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Naloxone Hydrochloride Lotion, 0.5%

Placebo Lotion

Scott B Phillips, MD

This multi-center, double-blind, vehicle-controlled, randomized crossover design study will evaluate the safety and efficacy of topically applied naloxone lotion, 0.5%, for the treatment of pruritus in patients with the mycosis fungoides (MF) or Sézary syndrome (SS) Forms of Cutaneous T-cell Lymphoma (CTCL). This study will also determine if there is systemic absorption of the drug in a subset of subjects and if so, describe the range and mean plasma levels reached after two weeks of three time daily (TID) dosing.

Funding Source - FDA OOPD

There will be 160 subjects enrolled in the study. The study consists of a Screening Period of up to 7 days during which inclusion / exclusion criteria will be reviewed. Subjects meeting inclusion / exclusion criteria including the diagnostic criteria for MF or SS and a score of at least 5 on the 11-Point Numeric Rating Scale (NRS) for Pruritus will complete the one week Screening Period. Subjects will complete a daily diary for NRS for Pruritus scores and Sleep scores. At the end of the Screening Period, subjects who have a NRS for Pruritus score of at least 5 recorded in the diary on at least 4 of the 7 days preceding Day 0 will be eligible to continue. Baseline assessments will be recorded for vital signs, pruritic body surface area, skin integrity, PQOL, and laboratory results. The Baseline period will be followed by a 2 week Treatment Period 1 in which subjects will be randomized to Naloxone Lotion 0.5% or Placebo Lotion to be applied TID for 14 days. During the 2 week Treatment Period subjects will complete daily diaries of NRS for Pruritis scores and Sleep scores. On Day 14 subjects will return to the clinic to review diaries, adverse events (AEs), concomitant medications, and to record body surface area for pruritus, skin integrity, PQOL, and laboratory results. Subjects will then enter a Washout Period for up to 56 days until the subject again scores at least 5 on the NRS for Pruritus on 4 consecutive or 4 of the past 7 days or 56 days pass. Subjects will then enter a 2 week Treatment Period 2 during which the same procedures as Treatment Period 1 will be performed except subjects will receive the alternate treatment to that assigned in Treatment Period 1. Subjects will then have the option to enter a 26 Week Open Label Treatment Period 3 during which the same procedures as Treatment Period 1 and 2 will be performed except subjects will return only at Week 13 and Week 26 and all subjects will be treated with Naloxone Lotion 0.5%.

Naloxone Hydrochloride Study for Relief of Pruritus in Patients With MF or SS Forms of CTCL

A Double Blind Randomized Vehicle Controlled Crossover Study to Evaluate the Safety and Efficacy of Topical Naloxone Hydrochloride Lotion 0.5% for the Relief of Pruritus in Patients With the MF or SS Forms of Cutaneous T-Cell Lymphoma

Change from Baseline to Day 14 in average NRS for Pruritus for each Treatment Period

The difference in the proportion of subjects with a meaningful clinically significant improvement at the end of the two periods. A clinically significant improvement is defined as an improvement of at least one category on the 4-point (none, mild, moderate, severe) Likert Scale verbal rating scale (VRS) and at least two points on the 11-point NRS for Pruritus. The NRS for Pruritus scores will be converted to VRS scores as follows for the analysis: 0=none, 1-3=mild, 4-6=moderate, and 7-10=severe.

The change from Baseline at each week of the NRS for Sleep average score for each Treatment Period.

The change from Baseline at Week 1 of the NRS for Pruritus average score for each Treatment Period.

The change from Baseline at Week 2 of the CRS for Skin Integrity for each Treatment Period.

The change from Baseline in the final categorization of the PQOL at Day 14 of each Treatment Period

Elorac, Inc.

Nervous System Diseases

Breast Neoplasms

Peripheral Nervous System Diseases

Neuromuscular Diseases

Dermatologic Agents

Antirheumatic Agents

Menthol

Methyl salicylate

Patients with neuropathic pain will receive topical menthol following or during chemotherapy for the treatment of either breast, gastrointestinal, or gynecologic cancer.

