NeuropathyPhase 2NCT04468230
Study of Nicotine for Pain Associated With Chemotherapy-Induced Peripheral Neuropathy
A Phase 2 study testing Nicotine Transdermal Patch in people with Neuropathy and Peripheral Neuropathy, run by Virginia Commonwealth University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathy, Peripheral Neuropathy, Neuropathic Pain
- What is being tested?
- Nicotine Transdermal Patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Jul 2020to 31 May 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- History of pre-existing peripheral sensory neuropathies related to the following:
- Autoimmune disease
- B12/folate deficiency
- Diabetes Mellitus
- Human immunodeficiency virus (HIV)
- Hyper/hypothyroidism
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- 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:
- Systolic blood pressure (SBP) ≥ 140; Diastolic blood pressure (DBP) ≥ 90
- SBP ≤ 90; DBP ≤ 60
- Regular use of the following medications:
- Varenicline
- Bupropion (ie, bupropion hydrochloride sustained release)
- Women will be excluded if they are breastfeeding or are pregnant (by urinalysis) within 14 days prior to the start of nicotine transdermal patch administration.
- Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Virginia Commonwealth University
Richmond, Virginia, 23298
VCU Community Memorial Healthcenter
Richmond, Virginia, 23950
About this study
Official title: Phase 2 Study of Nicotine for the Treatment of Pain Associated With Chemotherapy-Induced Peripheral Neuropathy
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.
Read the detailed description
This phase 2 study will test the efficacy of short-term transdermal nicotine transdermal patch administration in patients who have been diagnosed with CIPN. The study will follow an open-label, crossover within-subjects clinical trial design with nicotine transdermal patch.
- Conditions
- Neuropathy, Peripheral Neuropathy, Neuropathic Pain, Chemotherapy-induced Peripheral Neuropathy
- Being tested
- Nicotine Transdermal Patch
- Keywords
- Nicotine, Peripheral Neuropathy
- Medical subject headings
- Peripheral Nervous System Diseases, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine Transdermal PatchDrug
Nicotine Treatment Condition
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Nicotine Transdermal Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 79 Days
Secondary outcomes (2)
Efficacy of Pain-related Changes and Degree of Functional Interference in the Treatment of CIPN
To assess the efficacy of short-term nicotine transdermal patch administration in the treatment of CIPN in patients whose cancer is stable or in remission by assessing changes in the degree of pain-related functional interference measured by the Brief Pain Inventory - Short Form (BPI-SF) interference score. The BPI-SF contains 4 items assessing average, worst, least, and immediate pain severity in the last 24 hours. Pain severity items are scored using an 11-point numeric rating scale (0, no pain; 10, pain as bad as you can imagine). Seven BPI-SF items will be used to quantify the degree to which pain interferes with daily activities or function (0, does not interfere; 10, completely interferes). The 7 items are summed to obtain a total interference score.
Measured: 79 Days
Number of Participants at Risk and Affected by Adverse Events (AEs) Related to the Transdermal Nicotine Patch.
To assess the AEs profile of nicotine transdermal patch administration for the treatment of CIPN in patients whose cancer is stable or in remission. The Adverse events (AEs) are reported using criteria in the National Cancer Institute Common Terminology Criteria for Adverse Events Version (CTCAE v 5.0)
Measured: 79 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start31 Jul 2020
- Primary completion31 May 2022
- Study completion31 May 2022
Why it stopped: Low Accrual Rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NeuropathyStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renato Martins, MD, Principal investigator, Massey Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04468230
- Sponsor's protocol ID
- MCC-16-12518
- Status last verified
- Oct 2023
- First submitted
- 7 Jul 2020
- Last updated
- 8 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Nicotine for the Treatment of Pain Associated With Chemotherapy-Induced Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT04468230
- Acronym / sponsor ID
- MCC-16-12518
- Conditions
- Neuropathy, Peripheral Neuropathy, Neuropathic Pain, Chemotherapy-induced Peripheral Neuropathy
- Keywords
- Nicotine, Peripheral Neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low Accrual Rate
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 31 Jul 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 13 Jul 2020 (actual)
- Results
- Posted 8 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This phase 2 study will test the efficacy of short-term transdermal nicotine transdermal patch administration in patients who have been diagnosed with CIPN. The study will follow an open-label, crossover within-subjects clinical trial design with nicotine transdermal patch.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nicotine Transdermal Patch Administration | Experimental | Drug: Nicotine Transdermal PatchEach 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Clinically diagnosed peripheral sensory neuropathy defined as:
- Greater than Grade 1 peripheral sensory neuropathy using the CTCAE v5.0 grading scale
- 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
Key exclusion criteria (22 listed)
- History of pre-existing peripheral sensory neuropathies related to the following:
- 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:
- New York Heart Association (NYHA) class III or IV congestive heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine Transdermal PatchNicotine Treatment Condition | Drug | Nicotine Transdermal Patch Administration |
Primary outcome
Efficacy of Short-term Nicotine Transdermal Patch Administration in the Treatment of Cancer Induced Peripheral Neuropathy (CIPN)
Time frame: 79 Days
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.
2 secondary outcomes
Efficacy of Pain-related Changes and Degree of Functional Interference in the Treatment of CIPN
Time frame: 79 Days
Number of Participants at Risk and Affected by Adverse Events (AEs) Related to the Transdermal Nicotine Patch.
Time frame: 79 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renato Martins, MD principal investigator
Massey Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nicotine Transdermal Patch in people with Neuropathy and Peripheral Neuropathy, run by Virginia Commonwealth University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Short-term Nicotine Transdermal Patch Administration in the Treatment of Cancer Induced Peripheral Neuropathy (CIPN) (time frame: 79 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.