Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-Induced Peripheral Neuropathy | — | UNRESOLVED | — |
| Hematopoietic and Lymphoid Cell Neoplasm | Hematopoietic and Lymphoid Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Malignant Solid Neoplasm | Malignant Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Palmidrol | Drug | — | UNRESOLVED |
| Placebo Administration | Drug | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- PLACEBO_COMPARATOR
- label
- BID placebo
- description
- Patients receive placebo PO BID for 8 weeks.
- interventionNames
- Drug: Placebo Administration
- Other: Quality-of-Life Assessment
- type
- EXPERIMENTAL
- label
- Higher-dose PEA
- description
- Patients receive PEA PO BID for 8 weeks as long as there is not any unacceptable toxicity.
- interventionNames
- Drug: Palmidrol
- Other: Quality-of-Life Assessment
- type
- EXPERIMENTAL
- label
- Lower-dose PEA
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
* Serum transaminase (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\]) =\< 1.2 x upper limit of normal (ULN)
* NOTE: Patients with a history of metastatic breast cancer or an ECOG performance status of 2 must have these labs completed =\< 28 days prior to registration
* Alkaline phosphatase =\< 1.2 x ULN
* 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
* Serum creatinine =\< 1.2 x ULN
* NOTE: Patients with a history of metastatic cancer or an ECOG performance status of 2 must have this lab completed =\< 28 days prior to registration
* Able to swallow oral medication
* Provide written informed consent =\< 28 days prior to registration
Exclusion Criteria:
* Currently receiving neurotoxic chemotherapy for a second cancer or recurrence of the primary cancer
* Impaired decision-making capacity (such as with a diagnosis of dementia or memory loss)
* Evidence of residual cancer, per routine clinical practice-based parameters
* Comorbid conditions:
* Previous diagnosis of diabetic or another non chemotherapy induced peripheral neuropathy
* Previous history of peripheral neuropathy prior to receiving neurotoxic chemotherapy
* Neuropathy from human immunodeficiency virus (HIV) infection. Note: Patients with HIV infections are eligible as long as they do not have a neuropathy from their viral illness
* Concurrent use of a cannabis product (tetrahydrocannabinol \[THC\] and/or cannabidiol \[CBD\]). Patients should have discontinued these products \>= 4 weeks prior to registration
* Current or previous use of PEA
* Currently receiving or planning to start any of the following agents: opioids, duloxetine, gabapentin or pregabalin. Patients are eligible if they discontinue these medications \>= 1 week prior to registration
* Any of the following because the study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown:
* Pregnant persons
* Nursing persons
* Persons of childbearing potential who are unwilling to employ adequate contraceptionReferences
Publications (0)
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