PEA for the Relief of Chemotherapy-Induced Peripheral Neuropathy
Active, enrolledPhase 2Results postedLast updated 22 September 2025
What this trial tests
Phase 2 trial testing Palmidrol in Chemotherapy-Induced Peripheral Neuropathy in 88 participants. Participants enrolled and being followed up; not accepting new ones.
18 and older, any sex, with Chemotherapy-Induced Peripheral Neuropathy or Hematopoietic and Lymphoid Cell Neoplasm. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean Change in Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20) ScorePrimary· 8 weeks
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
Group
Value
95% CI
Lower-dose PEA
-4.2
± 5.42
Higher-dose PEA
-6.3
± 12.24
Combined Placebo
-6.4
± 7.50
Number of Participants Experiencing Grade 3+ Adverse EventsSecondary· 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).
Group
Value
95% CI
Lower-dose PEA
2
Higher-dose PEA
0
Combined Placebo
2
Mean Change of Quality of LifeSecondary· 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 p
Group
Value
95% CI
Lower-dose PEA
0.6
± 2.71
Higher-dose PEA
0.6
± 2.73
Combined Placebo
-0.6
± 1.91
Adverse events — posted to ClinicalTrials.gov
Time frame: 2 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Academic and Community Cancer Research United
Last refreshed: 22 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05246670.