Patients with neuropathic pain will receive placebo lotion following or during chemotherapy for the treatment of either breast, gastrointestinal, or gynecologic cancer.

7.5% Methylsalicylate / 2% Menthol Lotion

topical menthol

The control (placebo) product has same amount of Methylsalicylate (7.5%) and no menthol.

placebo lotion

Dawn Hershman, MD

Primary Objective: To assess whether six-week treatment with twice daily topical Menthol application will decrease neuropathic pain as measured by the change in Brief Pain Inventory-Short Form (BPI-SF worst pain score), following or during neoadjuvant/adjuvant chemotherapy with taxane or platinum-based regimens among breast, gastrointestinal or gynecologic cancer patients.

Secondary objectives:

* To compare change in patient-reported outcomes: overall BPI-SF scales, EORTC-CIPN20, European Organization for Research and Treatment of Cancer Chemotherapy Quality of Life Questionnaire (EORTC QLQ-C30), Patient-Reported Outcomes Measurement Information System (PROMIS-29) scores between study groups.
* To compare changes in dose delivery and early treatment discontinuation rates between study groups.
* To compare objective sensory and motor functional change from baseline with the use of quantitative neurosensory testing.
* To perform an exploratory analysis evaluating the interaction between treatment and chemotherapy type.

Chemotherapy induced peripheral neuropathy (CIPN): CIPN is a debilitating and often irreversible toxicity associated with various chemotherapy agents widely used in the treatment of both solid tumors and hematologic malignancies. Clinical trials with Taxane-based forms of chemotherapy, commonly used in the adjuvant treatment of breast cancer, have reported up to 33% grades 2-3 sensory neuropathy and up to 14% of motor neuropathy. Severity is closely related to chemotherapy dose and schedule. CIPN may also develop in up to 64% of patients treated with 12 cycles of Oxaliplatin based adjuvant chemotherapy, when assessed clinically and electro physiologically. Patients develop an axonal, predominately sensory peripheral neuropathy, of mild to moderate severity. Thermal hyperalgesia with cold allodynia was found to be a clinical marker of early oxaliplatin neurotoxicity and may predict severe neuropathy

Topical Menthol for the Treatment of Chemotherapy Induced Peripheral Neuropathy

Topical Menthol for Chemotherapy Induced Peripheral Neuropathy (CIPN): A Randomized, Placebo Controlled Phase II Trial

The Brief Pain Inventory-Short Form (BPI-SF) is a well-validated clinical tool used frequently to assess severity of pain and its effect on daily functions in patients with neuropathy. The instrument gives several ratings of the intensity and severity of pain and the degree of pain interference on activity, mood, sleep, relations with others and work. The questionnaire uses a 0-10 scale with a higher score indicating a worse outcome.

The European Organization for Research and Treatment of Cancer Chemotherapy-induced peripheral neuropathy (EORTC-CIPN20) is a questionnaire measuring patient reported symptoms of chemotherapy induced neuropathy. Scores range from 20-80 with a higher score indicating a worse outcome.

Sensorimotor function as measured by a Bio-Thesiometer, which measures changes in vibratory perception. The Bio-Thesiometer is an electrical tuning fork whose amplitude can be gradually increased. Vibration threshold will be assessed at the dorsum of the distal interphalangeal joint of the index finger and dorsum of the interphalangeal joint of the hallux. Subjects will be asked to indicate when the vibration stimulus is initially felt (perception threshold) and when the stimulus disappears (disappearance threshold.) The vibration perception threshold is the average of three paired measurements.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Naloxone Hydrochloride Study for Relief of Pruritus in Patients With MF or SS Forms of CTCL	NCT02811783	Mycosis Fungoid... Lymphoma, T-Cel... Sézary Syndrome	Naloxone Hydroc... Placebo Lotion	21 Years -	Elorac, Inc.
Topical Menthol for the Treatment of Chemotherapy Induced Peripheral Neuropathy	NCT01855607	Breast Cancer Colon Cancer Neuropathy	topical menthol placebo lotion	21 Years -	Columbia University

Spots Global Cancer Trial Database for placebo lotion