PEA for the Relief of Chemotherapy-Induced Peripheral Neuropathy

Overview

About this study

The purpose of this study the efectiveness of PEA (N-palmitoylethanolamide) at two different doses relative to placebo responses, as a treatment for chemotherapy-induced neuropathy (CIPN). Also, to assess the safety of PEA at the two study doses, and to evaluate changes in patient-reported symptoms and quality of life from baseline to the end of 8 weeks.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- 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 Criteria:

- 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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/30/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Charles Loprinzi, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Eau Claire, Wis.

Mayo Clinic principal investigator

Eyad Al-Hattab, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions