Status:
ACTIVE_NOT_RECRUITING
PEA for the Relief of Chemotherapy-Induced Peripheral Neuropathy
Lead Sponsor:
Academic and Community Cancer Research United
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Chemotherapy-Induced Peripheral Neuropathy
Hematopoietic and Lymphoid Cell Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
PRIMARY OBJECTIVE: I. 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 (C...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2026
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT05246670
Start Date
May 16 2022
End Date
February 28 2026
Last Update
September 22 2025
Active Locations (10)
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1
Middlesex Hospital
Middletown, Connecticut, United States, 06457
2
Carle Cancer Center NCI Community Oncology Research Program
Urbana, Illinois, United States, 61801
3
Siouxland Regional Cancer Center
Sioux City, Iowa, United States, 51101
4
Mayo Clinic
Rochester, Minnesota, United States, 55905