PEA for the Relief of Chemotherapy-Induced Peripheral Neuropathy

  • STATUS
    Recruiting
  • End date
    Jun 30, 2024
  • participants needed
    88
  • sponsor
    Academic and Community Cancer Research United
Updated on 4 July 2022
cancer

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.

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 (CIPN).

SECONDARY OBJECTIVES:

I. To assess the safety of PEA at the two study doses. II. To evaluate changes in patient-reported symptoms and quality of life from baseline to the end of 8 weeks.

OUTLINE: Patients are randomized to 1 of 4 arms.

ARM I: Patients receive PEA orally (PO) once daily (QD) for 8 weeks as long as there is not any unacceptable toxicity.

ARM II: Patients receive PEA PO twice daily (BID) for 8 weeks as long as there is not any unacceptable toxicity.

ARM III: Patients receive placebo PO QD for 8 weeks.

ARM IV: Patients receive placebo PO BID for 8 weeks.

After completion of study intervention, patients are followed up at 6 and 12 months.

Details
Condition Chemotherapy-Induced Peripheral Neuropathy, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Treatment quality-of-life assessment, Placebo Administration, Palmidrol, Palmidrol
Clinical Study IdentifierNCT05246670
SponsorAcademic and Community Cancer Research United
Last Modified on4 July 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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