Trial Outcomes & Findings for PEA for the Relief of Chemotherapy-Induced Peripheral Neuropathy (NCT NCT05246670)

Last Updated: 2025-09-22

Results Overview

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, 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. The CIPN20 includes 20 items, each asking a participant to rate their experience with certain symptoms from 1 to 4, with 1 being no difficulty with the symptom and 4 being the most difficulty with the symptom. Answers are then summed to give a total score from 20 to 80.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

88 participants

Primary outcome timeframe

8 weeks

Results posted on

2025-09-22

Participant Flow

Participant milestones

Participant milestones
Measure	Lower-dose PEA Patients receive PEA PO QD for 8 weeks as long as there is not any unacceptable toxicity.\> \> Palmidrol: Given PEA PO\> \> Quality-of-Life Assessment: Ancillary studies	Higher-dose PEA Patients receive PEA PO BID for 8 weeks as long as there is not any unacceptable toxicity.\> \> Palmidrol: Given PEA PO\> \> Quality-of-Life Assessment: Ancillary studies	QD Placebo Patients receive placebo PO QD for 8 weeks.\> \> Placebo Administration: Given PO\> \> Quality-of-Life Assessment: Ancillary studies	BID Placebo Patients receive placebo PO BID for 8 weeks.\> \> Placebo Administration: Given PO\> \> Quality-of-Life Assessment: Ancillary studies
Overall Study STARTED	29	30	14	15
Overall Study COMPLETED	25	27	13	14
Overall Study NOT COMPLETED	4	3	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Lower-dose PEA Patients receive PEA PO QD for 8 weeks as long as there is not any unacceptable toxicity.\> \> Palmidrol: Given PEA PO\> \> Quality-of-Life Assessment: Ancillary studies	Higher-dose PEA Patients receive PEA PO BID for 8 weeks as long as there is not any unacceptable toxicity.\> \> Palmidrol: Given PEA PO\> \> Quality-of-Life Assessment: Ancillary studies	QD Placebo Patients receive placebo PO QD for 8 weeks.\> \> Placebo Administration: Given PO\> \> Quality-of-Life Assessment: Ancillary studies	BID Placebo Patients receive placebo PO BID for 8 weeks.\> \> Placebo Administration: Given PO\> \> Quality-of-Life Assessment: Ancillary studies
Overall Study Withdrawal by Subject	2	3	0	1
Overall Study Adverse Event	0	0	1	0
Overall Study Physician Decision	1	0	0	0
Overall Study Protocol Violation	1	0	0	0

