INTERVENTIONALACTIVE NOT RECRUITINGNCT05246670

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

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.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2025-09-22

What this record can show

Registry results are available

Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE2
Enrollment: 88 (ACTUAL)
Start date: 2022-05-16
Sponsor: Academic and Community Cancer Research United
Design: RANDOMIZED · PARALLEL · SUPPORTIVE CARE
Locations: 10
Results record: Present in registry snapshot

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.

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

No published condition report matched.

Cannabinoids and active compounds

palmitoyl ethanolamide

Medicines

No exact medicine-name link was found.

Interventions

What was registered

DRUG

Palmidrol

Given PEA PO

N-Palmitoyl Ethanolamide · N-Palmitoylethanolamide · OptiPEA · Palmitoyl Ethanolamide · Palmitoylethanolamide · PEA

DRUG

Placebo Administration

Given PO

OTHER

Quality-of-Life Assessment

Ancillary studies

Quality of Life Assessment

Source-reported results

Results posted to the registry

11 outcomes

Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.

Primary outcomes: 1
Secondary outcomes: 2
Statistical analyses: 3
Adverse-event terms: 29

PRIMARYMean Change in Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20) Score

Time frame: 8 weeks
Measure: MEAN · units on a scale
Reporting status: POSTED

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.

Population: All evaluable participants were included in analysis

Group	N	Value	Spread / interval
Lower-dose PEA	27	-4.2	5.42
Higher-dose PEA	30	-6.3	12.24
Combined Placebo	28	-6.4	7.50

Statistical analyses

Lower-dose PEA vs Combined PlaceboMethod not reportedMean Difference (Final Values): 2.21

Eligibility

Population and criteria

Sex: ALL
Minimum age: 18 Years
Maximum age: Not reported
Healthy volunteers: Not accepted

Inclusion criteria

Age \>= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2
NOTE: Patients with a history of metastatic cancer or an ECOG performance status of 2 must have laboratory (lab) work completed =\< 28 days prior to registration
Pain, numbness, tingling or other symptoms of CIPN of \>= 3 months (90 days) duration for which the patient is seeking an intervention
Neurotoxic chemotherapy must have been completed \>= 3 months (90 days) prior to registration and there must be no further planned neurotoxic -chemotherapy for \> 2 months after registration Note: The study is limited to those with taxane- and/or platinum-based neuropathy
Patient must note tingling, numbness or pain symptoms of at least a four out of ten =\< 7 days prior to registration.
Note: On a 0-10 scale where zero was 'no problem' and ten being 'as bad a problem that could be imagined': how much of a problem has numbness, tingling, and/or pain in your fingers and/or toes been in the past week?
Patient must be able to speak, read and comprehend English
For women of childbearing potential only, a negative urine or serum pregnancy test done =\< 14 days prior to registration is required
A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
NOTE: If the urine test cannot be confirmed as negative, a serum pregnancy test will be required
Life expectancy \>= 6 months
Platelet count \> 100,000/mm\^3
NOTE: Patients with a history of metastatic breast cancer or an ECOG performance status of 2 must have this lab completed =\< 28 days prior to registration
Absolute neutrophil count (ANC) \>= 1,000/mm\^3
NOTE: Patients with a history of metastatic breast cancer or an ECOG performance status of 2 must have this lab completed =\< 28 days prior to registration
Hemoglobin \> 11 g/dL
NOTE: Patients with a history of metastatic breast cancer or an ECOG performance status of 2 must have this lab completed =\< 28 days prior to registration

primary outcomes

primary measures

Mean Change in Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20) Score

Time frame: 8 weeks

secondary outcomes

secondary measures

Number of Participants Experiencing Grade 3+ Adverse Events

Time frame: 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).

Mean Change of Quality of Life

Time frame: 8 weeks

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.

other outcomes