Treatment of Established Chemotherapy-Induced Neuropathy With N-Palmitoylethanolamide, a Cannabimimetic Nutraceutical: A Randomized Double-Blind Phase II Pilot Tria

• Status: Not yet recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

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 chemotherapy. PEA may be useful against bothersome nerve symptoms.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Academic and Community Cancer Research United
• Collaborator: National Cancer Institute (NCI)
• Treatments: Palmidrol

Criteria

Inclusion Criteria:

• Age >= 18 years

• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2

• NOTE: Patients with a history of metastatic breast 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 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 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 breast 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 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