Baseline Characteristics

PEA for the Relief of Chemotherapy-Induced Peripheral Neuropathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lower-dose PEA n=29 Participants Patients receive PEA PO QD for 8 weeks as long as there is not any unacceptable toxicity.\> \> Palmidrol: Given PEA PO\> \> Quality-of-Life Assessment: Ancillary studies	Higher-dose PEA n=30 Participants Patients receive PEA PO BID for 8 weeks as long as there is not any unacceptable toxicity.\> \> Palmidrol: Given PEA PO\> \> Quality-of-Life Assessment: Ancillary studies	QD Placebo n=14 Participants Patients receive placebo PO QD for 8 weeks.\> \> Placebo Administration: Given PO\> \> Quality-of-Life Assessment: Ancillary studies	BID Placebo n=15 Participants Patients receive placebo PO BID for 8 weeks.\> \> Placebo Administration: Given PO\> \> Quality-of-Life Assessment: Ancillary studies	Total n=88 Participants Total of all reporting groups
Age, Continuous	66 years STANDARD_DEVIATION 7.96 • n=5 Participants	60 years STANDARD_DEVIATION 10.11 • n=7 Participants	56.9 years STANDARD_DEVIATION 8.47 • n=5 Participants	67.3 years STANDARD_DEVIATION 6.05 • n=4 Participants	62.7 years STANDARD_DEVIATION 9.30 • n=21 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	24 Participants n=7 Participants	11 Participants n=5 Participants	12 Participants n=4 Participants	71 Participants n=21 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	17 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants	27 Participants n=7 Participants	12 Participants n=5 Participants	15 Participants n=4 Participants	81 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	13 Participants n=21 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	25 Participants n=7 Participants	12 Participants n=5 Participants	13 Participants n=4 Participants	72 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Region of Enrollment United States	29 participants n=5 Participants	30 participants n=7 Participants	14 participants n=5 Participants	15 participants n=4 Participants	88 participants n=21 Participants
Prior Chemotherapy Any Taxane +/- carboplatin +/- other agents	21 Participants n=5 Participants	21 Participants n=7 Participants	10 Participants n=5 Participants	11 Participants n=4 Participants	63 Participants n=21 Participants
Prior Chemotherapy Oxaliplatin based	8 Participants n=5 Participants	8 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	24 Participants n=21 Participants
Prior Chemotherapy Other (never received a taxane nor oxaliplatin)	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
BMI	32.1 kg/m^2 STANDARD_DEVIATION 8.62 • n=5 Participants	31.3 kg/m^2 STANDARD_DEVIATION 6.81 • n=7 Participants	35.1 kg/m^2 STANDARD_DEVIATION 8.74 • n=5 Participants	31.0 kg/m^2 STANDARD_DEVIATION 7.78 • n=4 Participants	32.1 kg/m^2 STANDARD_DEVIATION 7.90 • n=21 Participants
ECOG Performance Status 0	14 Participants n=5 Participants	14 Participants n=7 Participants	8 Participants n=5 Participants	7 Participants n=4 Participants	43 Participants n=21 Participants
ECOG Performance Status 1+	15 Participants n=5 Participants	16 Participants n=7 Participants	6 Participants n=5 Participants	8 Participants n=4 Participants	45 Participants n=21 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: All evaluable participants were included in analysis

Outcome measures

Outcome measures
Measure	Lower-dose PEA n=27 Participants Patients receive PEA PO QD for 8 weeks as long as there is not any unacceptable toxicity. \> \> Palmidrol: Given PEA PO \> \> Quality-of-Life Assessment: Ancillary studies	Higher-dose PEA n=30 Participants Patients receive PEA PO BID for 8 weeks as long as there is not any unacceptable toxicity. \> \> Palmidrol: Given PEA PO \> \> Quality-of-Life Assessment: Ancillary studies	Combined Placebo n=28 Participants Patients receive placebo PO QD or BID for 8 weeks. \> \> Placebo Administration: Given PO \> \> Quality-of-Life Assessment: Ancillary studies
Mean Change in Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20) Score	-4.2 units on a scale Standard Deviation 5.42	-6.3 units on a scale Standard Deviation 12.24	-6.4 units on a scale Standard Deviation 7.50

SECONDARY outcome

Timeframe: 8 weeks

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).

Outcome measures

Outcome measures
Measure	Lower-dose PEA n=29 Participants Patients receive PEA PO QD for 8 weeks as long as there is not any unacceptable toxicity. \> \> Palmidrol: Given PEA PO \> \> Quality-of-Life Assessment: Ancillary studies	Higher-dose PEA n=30 Participants Patients receive PEA PO BID for 8 weeks as long as there is not any unacceptable toxicity. \> \> Palmidrol: Given PEA PO \> \> Quality-of-Life Assessment: Ancillary studies	Combined Placebo n=29 Participants Patients receive placebo PO QD or BID for 8 weeks. \> \> Placebo Administration: Given PO \> \> Quality-of-Life Assessment: Ancillary studies
Number of Participants Experiencing Grade 3+ Adverse Events	2 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: All evaluable participants were included in analysis

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. Question 3 of the PRO-QOL is a 10 point scale asking participants to rate their quality of life, with 0 being the worst and 10 being the best.

