Trial Outcomes & Findings for Study of Nicotine for Pain Associated With Chemotherapy-Induced Peripheral Neuropathy (NCT NCT04468230)

Last Updated: 2023-11-08

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

79 Days

Results posted on

2023-11-08

Participant Flow

Participant milestones

Participant milestones
Measure	Nicotine Transdermal Patch Administration 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). Nicotine Transdermal Patch: Nicotine Treatment Condition
Overall Study STARTED	4
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Nicotine Transdermal Patch Administration 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). Nicotine Transdermal Patch: Nicotine Treatment Condition
Overall Study Adverse Event	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 79 Days

Outcome measures

Outcome measures
Measure	Nicotine Transdermal Patch Administration n=3 Participants 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). Nicotine Transdermal Patch: Nicotine Treatment Condition
Efficacy of Short-term Nicotine Transdermal Patch Administration in the Treatment of Cancer Induced Peripheral Neuropathy (CIPN) 7mg patch	-7.7 score on a scale Standard Deviation 10.5
Efficacy of Short-term Nicotine Transdermal Patch Administration in the Treatment of Cancer Induced Peripheral Neuropathy (CIPN) 14 mg patch	-2.0 score on a scale Standard Deviation 5.0

SECONDARY outcome

Timeframe: 79 Days

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.

Outcome measures

Outcome measures
Measure	Nicotine Transdermal Patch Administration n=3 Participants 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). Nicotine Transdermal Patch: Nicotine Treatment Condition
Efficacy of Pain-related Changes and Degree of Functional Interference in the Treatment of CIPN 7 mg patch	-1.3 score on a scale Standard Deviation 2.1
Efficacy of Pain-related Changes and Degree of Functional Interference in the Treatment of CIPN 14 mg patch	-2.0 score on a scale Standard Deviation 1.7

SECONDARY outcome

Timeframe: 79 Days

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)

Outcome measures

Outcome measures
Measure	Nicotine Transdermal Patch Administration n=4 Participants 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). Nicotine Transdermal Patch: Nicotine Treatment Condition
Number of Participants at Risk and Affected by Adverse Events (AEs) Related to the Transdermal Nicotine Patch.	4 Participants

