What side effects are associated with this type of intervention?

Topical treatments for chemotherapy-induced peripheral neuropathy (CIPN) such as those containing amitriptyline, ketamine, and menthol have been explored for their potential benefits. Side effects of these topical agents are generally mild and may include local skin reactions like redness, itching, or irritation. In clinical trials, amitriptyline and ketamine creams have shown mixed results, with some studies indicating slight improvements in neuropathic symptoms, while others found no significant benefit. Menthol has shown promise in reducing pain and improving sensation in some patients. Overall, these treatments are considered relatively safe with minimal systemic side effects compared to oral or intravenous medications.

What prior FDA approvals exist?

The FDA has approved several treatments for peripheral neuropathy, though specific topical agents like WST-057 for chemotherapy-induced peripheral neuropathy (CIPN) are less common. Duloxetine is one FDA-approved drug for painful CIPN, demonstrating significant pain reduction in clinical trials. Other topical treatments, such as compounded creams containing amitriptyline and ketamine, have been studied but lack strong supporting data for FDA approval. Topical menthol has shown promise in case reports and small studies but is not specifically FDA-approved for CIPN. Overall, while there are FDA-approved systemic treatments for CIPN, topical agents like WST-057 are still largely in the investigational stage.

What other types of research exist?

Promising novel alternatives to WST-057 for Peripheral Neuropathy patients include investigational therapeutics for preventing oxaliplatin-induced neurotoxicity, as described in phase Ib randomized, double-blind, placebo-controlled, cross-over trials. Additionally, pharmacologic interventions for taxane-induced peripheral neuropathy (TIPN) are being explored, with revised assessment methods like the Total Neuropathy Score and the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity subscale showing potential for future use.

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Topical Cream for Peripheral Neuropathy

Phase 2

Waitlist Available

Research Sponsored by WinSanTor, Inc

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 19 weeks or 24 weeks for subjects on a chemotherapy dose delay

Summary

This trial tests a skin cream called WST-057 on patients receiving chemotherapy with Carboplatin and Paclitaxel. The cream is applied to the skin to help manage side effects from the chemotherapy. Carboplatin and Paclitaxel are frequently used together in treatments for various cancers, including gynecological malignancies.

Who is the study for?

Adults over 18 with advanced solid tumors undergoing chemotherapy (carboplatin and paclitaxel) can join. They must be able to fill out questionnaires, have a life expectancy of at least 6 months, an ECOG status of 0-2, and use effective contraception. Excluded are those with pre-existing neuropathy not from chemo, certain health conditions or treatments that could interfere with the study.

What is being tested?

The trial is testing WST-057, a topical treatment for chemotherapy-induced peripheral neuropathy against a placebo. Participants will apply it daily while receiving six cycles of carboplatin and paclitaxel chemotherapy over up to 24 weeks in this randomized, double-blind study.

What are the potential side effects?

Potential side effects may include skin reactions where WST-057 is applied. Since it's being compared to a placebo which has no active ingredients, any additional side effects would likely be related to individual sensitivities or underlying conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 19 weeks or 24 weeks for subjects on a chemotherapy dose delay

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~19 weeks or 24 weeks for subjects on a chemotherapy dose delay

This trial's timeline: 3 weeks for screening, Varies for treatment, and 19 weeks or 24 weeks for subjects on a chemotherapy dose delay for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Treatment-Emergent Adverse Events as assessed by ECG (measuring P Wave, QRS complex, QT interval)

Incidence of Treatment-Emergent Adverse Events as assessed by a dermal assessment (Draize score (scale 0.0-4.0) of the dosing area

Incidence of Treatment-Emergent Adverse Events as assessed by hematology and chemistry blood tests.

+3 more

Secondary study objectives

Activity and Fear of Falling Measurement (Short FES-I)

Chemotherapy dose modifications as assessed by median duration of delays (days) between chemotherapy treatments.

Chemotherapy dose modifications as assessed by percentage of patients requiring dose reductions of chemotherapy.

+15 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: WST-057 ActiveExperimental Treatment1 Intervention

Participants will apply 4 mL QD WST-057 Active topical solution.

Group II: PlaceboExperimental Treatment1 Intervention

Participants will apply 4 mL QD Placebo topical solution

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Peripheral Neuropathy treatments often target pain relief and nerve function improvement. Topical agents like lidocaine work by blocking sodium channels in nerve cells, reducing pain signal transmission. This is crucial for patients as it provides localized pain relief with minimal systemic side effects. Duloxetine, a systemic treatment, inhibits the reuptake of serotonin and norepinephrine, enhancing pain modulation pathways in the central nervous system. This dual action can be particularly beneficial for chemotherapy-induced peripheral neuropathy (CIPN) patients, as it addresses both pain and nerve function. The trial WST-057, involving a topical agent, aims to offer a targeted approach to mitigate CIPN, potentially enhancing patient comfort and treatment adherence by reducing debilitating side effects.