Outcome measures

Outcome measures
Measure	Lower-dose PEA n=27 Participants Patients receive PEA PO QD for 8 weeks as long as there is not any unacceptable toxicity. \> \> Palmidrol: Given PEA PO \> \> Quality-of-Life Assessment: Ancillary studies	Higher-dose PEA n=30 Participants Patients receive PEA PO BID for 8 weeks as long as there is not any unacceptable toxicity. \> \> Palmidrol: Given PEA PO \> \> Quality-of-Life Assessment: Ancillary studies	Combined Placebo n=28 Participants Patients receive placebo PO QD or BID for 8 weeks. \> \> Placebo Administration: Given PO \> \> Quality-of-Life Assessment: Ancillary studies
Mean Change of Quality of Life	0.6 units on a scale Standard Deviation 2.71	0.6 units on a scale Standard Deviation 2.73	-0.6 units on a scale Standard Deviation 1.91

Adverse Events

Lower-dose PEA

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Higher-dose PEA

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

QD Placebo

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

BID Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lower-dose PEA n=29 participants at risk Quality-of-Life Assessment: Ancillary studies	Higher-dose PEA n=30 participants at risk Quality-of-Life Assessment: Ancillary studies	QD Placebo n=14 participants at risk Quality-of-Life Assessment: Ancillary studies	BID Placebo n=15 participants at risk Quality-of-Life Assessment: Ancillary studies
Nervous system disorders Dizziness	3.4% 1/29 • Number of events 1 • 2 months	0.00% 0/30 • 2 months	0.00% 0/14 • 2 months	0.00% 0/15 • 2 months
Infections and infestations Infections and infestations - Other, specify	3.4% 1/29 • Number of events 1 • 2 months	0.00% 0/30 • 2 months	0.00% 0/14 • 2 months	0.00% 0/15 • 2 months
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.00% 0/29 • 2 months	0.00% 0/30 • 2 months	7.1% 1/14 • Number of events 1 • 2 months	0.00% 0/15 • 2 months
Vascular disorders Superior vena cava syndrome	0.00% 0/29 • 2 months	0.00% 0/30 • 2 months	7.1% 1/14 • Number of events 1 • 2 months	0.00% 0/15 • 2 months

