Ignite Creation Date:
2024-05-06 @ 5:39 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05388058
Status:
COMPLETED
Last Update Posted:
2024-04-26
First Post:
2022-05-19
Brief Title:
Topical Cannabidiol for the Treatment of Chemotherapy-Induced Peripheral Neuropathy
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Topical Cannabidiol CBD for the Treatment of Chemotherapy-Induced Peripheral Neuropathy A Randomized Placebo-Controlled Pilot Trial
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 v50
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
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 v50
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 21-011969 | OTHER | Mayo Clinic Institutional Review Board | None |
| NCI-2022-02479 | REGISTRY | None | None |