Chemotherapy-Induced Peripheral NeuropathyPhase 2NCT05246670
PEA for the Relief of Chemotherapy-Induced Peripheral Neuropathy
A Phase 2 study testing Palmidrol and Quality-of-Life Assessment in people with Chemotherapy-Induced Peripheral Neuropathy and Hematopoietic and Lymphoid Cell Neoplasm, run by Academic and Community Cancer Research United at 10 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-Induced Peripheral Neuropathy, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Palmidrol and Quality-of-Life Assessment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 10 sitesUnited States
- Study dates
- 16 May 2022to 28 Feb 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Geisinger Medical Center
Danville, Pennsylvania, 17822
Mayo Clinic Health System Eau Claire Hospital-Luther Campus
Eau Claire, Wisconsin, 54703
Cone Health Cancer Center
Greensboro, North Carolina, 27403
Mayo Clinic Health System-Franciscan Healthcare
La Crosse, Wisconsin, 54601
Middlesex Hospital
Middletown, Connecticut, 06457
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Rapid City Regional Hospital
Rapid City, South Dakota, 57701
Mayo Clinic
Rochester, Minnesota, 55905
Siouxland Regional Cancer Center
Sioux City, Iowa, 51101
Carle Cancer Center NCI Community Oncology Research Program
Urbana, Illinois, 61801
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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.
- 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.
- Conditions
- Chemotherapy-Induced Peripheral Neuropathy, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- Being tested
- Palmidrol, Placebo Administration, Quality-of-Life Assessment
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalmidrolDrug
Also called N-Palmitoyl Ethanolamide, N-Palmitoylethanolamide, OptiPEA, Palmitoyl Ethanolamide
Given PEA PO
Placebo AdministrationDrug
Given PO
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| BID placebo | Placebo comparator | Patients receive placebo PO BID for 8 weeks. Receives: Drug: Placebo Administration; Other: Quality-of-Life Assessment |
| Higher-dose PEA | Experimental | Patients receive PEA PO BID for 8 weeks as long as there is not any unacceptable toxicity. Receives: Drug: Palmidrol; Other: Quality-of-Life Assessment |
| Lower-dose PEA | Experimental | Patients receive PEA PO QD for 8 weeks as long as there is not any unacceptable toxicity. Receives: Drug: Palmidrol; Other: Quality-of-Life Assessment |
| QD placebo | Placebo comparator | Patients receive placebo PO QD for 8 weeks. Receives: Drug: Placebo Administration; Other: Quality-of-Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20) Score
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.
Measured: 8 weeks
Secondary outcomes (2)
Number of Participants Experiencing Grade 3+ Adverse Events
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).
Measured: 8 weeks
Mean Change of Quality of Life
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start16 May 2022
- Primary completion12 Feb 2024
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chemotherapy-Induced Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academic and Community Cancer Research United
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mellar P Davis, Principal investigator, Academic and Community Cancer Research United
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246670
- Sponsor's protocol ID
- ACCRU-SC-2102
- Other IDs
- NCI-2022-00002, ACCRU-SC-2102, P30CA015083
- Status last verified
- Sep 2025
- First submitted
- 11 Feb 2022
- Last updated
- 22 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Established Chemotherapy-Induced Neuropathy With N-Palmitoylethanolamide, a Cannabimimetic Nutraceutical: A Randomized Double-Blind Phase II Pilot Trial
- ClinicalTrials.gov ID
- NCT05246670
- Acronym / sponsor ID
- ACCRU-SC-2102
- Conditions
- Chemotherapy-Induced Peripheral Neuropathy, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Academic and Community Cancer Research UnitedUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 May 2022 (actual)
- Primary completion
- 12 Feb 2024 (actual)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 18 Feb 2022 (actual)
- Results
- Posted 24 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BID placebo | Placebo comparator | Drug: Placebo Administration, Other: Quality-of-Life AssessmentPatients receive placebo PO BID for 8 weeks. |
| Higher-dose PEA | Experimental | Drug: Palmidrol, Other: Quality-of-Life AssessmentPatients receive PEA PO BID for 8 weeks as long as there is not any unacceptable toxicity. |
| Lower-dose PEA | Experimental | Drug: Palmidrol, Other: Quality-of-Life AssessmentPatients receive PEA PO QD for 8 weeks as long as there is not any unacceptable toxicity. |
| QD placebo | Placebo comparator | Drug: Placebo Administration, Other: Quality-of-Life AssessmentPatients receive placebo PO QD for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Age >= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2
- 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.
Key exclusion criteria (14 listed)
- 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:
- Concurrent use of a cannabis product (tetrahydrocannabinol [THC] and/or cannabidiol [CBD]). Patients should have discontinued these products >= 4 weeks prior to registration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PalmidrolAlso: N-Palmitoyl Ethanolamide, N-Palmitoylethanolamide, OptiPEA, Palmitoyl EthanolamideGiven PEA PO | Drug | Higher-dose PEA, Lower-dose PEA |
| Placebo AdministrationGiven PO | Drug | BID placebo, QD placebo |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | BID placebo, Higher-dose PEA, Lower-dose PEA, QD placebo |
Primary outcome
Mean Change in Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20) Score
Time frame: 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 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.
2 secondary outcomes
Number of Participants Experiencing Grade 3+ Adverse Events
Time frame: 8 weeks
Mean Change of Quality of Life
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Continuous Controlled Cooling for Prevention of Chemotherapy-Induced Peripheral Neuropathy
Chemotherapy Induced Peripheral Neuropathy (CIPN)
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy
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The Effect of Aerobic and Resistance Training With and Without Neurodynamic Exercises on Chemotherapy-induced Peripheral Neuropathy Symptoms and Associated Neuro-immune Mechanisms
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Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients, Metastatic Colorectal Cancer (CRC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mellar P Davis principal investigator
Academic and Community Cancer Research United
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Palmidrol and Quality-of-Life Assessment in people with Chemotherapy-Induced Peripheral Neuropathy and Hematopoietic and Lymphoid Cell Neoplasm, run by Academic and Community Cancer Research United at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20) Score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.