Study of Nicotine for Pain Associated With Chemotherapy-Induced Peripheral Neuropathy (NCT04468230) | Clinical Trial Compass
TerminatedPhase 2
Study of Nicotine for Pain Associated With Chemotherapy-Induced Peripheral Neuropathy
Stopped: Low Accrual Rate
United States4 participantsStarted 2020-07-31
Plain-language summary
Assess the efficacy of short-term nicotine transdermal patch administration for the treatment of chemotherapy-induced peripheral neuropathy (CIPN) in cancer stable patients or patients in remission.
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:
* Clinically diagnosed peripheral sensory neuropathy defined as:
* Greater than Grade 1 peripheral sensory neuropathy using the CTCAE v5.0 grading scale
* Grade 1 Asymptomatic
* Grade 2 Moderate symptoms; limiting instrumental activities of daily living (ADL)
* Grade 3 Severe symptoms; limiting self-care ADL
* Grade 4 Life-threatening consequences; urgent intervention indicated
* Have a baseline chemotherapy-induced peripheral neuropathy (CIPN) patient reported outcome (PRO) total sensory score ≥ 24.3 on a 19 to 76 scale using the European Organization for Research and Treatment of Cancer Quality of Life-CIPN20 Questionnaire (EORTC QLQ-CIPN-20)
* Have a CIPN-related neuropathic pain score ≥ 4 on a 0 to 10 scale using the Brief Pain Inventory-Short Form (BPI-SF) item 5
* Will not have used any nicotine or tobacco products (eg, cigarettes, electronic cigarettes, smokeless tobacco, or other nicotine replacement therapies) within 14 days prior to study treatment start date
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Not currently receiving any chemotherapy
* Have previously received platinum- and/or taxane-based chemotherapy treatments and have persistent pain at least 3 months after completion of treatments.
* Willing and able to comply with study procedures and visit schedule.
* Willing to abstain from all tobacco/nicotine product use during study treatment and 30-day follow-up period.
* Ability to self-apply or h…
What they're measuring
1
Efficacy of Short-term Nicotine Transdermal Patch Administration in the Treatment of Cancer Induced Peripheral Neuropathy (CIPN)