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Can a natural supplement soothe chemo nerve damage?

NCT ID NCT05246670

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

88 people

The number who actually took part.

Started

May 2022

Expected to finish

Feb 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Carle Cancer Center NCI Community Oncology Research Program

    Urbana, Illinois, 61801, United States

  • Cone Health Cancer Center

    Greensboro, North Carolina, 27403, United States

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic Health System Eau Claire Hospital-Luther Campus

    Eau Claire, Wisconsin, 54703, United States

  • Mayo Clinic Health System-Franciscan Healthcare

    La Crosse, Wisconsin, 54601, United States

  • Middlesex Hospital

    Middletown, Connecticut, 06457, United States

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701, United States

  • Siouxland Regional Cancer Center

    Sioux City, Iowa, 51101, United States

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232, United States

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Other studies related to the condition(s) this trial covers.