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PEA for Chemotherapy-Induced Peripheral Neuropathy
Phase 2
Waitlist Available
Led By Mellar P Davis
Research Sponsored by Academic and Community Cancer Research United
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 and 12 months
Awards & highlights
Study Summary
This trial is testing whether a drug called PEA can help relieve symptoms of chemotherapy-induced nerve damage. This nerve damage can cause pain, numbness, tingling, or muscle weakness, and PEA may help against these bothersome symptoms.
Who is the study for?
Adults with pain, numbness, or tingling from chemotherapy-induced peripheral neuropathy for at least 3 months can join this trial. They must have finished neurotoxic chemo at least 3 months ago and not plan to start any within the next 2 months. Participants need a stable blood count, be able to swallow pills, and women of childbearing age must test negative for pregnancy.Check my eligibility
What is being tested?
The trial is testing PEA's effectiveness in relieving nerve pain symptoms caused by chemotherapy. Patients will either receive PEA or a placebo (a substance with no active drug) while their quality of life is monitored to see if there's an improvement in their symptoms.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones associated with clinical trials may include digestive issues, headaches, dizziness, fatigue or allergic reactions. The study aims to determine if PEA causes any adverse effects when used for nerve pain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman capable of becoming pregnant.
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I can take care of myself but may not be able to do heavy physical work.
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I am 18 years old or older.
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I finished chemotherapy that affects nerves 3 months ago and have no plans for more within 2 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 6 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 (CIPN20) score
Secondary outcome measures
Difference in change of quality of life
Incidence of adverse events
Other outcome measures
CIPN20 score
Change in the two cognitive items of the Cognitive Functioning Assessment
Chemotherapy Induced Peripheral Neuropathy Assessment Tool
+5 moreSide effects data
From 2018 Phase 2 trial • 17 Patients • NCT03066193100%
Fatigue/Drowsiness
100%
Feeling "high"
94%
Dry Mouth
81%
Difficulty concentrating
81%
Dizziness/Lightneadedness
69%
Headache
69%
Weakness, unsteadiness
69%
Anxiety
63%
Warmth or tingly feeling
63%
Ataxia
63%
Gaps in memory
56%
Clumsiness
56%
Lack of coordination
56%
Depersonalization
50%
Increased apetite
50%
Nausea
44%
Red eyes
44%
Exagerated sense or well being
44%
Heavy limbs/muscles
38%
Paranoia
38%
Sleep problems (insomnia)
38%
Blurry vision
38%
Decrease in apetite
31%
Mood changes
31%
Muscle aches/pains
25%
Stomach pain
25%
Diarrhea
25%
Panic attack
13%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dronabinol and Palmitoylethanolamide
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Lower-dose PEAExperimental Treatment2 Interventions
Patients receive PEA PO QD for 8 weeks as long as there is not any unacceptable toxicity.
Group II: Higher-dose PEAExperimental Treatment2 Interventions
Patients receive PEA PO BID for 8 weeks as long as there is not any unacceptable toxicity.
Group III: QD placeboPlacebo Group2 Interventions
Patients receive placebo PO QD for 8 weeks.
Group IV: BID placeboPlacebo Group2 Interventions
Patients receive placebo PO BID for 8 weeks.
Find a Location
Who is running the clinical trial?
Academic and Community Cancer Research UnitedLead Sponsor
53 Previous Clinical Trials
5,048 Total Patients Enrolled
2 Trials studying Peripheral Neuropathy
93 Patients Enrolled for Peripheral Neuropathy
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,925,985 Total Patients Enrolled
14 Trials studying Peripheral Neuropathy
1,473 Patients Enrolled for Peripheral Neuropathy
Mellar P DavisPrincipal InvestigatorAcademic and Community Cancer Research United
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had recent lab work if I have metastatic breast cancer or am somewhat limited in physical activities.I stopped using cannabis products at least 4 weeks ago.The levels of certain liver enzymes in your blood are not higher than normal.I have felt tingling, numbness, or pain at a level of 4 out of 10 or more in the last week.Your kidney function, as measured by serum creatinine, needs to be within a certain range.I have signed the consent form within the last 28 days.I have nerve damage not caused by chemotherapy.I am a woman capable of becoming pregnant.Your alkaline phosphatase level is not more than 1.2 times the upper limit of normal.I am currently undergoing chemotherapy that affects my nerves for a second cancer or a recurrence.I can take care of myself but may not be able to do heavy physical work.Your white blood cell count is at least 1,000 per cubic millimeter.I am 18 years old or older.Your hemoglobin level is higher than 11 grams per deciliter.You are expected to live for at least 6 more months.I am a woman who can have children and have a recent negative pregnancy test.I have felt tingling, numbness, or pain at a level of 4 out of 10 or more in the last week.My numbness, tingling, or pain level is between 0 and 10.I have HIV but do not suffer from neuropathy caused by it.I have had pain or numbness for over 3 months due to nerve damage.I had nerve pain or tingling before starting chemotherapy that can affect nerves.I finished chemotherapy that affects the nerves more than 3 months ago and have no plans for similar treatment soon.I am currently using or planning to use pain medication soon.I can take pills by mouth.I have used PEA before.There are signs of cancer still present based on regular check-ups.I had recent lab work if I have a history of metastatic cancer or my physical ability is somewhat limited.I have difficulty making decisions due to memory loss or dementia.Your platelet count is higher than 100,000 per cubic millimeter.I finished chemotherapy that affects nerves 3 months ago and have no plans for more within 2 months.
Research Study Groups:
This trial has the following groups:- Group 1: Higher-dose PEA
- Group 2: Lower-dose PEA
- Group 3: QD placebo
- Group 4: BID placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the mortality rate of Palmidrol?
"There is some evidence that Palmidrol is safe, but none yet to support its efficacy. It received a score of 2."
Answered by AI
Are new patients being enrolled in this study?
"That is correct. According to the listing on clinicaltrials.gov, this trial has 88 open positions for patients at 10 different locations. The posting date was November 16th, 2022 and the most recent edit was made on October 27th, 2022."
Answered by AI
How many total individuals are included in this clinical research project?
"In order to move forward, this clinical study requires 88 individuals that meet the pre-specified inclusion criteria. These potential participants can be located at various trial sites, such as Cone Health Cancer Center in Greensboro, North carolina and Monument Health Rapid City Hospital in South dakota."
Answered by AI
Is this clinical trial taking place at numerous locations across the United States?
"This trial is presently recruiting patients out of 10 sites. The sites are based in Rapid City, Greensboro and Urbana as well as 7 other locations. It is helpful to select the clinic closest you to minimize travel requirements if you participate."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
How old are they?
65+
What site did they apply to?
Cone Health Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
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