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

Who is this study for? Patients with Chemotherapy-Induced Peripheral Neuropathy
What treatments are being studied? Quality-of-Life Assessment
Status: Active_not_recruiting
Location: See all (10) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Connecticut
Middlesex Hospital
Middletown
Iowa
Siouxland Regional Cancer Center
Sioux City
Illinois
Carle Cancer Center NCI Community Oncology Research Program
Urbana
Minnesota
Mayo Clinic
Rochester
North Carolina
Cone Health Cancer Center
Greensboro
Pennsylvania
Geisinger Medical Center
Danville
South Dakota
Rapid City Regional Hospital
Rapid City
Tennessee
Vanderbilt University/Ingram Cancer Center
Nashville
Wisconsin
Mayo Clinic Health System Eau Claire Hospital-Luther Campus
Eau Claire
Mayo Clinic Health System-Franciscan Healthcare
La Crosse
Time Frame
Start Date: 2022-05-16
Completion Date: 2025-02-28
Participants
Target number of participants: 88
Treatments
Placebo_comparator: BID placebo
Patients receive placebo PO BID for 8 weeks.
Experimental: Higher-dose PEA
Patients receive PEA PO BID for 8 weeks as long as there is not any unacceptable toxicity.
Experimental: Lower-dose PEA
Patients receive PEA PO QD for 8 weeks as long as there is not any unacceptable toxicity.
Placebo_comparator: QD placebo
Patients receive placebo PO QD for 8 weeks.
Related Therapeutic Areas
Sponsors
Leads: Academic and Community Cancer Research United
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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