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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
Awards & highlights
Study Summary
This trial is testing a new cancer treatment that involves a cream applied daily. The cream will be tested for safety and how well it works. The trial will last for up to 24 weeks.
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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
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 moreTrial 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
Find a Location
Who is running the clinical trial?
WinSanTor, IncLead Sponsor
3 Previous Clinical Trials
132 Total Patients Enrolled
1 Trials studying Peripheral Neuropathy
58 Patients Enrolled for Peripheral Neuropathy
Angela HansenStudy DirectorWinSanTor, Inc
3 Previous Clinical Trials
132 Total Patients Enrolled
1 Trials studying Peripheral Neuropathy
58 Patients Enrolled for Peripheral Neuropathy
Marian Ijzerman, Ph.DStudy DirectorWinSanTor, Inc
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am set to receive 6 cycles of chemotherapy with carboplatin and paclitaxel for my advanced cancer.I have nerve damage not caused by previous chemotherapy.I have problems emptying my bladder or an enlarged prostate.I am currently using pain relief creams or patches.I am over 18 years old.I have a major blood vessel disease that is currently affecting me.I need dialysis.You are able to understand the nature of a placebo-controlled trial and are able to sign informed consent.I can care for myself and am up and about more than half of my waking hours.I cannot complete the initial health checks required.I am scheduled for radiation therapy during the study.I need immediate treatment for my severe eye condition.I have diabetes and have been on a stable treatment for over 2 months.I have had a leg amputation or I have foot ulcers.I do not have any other serious illnesses that would interfere with the study.I can start vitamins and supplements if my doctor agrees.I currently have an infection that affects my whole body.I am taking medication for overactive bladder.I can take care of myself and am up and about more than half of my waking hours.I am allergic to anticholinergics or ingredients in the study drug.I agree to use contraception during the study if my partner could become pregnant.I am on regular pain meds like gabapentin, but short-term opioids for severe pain are okay.I am set to receive chemotherapy with carboplatin and paclitaxel for my advanced cancer, and may also get Avastin or Keytruda.My cancer is located in my head or neck.I have glaucoma that is not well-managed.My thyroid condition is not under control or treated.I have had a bleeding stroke in the past.I understand and can follow the study's requirements.I haven't taken more than 225 IU of Vitamin E daily in the last 30 days.I experience significant nerve pain or dysfunction.My high blood pressure is not under control.I am not pregnant, nursing, or if capable of childbearing, I am using effective birth control.I am not able to have children or am using effective birth control and have a negative pregnancy test.I am over 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: WST-057 Active
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacant slots available for participants in this study?
"Based on the data hosted by clinicaltrials.gov, this trial is presently inactive; it was posted on August 15th 2022 and updated most recently on August 3rd 2022. However, 161 other medical studies are actively accepting patients right now."
Answered by AI
Has the FDA certified WST-057 as clinically effective?
"The safety of WST-057 Active has been evaluated as a 2 on our 1 to 3 scale since the clinical trial is in its Phase 2, with some data indicating safety but no evidence yet demonstrating efficacy."
Answered by AI
What is the primary aim of this clinical experiment?
"The primary assessment for this trial, which will span 19 or 24 weeks depending on the chemotherapy dose delay per patient, is Treatment-Emergent Adverse Events as evidenced by hematology and chemistry blood tests. Secondary measurements include Intraepidermal Nerve Fiber Density (IENFD), Chemotherapy dose modifications with median duration of delays calculated in days, and Visual Analogue Score (VAS) based on self-reported pain ratings from 0 to 100 mm."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
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