Ignite Creation Date:
2024-05-06 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05246670
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-30
First Post:
2022-02-11
Brief Title:
PEA for the Relief of Chemotherapy-Induced Peripheral Neuropathy
Sponsor:
Academic and Community Cancer Research United
Organization:
Academic and Community Cancer Research United
Study Overview
Official Title:
Treatment of Established Chemotherapy-Induced Neuropathy With N-Palmitoylethanolamide a Cannabimimetic Nutraceutical A Randomized Double-Blind Phase II Pilot Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-10
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 phase II trial tests whether PEA works to relieve the symptoms of chemotherapy-induced peripheral neuropathy in patients with cancer Chemotherapy-induced peripheral neuropathy refers to a nerve problem that causes pain numbness tingling or muscle weakness in different parts of the body and is caused by chemotherapy PEA may be useful against bothersome nerve symptoms
Detailed Description:
PRIMARY OBJECTIVE
I To look for evidence of the efficacy of PEA N-palmitoylethanolamide at two different doses relative to placebo responses as a treatment for chemotherapy-induced neuropathy CIPN
SECONDARY OBJECTIVES
I To assess the safety of PEA at the two study doses II To evaluate changes in patient-reported quality of life from baseline to the end of 8 weeks
EXPLORATORY OBJECTIVES
I To explore whether PEA appears to affect cognition in the study patients II To explore the weekly trajectory of CIPN from baseline to 8 weeks III To explore the weekly trajectory of pain using the single-item numerical rating scale from baseline to 8 weeks
IV To explore the weekly patient global impression of change in each treatment arm from baseline to 8 weeks
V To explore the weekly chemotherapy induced peripheral neuropathy in each treatment arm from baseline to 8 weeks
VI To explore the PEA effects on CIPN20 between two PEA dosage arms VII To explore the number of recurrent cancer events by study arm VIII To explore the overall survival by study arm
OUTLINE Patients are randomized to 1 of 4 arms
ARM I Patients receive PEA orally PO once daily QD for 8 weeks as long as there is not any unacceptable toxicity
ARM II Patients receive PEA PO twice daily BID for 8 weeks as long as there is not any unacceptable toxicity
ARM III Patients receive placebo PO QD for 8 weeks
ARM IV Patients receive placebo PO BID for 8 weeks
After completion of study intervention patients are followed up at 6 and 12 months
I To look for evidence of the efficacy of PEA N-palmitoylethanolamide at two different doses relative to placebo responses as a treatment for chemotherapy-induced neuropathy CIPN
SECONDARY OBJECTIVES
I To assess the safety of PEA at the two study doses II To evaluate changes in patient-reported quality of life from baseline to the end of 8 weeks
EXPLORATORY OBJECTIVES
I To explore whether PEA appears to affect cognition in the study patients II To explore the weekly trajectory of CIPN from baseline to 8 weeks III To explore the weekly trajectory of pain using the single-item numerical rating scale from baseline to 8 weeks
IV To explore the weekly patient global impression of change in each treatment arm from baseline to 8 weeks
V To explore the weekly chemotherapy induced peripheral neuropathy in each treatment arm from baseline to 8 weeks
VI To explore the PEA effects on CIPN20 between two PEA dosage arms VII To explore the number of recurrent cancer events by study arm VIII To explore the overall survival by study arm
OUTLINE Patients are randomized to 1 of 4 arms
ARM I Patients receive PEA orally PO once daily QD for 8 weeks as long as there is not any unacceptable toxicity
ARM II Patients receive PEA PO twice daily BID for 8 weeks as long as there is not any unacceptable toxicity
ARM III Patients receive placebo PO QD for 8 weeks
ARM IV Patients receive placebo PO BID for 8 weeks
After completion of study intervention patients are followed up at 6 and 12 months
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA015083 | NIH | Academic and Community Cancer Research United | httpsreporternihgovquickSearchP30CA015083 |
| NCI-2022-00002 | REGISTRY | None | None |
| ACCRU-SC-2102 | OTHER | None | None |