PEA for the Relief of Chemotherapy-Induced Peripheral Neuropathy (NCT05246670) | Clinical Trial Compass
Active — Not RecruitingPhase 2
PEA for the Relief of Chemotherapy-Induced Peripheral Neuropathy
United States88 participantsStarted 2022-05-16
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 con…
What they're measuring
1
Mean Change in Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20) Score
Timeframe: 8 weeks
Trial details
NCT IDNCT05246670
SponsorAcademic and Community Cancer Research United