Adverse Events

Nicotine Transdermal Patch Administration

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nicotine Transdermal Patch Administration n=4 participants at risk 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). Nicotine Transdermal Patch: Nicotine Treatment Condition
Cardiac disorders Sinus Tachycardia	25.0% 1/4 • Number of events 2 • All adverse events (AE's) regardless of grade or attribution will be recorded from the beginning of study treatment (Cycle 1, Day 1 of nicotine transdermal patch administration) through the 30-day follow-up period.
Eye disorders Eye disorders- other	25.0% 1/4 • Number of events 1 • All adverse events (AE's) regardless of grade or attribution will be recorded from the beginning of study treatment (Cycle 1, Day 1 of nicotine transdermal patch administration) through the 30-day follow-up period.
Gastrointestinal disorders Constipation	25.0% 1/4 • Number of events 4 • All adverse events (AE's) regardless of grade or attribution will be recorded from the beginning of study treatment (Cycle 1, Day 1 of nicotine transdermal patch administration) through the 30-day follow-up period.
Gastrointestinal disorders Diarrhea	25.0% 1/4 • Number of events 1 • All adverse events (AE's) regardless of grade or attribution will be recorded from the beginning of study treatment (Cycle 1, Day 1 of nicotine transdermal patch administration) through the 30-day follow-up period.
Gastrointestinal disorders Nausea	100.0% 4/4 • Number of events 6 • All adverse events (AE's) regardless of grade or attribution will be recorded from the beginning of study treatment (Cycle 1, Day 1 of nicotine transdermal patch administration) through the 30-day follow-up period.
Gastrointestinal disorders Vomiting	50.0% 2/4 • Number of events 2 • All adverse events (AE's) regardless of grade or attribution will be recorded from the beginning of study treatment (Cycle 1, Day 1 of nicotine transdermal patch administration) through the 30-day follow-up period.
General disorders Edema Limbs	25.0% 1/4 • Number of events 1 • All adverse events (AE's) regardless of grade or attribution will be recorded from the beginning of study treatment (Cycle 1, Day 1 of nicotine transdermal patch administration) through the 30-day follow-up period.
General disorders Fatigue	25.0% 1/4 • Number of events 2 • All adverse events (AE's) regardless of grade or attribution will be recorded from the beginning of study treatment (Cycle 1, Day 1 of nicotine transdermal patch administration) through the 30-day follow-up period.
General disorders Fever	25.0% 1/4 • Number of events 1 • All adverse events (AE's) regardless of grade or attribution will be recorded from the beginning of study treatment (Cycle 1, Day 1 of nicotine transdermal patch administration) through the 30-day follow-up period.
Metabolism and nutrition disorders Dehydration	25.0% 1/4 • Number of events 1 • All adverse events (AE's) regardless of grade or attribution will be recorded from the beginning of study treatment (Cycle 1, Day 1 of nicotine transdermal patch administration) through the 30-day follow-up period.
Musculoskeletal and connective tissue disorders Arthralgia	25.0% 1/4 • Number of events 1 • All adverse events (AE's) regardless of grade or attribution will be recorded from the beginning of study treatment (Cycle 1, Day 1 of nicotine transdermal patch administration) through the 30-day follow-up period.
Nervous system disorders Dizziness	75.0% 3/4 • Number of events 5 • All adverse events (AE's) regardless of grade or attribution will be recorded from the beginning of study treatment (Cycle 1, Day 1 of nicotine transdermal patch administration) through the 30-day follow-up period.
Nervous system disorders Headache	75.0% 3/4 • Number of events 6 • All adverse events (AE's) regardless of grade or attribution will be recorded from the beginning of study treatment (Cycle 1, Day 1 of nicotine transdermal patch administration) through the 30-day follow-up period.
Nervous system disorders Nervous System Disorders, Other	50.0% 2/4 • Number of events 2 • All adverse events (AE's) regardless of grade or attribution will be recorded from the beginning of study treatment (Cycle 1, Day 1 of nicotine transdermal patch administration) through the 30-day follow-up period.
Nervous system disorders Paresthesia	25.0% 1/4 • Number of events 1 • All adverse events (AE's) regardless of grade or attribution will be recorded from the beginning of study treatment (Cycle 1, Day 1 of nicotine transdermal patch administration) through the 30-day follow-up period.
Nervous system disorders Somnolence	25.0% 1/4 • Number of events 1 • All adverse events (AE's) regardless of grade or attribution will be recorded from the beginning of study treatment (Cycle 1, Day 1 of nicotine transdermal patch administration) through the 30-day follow-up period.
Psychiatric disorders Depression	25.0% 1/4 • Number of events 1 • All adverse events (AE's) regardless of grade or attribution will be recorded from the beginning of study treatment (Cycle 1, Day 1 of nicotine transdermal patch administration) through the 30-day follow-up period.
Psychiatric disorders Insomnia	50.0% 2/4 • Number of events 2 • All adverse events (AE's) regardless of grade or attribution will be recorded from the beginning of study treatment (Cycle 1, Day 1 of nicotine transdermal patch administration) through the 30-day follow-up period.
Psychiatric disorders Irritability	25.0% 1/4 • Number of events 1 • All adverse events (AE's) regardless of grade or attribution will be recorded from the beginning of study treatment (Cycle 1, Day 1 of nicotine transdermal patch administration) through the 30-day follow-up period.
Skin and subcutaneous tissue disorders Pruritis	25.0% 1/4 • Number of events 2 • All adverse events (AE's) regardless of grade or attribution will be recorded from the beginning of study treatment (Cycle 1, Day 1 of nicotine transdermal patch administration) through the 30-day follow-up period.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders, other	50.0% 2/4 • Number of events 3 • All adverse events (AE's) regardless of grade or attribution will be recorded from the beginning of study treatment (Cycle 1, Day 1 of nicotine transdermal patch administration) through the 30-day follow-up period.

Additional Information

Renato Martins, MD

Virginia Commonwealth University

Phone: 804-828-1965

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place