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NCT05246670 · ClinicalTrials.gov registry record · Phase 2
PEA for the Relief of Chemotherapy-Induced Peripheral Neuropathy
A Phase 2 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, sponsored by Academic and Community Cancer Research United.
- Active
- Registry status
- Phase 2
- Development phase
- 88
- Enrollment target
- 10
- Study locations
NCT05246670: Active Phase 2 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, sponsored by Academic and Community Cancer Research United.
NCT05246670 is a Phase 2 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm that is active but no longer recruiting, run by Academic and Community Cancer Research United. The registered enrollment target is 88 participants, below the 1,140-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (92% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05246670, a Phase 2 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, is active but no longer recruiting, sponsored by Academic and Community Cancer Research United.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 88 participants
- Enrollment target
- 10
- Study locations
Study 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.
Primary Outcome
Will be scored and summarized at each time point for each patient. The change from baseline to 8 weeks will then be calculated for each patient. The mean, standard deviation, and median (range) of the change will be calculated for each PEA arm and the combined placebo arm. The difference in change scores between each PEA arm and the combined placebo will be estimated along with a 95% confidence interval. For the primary analysis, the CIPN20 analysis dataset will include all eligible patients who
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- DRUG Placebo Administration
- DRUG Palmidrol
Study Locations (10)
Wisconsin
- Mayo Clinic Health System Eau Claire Hospital-Luther Campus - Eau Claire
- Mayo Clinic Health System-Franciscan Healthcare - La Crosse
Connecticut
- Middlesex Hospital - Middletown
Illinois
- Carle Cancer Center NCI Community Oncology Research Program - Urbana
Iowa
- Siouxland Regional Cancer Center - Sioux City
Minnesota
- Mayo Clinic - Rochester
North Carolina
- Cone Health Cancer Center - Greensboro
Pennsylvania
- Geisinger Medical Center - Danville
South Dakota
- Rapid City Regional Hospital - Rapid City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2022-05-16 |
| Est. Completion | 2026-02-28 |
| Phase | Phase 2 |
What the registry record for NCT05246670 still lists
NCT05246670 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 1,140-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (92% lower).
The record links to 3 conditions, with Malignant Solid Neoplasm appearing as the primary indexed condition, and to 3 interventions - of which Quality-of-Life Assessment is the first listed.
NCT05246670 lists 10 locations in 9 states (Wisconsin, Connecticut, Illinois).
Frequently Asked Questions
What is clinical trial NCT05246670 about?
NCT05246670 is a clinical study titled "PEA for the Relief of Chemotherapy-Induced Peripheral Neuropathy". 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...
What is the current status of trial NCT05246670?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 88 participants. The study started on 2022-05-16. Estimated completion is 2026-02-28.
What conditions does trial NCT05246670 study?
This clinical trial studies the following conditions: Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, Chemotherapy-induced Peripheral Neuropathy.
What interventions are being tested in trial NCT05246670?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Placebo Administration (DRUG), Palmidrol (DRUG).
Who is sponsoring clinical trial NCT05246670?
This trial is sponsored by Academic and Community Cancer Research United, which has 42 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05246670 being conducted?
This trial has 10 study locations across Connecticut, Illinois, Iowa, Minnesota, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Malignant Solid Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05246670's enrollment target sits among peer trials
88 95th of 176 higher than 82 of 176 other Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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