Can a natural supplement soothe chemo nerve damage?
NCT ID NCT05246670
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This phase II trial tests whether a natural supplement called PEA can relieve nerve pain, numbness, and tingling caused by chemotherapy in cancer patients. About 88 adults who have had nerve symptoms for at least 3 months after chemo will take PEA or a placebo for 8 weeks. The study measures changes in symptom severity using a standard questionnaire.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PEA (Palmitoylethanolamide), a natural supplement
- What this could lead to
- If it works, this could point toward a safe, non-drug option to relieve nerve pain and numbness from chemotherapy.
- What could go wrong
- This is a small, early-phase pilot trial with only 88 participants. The supplement may not work better than a placebo, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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88 people
The number who actually took part.
- Started
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May 2022
- Expected to finish
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Feb 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 contraception
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Carle Cancer Center NCI Community Oncology Research Program
Urbana, Illinois, 61801, United States
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Cone Health Cancer Center
Greensboro, North Carolina, 27403, United States
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Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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Mayo Clinic Health System Eau Claire Hospital-Luther Campus
Eau Claire, Wisconsin, 54703, United States
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Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601, United States
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Middlesex Hospital
Middletown, Connecticut, 06457, United States
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Rapid City Regional Hospital
Rapid City, South Dakota, 57701, United States
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Siouxland Regional Cancer Center
Sioux City, Iowa, 51101, United States
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Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
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Other studies related to the condition(s) this trial covers.
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