Other adverse events

Other adverse events
Measure	Lower-dose PEA n=29 participants at risk Quality-of-Life Assessment: Ancillary studies	Higher-dose PEA n=30 participants at risk Quality-of-Life Assessment: Ancillary studies	QD Placebo n=14 participants at risk Quality-of-Life Assessment: Ancillary studies	BID Placebo n=15 participants at risk Quality-of-Life Assessment: Ancillary studies
Metabolism and nutrition disorders Anorexia	3.4% 1/29 • Number of events 1 • 2 months	0.00% 0/30 • 2 months	0.00% 0/14 • 2 months	0.00% 0/15 • 2 months
Psychiatric disorders Anxiety	0.00% 0/29 • 2 months	0.00% 0/30 • 2 months	0.00% 0/14 • 2 months	6.7% 1/15 • Number of events 1 • 2 months
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/29 • 2 months	3.3% 1/30 • Number of events 1 • 2 months	0.00% 0/14 • 2 months	0.00% 0/15 • 2 months
Gastrointestinal disorders Constipation	3.4% 1/29 • Number of events 1 • 2 months	0.00% 0/30 • 2 months	0.00% 0/14 • 2 months	0.00% 0/15 • 2 months
Psychiatric disorders Depression	3.4% 1/29 • Number of events 1 • 2 months	0.00% 0/30 • 2 months	0.00% 0/14 • 2 months	0.00% 0/15 • 2 months
Gastrointestinal disorders Diarrhea	13.8% 4/29 • Number of events 5 • 2 months	0.00% 0/30 • 2 months	7.1% 1/14 • Number of events 1 • 2 months	0.00% 0/15 • 2 months
Nervous system disorders Dizziness	3.4% 1/29 • Number of events 1 • 2 months	0.00% 0/30 • 2 months	7.1% 1/14 • Number of events 1 • 2 months	6.7% 1/15 • Number of events 1 • 2 months
Gastrointestinal disorders Dry mouth	0.00% 0/29 • 2 months	0.00% 0/30 • 2 months	7.1% 1/14 • Number of events 1 • 2 months	0.00% 0/15 • 2 months
Skin and subcutaneous tissue disorders Eczema	0.00% 0/29 • 2 months	0.00% 0/30 • 2 months	7.1% 1/14 • Number of events 1 • 2 months	0.00% 0/15 • 2 months
Injury, poisoning and procedural complications Fall	3.4% 1/29 • Number of events 1 • 2 months	0.00% 0/30 • 2 months	0.00% 0/14 • 2 months	0.00% 0/15 • 2 months
General disorders Fatigue	6.9% 2/29 • Number of events 3 • 2 months	0.00% 0/30 • 2 months	0.00% 0/14 • 2 months	0.00% 0/15 • 2 months
Nervous system disorders Headache	3.4% 1/29 • Number of events 1 • 2 months	3.3% 1/30 • Number of events 1 • 2 months	0.00% 0/14 • 2 months	0.00% 0/15 • 2 months
Vascular disorders Hot flashes	3.4% 1/29 • Number of events 1 • 2 months	0.00% 0/30 • 2 months	0.00% 0/14 • 2 months	0.00% 0/15 • 2 months
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/29 • 2 months	3.3% 1/30 • Number of events 1 • 2 months	0.00% 0/14 • 2 months	0.00% 0/15 • 2 months
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/29 • 2 months	0.00% 0/30 • 2 months	0.00% 0/14 • 2 months	6.7% 1/15 • Number of events 1 • 2 months
Metabolism and nutrition disorders Hypokalemia	0.00% 0/29 • 2 months	0.00% 0/30 • 2 months	0.00% 0/14 • 2 months	6.7% 1/15 • Number of events 1 • 2 months
Infections and infestations Infections and infestations - Other, specify	3.4% 1/29 • Number of events 1 • 2 months	0.00% 0/30 • 2 months	7.1% 1/14 • Number of events 1 • 2 months	6.7% 1/15 • Number of events 1 • 2 months
Nervous system disorders Lethargy	0.00% 0/29 • 2 months	0.00% 0/30 • 2 months	7.1% 1/14 • Number of events 1 • 2 months	0.00% 0/15 • 2 months
Musculoskeletal and connective tissue disorders Muscle cramp	3.4% 1/29 • Number of events 2 • 2 months	0.00% 0/30 • 2 months	0.00% 0/14 • 2 months	0.00% 0/15 • 2 months
Gastrointestinal disorders Nausea	3.4% 1/29 • Number of events 2 • 2 months	10.0% 3/30 • Number of events 3 • 2 months	7.1% 1/14 • Number of events 1 • 2 months	13.3% 2/15 • Number of events 2 • 2 months
General disorders Non-cardiac chest pain	0.00% 0/29 • 2 months	0.00% 0/30 • 2 months	0.00% 0/14 • 2 months	6.7% 1/15 • Number of events 1 • 2 months
Cardiac disorders Palpitations	3.4% 1/29 • Number of events 1 • 2 months	0.00% 0/30 • 2 months	0.00% 0/14 • 2 months	0.00% 0/15 • 2 months
Nervous system disorders Peripheral sensory neuropathy	3.4% 1/29 • Number of events 1 • 2 months	0.00% 0/30 • 2 months	0.00% 0/14 • 2 months	0.00% 0/15 • 2 months
Skin and subcutaneous tissue disorders Rash maculo-papular	3.4% 1/29 • Number of events 1 • 2 months	0.00% 0/30 • 2 months	7.1% 1/14 • Number of events 1 • 2 months	0.00% 0/15 • 2 months
Gastrointestinal disorders Vomiting	0.00% 0/29 • 2 months	3.3% 1/30 • Number of events 1 • 2 months	7.1% 1/14 • Number of events 1 • 2 months	6.7% 1/15 • Number of events 1 • 2 months

Additional Information

Mellar P. Davis, MD, FCCP, FAAHPM

Geisinger Medical Center

Phone: 570-271-7383

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place