Study of Nicotine for Pain Associated With Chemotherapy-Induced Peripheral Neuropathy

NCT04468230 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: MCC-16-12518
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Neuropathy; Peripheral Neuropathy; Neuropathic Pain; Chemotherapy-induced Peripheral Neuropathy

Keywords

Nicotine; Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• Efficacy of Short-term Nicotine Transdermal Patch Administration in the Treatment of Cancer Induced Peripheral Neuropathy (CIPN)

  To assess the efficacy, of the nicotine transdermal patch administration in the treatment of CIPN in patients whose cancer is stable or in remission as defined by a ≥ 2.7 point decrease in the total sensory score of the European Organization for Research and Treatment of Cancer Quality of Life-cancer induced peripheral neuropathy (CIPN20) Questionnaire (EORTC QLQ-CIPN-20) (eg, an improvement in the patients quality of life by one grade). The QLQ-CIPN20 numerical score has a range of 19-76, in which lower scores indicate less symptoms and a better quality of life.

  79 Days

Secondary Outcomes (2)

• Efficacy of Pain-related Changes and Degree of Functional Interference in the Treatment of CIPN

  79 Days

• Number of Participants at Risk and Affected by Adverse Events (AEs) Related to the Transdermal Nicotine Patch.

  79 Days

Study Arms (1)

Nicotine Transdermal Patch Administration

EXPERIMENTAL

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).

Drug: Nicotine Transdermal Patch

Interventions

Nicotine Transdermal Patch DRUG

Nicotine Treatment Condition

Nicotine Transdermal Patch Administration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 have the patch applied at home daily.

You may not qualify if:

• History of pre-existing peripheral sensory neuropathies related to the following:
• Autoimmune disease
• B12/folate deficiency
• Diabetes Mellitus
• Human immunodeficiency virus (HIV)
• Hyper/hypothyroidism
• Monoclonal gammopathy of undetermined significance or multiple myeloma
• History of receiving other types of neurotoxic chemotherapy drugs (eg, vinca alkaloids, bortezomib, thalidomide)
• Current or prior pheochromocytoma
• History of or active or clinically significant cardiac disease including any of the following:
• Unstable angina (eg, anginal symptoms at rest) or onset of angina within 3 months prior to initiating study treatment
• Myocardial infarction diagnosed within 6 months prior to initiating study treatment
• Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers
• New York Heart Association (NYHA) class III or IV congestive heart failure
• Poorly controlled high or low blood pressure defined as:

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (2)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

VCU Community Memorial Healthcenter

Richmond, Virginia, 23950, United States

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Neuralgia

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Limitations and Caveats

The Coronavirus-19 (COVID-19) pandemic caused reduced accrual rates. The protocol was terminated early due to slow accrual rates by the Protocol Review \& Monitoring Committee (PRMC).

Results Point of Contact

• Title: Renato Martins, MD
• Organization: Virginia Commonwealth University

MasseyCPC@vcu.edu

804-828-1965

Study Officials

• Renato Martins, MD

  Massey Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 13, 2020
• Study Start: July 31, 2020
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: November 8, 2023
• Results First Posted: November 8, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)