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Nicotine Transdermal Patch for Peripheral Neuropathy

Phase 2
Waitlist Available
Led By Zhi-Jian Chen, MD, PhD
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 79 days
Awards & highlights

Study Summary

This trial will test whether a nicotine patch can help cancer patients with nerve pain.

Eligible Conditions
  • Chemotherapy-induced Peripheral Neuropathy
  • Peripheral Neuropathy
  • Neuropathic Pain
  • Neuropathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~79 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 79 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy of Short-term Nicotine Transdermal Patch Administration in the Treatment of Cancer Induced Peripheral Neuropathy (CIPN)
Secondary outcome measures
Efficacy of Pain-related Changes and Degree of Functional Interference in the Treatment of CIPN
Number of Participants at Risk and Affected by Adverse Events (AEs) Related to the Transdermal Nicotine Patch.

Side effects data

From 2016 Phase 4 trial • 36 Patients • NCT02681510
75%
Insomnia
72%
Vivid Dreams
64%
Nausea
42%
Mood Changes
39%
Dizziness
19%
Skin Rash
19%
Sweating
14%
Shortness of Breath
14%
Vomiting
11%
Chest Tightness
3%
Angina
100%
80%
60%
40%
20%
0%
Study treatment Arm
Three Drug Intervention

Trial Design

1Treatment groups
Experimental Treatment
Group I: Nicotine Transdermal Patch AdministrationExperimental Treatment1 Intervention
Each patient will complete two 14-day treatment conditions, for 7 mg nicotine transdermal patch administration with a washout period in between (≥ 14 days and up to 21 days), then 14 mg nicotine transdermal patch administration (14 days).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine Transdermal Patch
2016
Completed Phase 4
~190

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
698 Previous Clinical Trials
22,884,991 Total Patients Enrolled
2 Trials studying Peripheral Neuropathy
57 Patients Enrolled for Peripheral Neuropathy
Zhi-Jian Chen, MD, PhDPrincipal InvestigatorMassey Cancer Center
Renato Martins, MDPrincipal InvestigatorMassey Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers looking to add participants to this medical experiment?

"Yes, the clinical trial is recruiting from all sources. According to information hosted on clinicaltrials.gov, it was initially posted on July 31st 2020 and most recently amended on November 15th 2022."

Answered by AI

How many participants are receiving treatment through this clinical trial?

"Affirmative. Current records on clinicaltrials.gov assert that this medical research, which was first published on July 31st 2020, is actively seeking participants. Approximately 40 individuals need to be recruited from 2 separate sites of study."

Answered by AI

Has the Nicotine Transdermal Patch attained authorization by the FDA?

"Due to the Phase 2 trial status of Nicotine Transdermal Patch, our team at Power assigned a safety value of 2 out of 3 as prior clinical data indicates that it is safe but no evidence exists for efficacy."

Answered by AI

Are there any other research studies which have employed Nicotine Transdermal Patch?

"At this time, 71 clinical trials involving Nicotine Transdermal Patches are live with 5 of those in the final phase. Of these studies, 204 sites across locations such as Green Bay, Wisconsin are actively recruiting participants."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
How old are they?
18 - 65
What site did they apply to?
Virginia Commonwealth University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study of Nicotine for Pain Associated With Chemotherapy-Induced Peripheral Neuropathy
2020. "Study of Nicotine for Pain Associated With Chemotherapy-Induced Peripheral Neuropathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04468230.
~1 spots leftby Apr 2025
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