itasca Clinic and Hospital
  • Fairview Range Medical Center
  • Mayo Clinic Health System Mankato
  • Monticello Cancer Center
  • Fairview Northland Medical Center
  • Mayo Clinic in Rochester
  • Sanford Thief River Falls
  • Sanford Worthington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I (cannabidiol, placebo)

Arm II (placebo, cannabidiol)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in chemotherapy-induced peripheral neuropathy (CIPN)
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

Change in EORTC QLQ CIPN20 motor subscale
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.
Change in EORTC QLQ CIPN20 autonomic scale
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.
Total Common Terminology Criteria for Adverse Events (CTCAE) neuropathy scale
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.
Incidence of adverse events
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.

Full Information

First Posted
May 19, 2022
Last Updated
June 30, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05388058
Brief Title
Topical Cannabidiol for the Treatment of Chemotherapy-Induced Peripheral Neuropathy
Official Title
Topical Cannabidiol (CBD) for the Treatment of Chemotherapy-Induced Peripheral Neuropathy: A Randomized Placebo-Controlled Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 9, 2022 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-Induced Peripheral Neuropathy, Malignant Solid Neoplasm

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (cannabidiol, placebo)
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm II (placebo, cannabidiol)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cannabidiol
Other Intervention Name(s)
CBD, CBD Oil, Epidiolex, GWP42003-P
Intervention Description
Applied topically
Intervention Type
Drug
Intervention Name(s)
Placebo Administration
Intervention Description
Applied topically
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Change in chemotherapy-induced peripheral neuropathy (CIPN)
Description
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.
Time Frame
Baseline to end of week 2
Secondary Outcome Measure Information:
Title
Change in EORTC QLQ CIPN20 motor subscale
Description
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.
Time Frame
Baseline to end of week 2
Title
Change in EORTC QLQ CIPN20 autonomic scale
Description
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.
Time Frame
Baseline to end of week 2
Title
Total Common Terminology Criteria for Adverse Events (CTCAE) neuropathy scale
Description
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.
Time Frame
Up to 14 days
Title
Incidence of adverse events
Description
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.
Time Frame
Up to 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacy D D'Andre
Organizational Affiliation
Mayo Clinic in Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Health System Albert Lea
City
Albert Lea
State/Province
Minnesota
ZIP/Postal Code
56007
Country
United States
Facility Name
Fairview Grand Itasca Clinic and Hospital
City
Grand Rapids
State/Province
Minnesota
ZIP/Postal Code
55744
Country
United States
Facility Name
Fairview Range Medical Center
City
Hibbing
State/Province
Minnesota
ZIP/Postal Code
55746
Country
United States
Facility Name
Mayo Clinic Health System Mankato
City
Mankato
State/Province
Minnesota
ZIP/Postal Code
56001
Country
United States
Facility Name
Monticello Cancer Center
City
Monticello
State/Province
Minnesota
ZIP/Postal Code
55362
Country
United States
Facility Name
Fairview Northland Medical Center
City
Princeton
State/Province
Minnesota
ZIP/Postal Code
55371
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Sanford Thief River Falls
City
Thief River Falls
State/Province
Minnesota
ZIP/Postal Code
56701
Country
United States
Facility Name
Sanford Worthington
City
Worthington
State/Province
Minnesota
ZIP/Postal Code
56187
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Topical Cannabidiol for the Treatment of Chemotherapy-Induced Peripheral Neuropathy

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