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Patients receive placebo PO BID for 8 weeks.

Patients receive PEA PO BID for 8 weeks as long as there is not any unacceptable toxicity.

Patients receive PEA PO QD for 8 weeks as long as there is not any unacceptable toxicity.

Patients receive placebo PO QD for 8 weeks.

Placebo Administration

Quality-of-Life Assessment

Mellar P Davis

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.

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.

PEA for the Relief of Chemotherapy-Induced Peripheral Neuropathy

Treatment of Established Chemotherapy-Induced Neuropathy With N-Palmitoylethanolamide, a Cannabimimetic Nutraceutical: A Randomized Double-Blind Phase II Pilot Trial

Will be summarized by mean (SD) and median (range) by treatment arm and the combined placebo arm. The difference in change score will be estimated along with the 95% confidence interval.

Will be summarized at each time point by mean (SD) and median (range) and will be plotted longitudinally by treatment arm and the combine placebo arm.

Will be summarized by frequency (percentage) of each level at each time point for each treatment arm and the combine placebo arm. Bar plots for each PEA arm and the combined placebo arm of frequency over time will be constructed.

Will be summarized by mean (SD) and median (range) at each time point for each treatment arm and the combine placebo arm.

Will be calculated for each patient. The mean and standard deviation of the change will be calculated for each PEA arm. The difference in CIPN20 change scores between the two PEA dosage arms will be estimated along with a 95% confidence interval.

The number of events and percentage will be reported by each PEA arm and combined placebo arm. No hypothesis test will be performed between arms.

For each PEA arm and combined placebo arm, the distributions of OS time will be estimated using the Kaplan-Meier method. Log-rank test will be used to compare the survival distributions between each PEA and the combined placebo arm.

Will be scored and summarized at each time point for each patient. The change from baseline to 8 weeks will then be calculated for each patient. The mean (standard deviation \[SD\]) and median (range) of the change will be calculated for each PEA arm and the combined placebo arm. The difference in change scores between each PEA arm and the combined placebo will be estimated along with a 95% confidence interval. For the primary analysis, the CIPN20 analysis dataset will include all eligible patients who are randomized, initiated treatment, and completed the baseline questionnaire. For patients who go off protocol treatment before 8 weeks, the score at their final observation will be used to calculate the change. For patients who do not have any post baseline data, they will be considered to have no change from baseline.

Adverse events by patient will be summarized by frequencies and severity using Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. The proportion of patients who experience at least one grade 3+ adverse event (regardless of attribution) will be reported. The overall adverse event rates for grade 3 or higher adverse events will be compared across the three arms (the two PEA arms and combined placebo) using a Chi-squared or Fisher's Exact tests as appropriate.

Will be assessed by Question 3, patient-reported outcomes-quality of life (PRO-QOL). The mean and standard deviation of the change will be reported for each PEA arm and the combined placebo arm. Additional analysis using data collected from the Symptom Experience Diary may be performed. For patients who go off protocol treatment before 8 weeks, the question 3 response at their final observation will be used to calculate the change. For patients who do not have any post baseline data, they will be considered to have no change from baseline.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
PEA for the Relief of Chemotherapy-Induced Peripheral Neuropathy	NCT05246670	Chemotherapy-In... Hematopoietic a... Malignant Solid...	Palmidrol Placebo Adminis... Quality-of-Life...	18 Years -	Academic and Community Cancer Research United
PEA for the Relief of Chemotherapy-Induced Peripheral Neuropathy	NCT05246670	Chemotherapy-In... Hematopoietic a... Malignant Solid...	Palmidrol Placebo Adminis... Quality-of-Life...	18 Years -	Academic and Community Cancer Research United

Spots Global Cancer Trial Database for palmidrol

Every month we try and update this database with for palmidrol cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for palmidrol

Every month we try and update this database with for palmidrol cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for palmidrol cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.