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.
• 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