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Exploring the Benefit of Topical Capsaicin in Treating Pain From Chemo-induced Peripheral Neuropathy: a Longitudinal Single Center Pilot Study
Phase < 1
Waitlist Available
Led By Saba Javed, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Participants diagnosed with pain of the lower extremity from chronic (\>90 days duration) CIPN (due to either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds), seen at MD Anderson Cancer Center
* Participants reporting baseline pain ≥ 4 (0-10 scale, NRS)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights
No Placebo-Only Group
Summary
To learn if topical capsaicin can help relieve pain from CIPN and improve gait (the pattern of walking) in patients.
Eligible Conditions
- Neuropathy
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety and adverse events (AE)s
Side effects data
From 2016 Phase 4 trial • 120 Patients • NCT0312440765%
Application site pain
18%
Application site pruritus
3%
Application site erythema
100%
80%
60%
40%
20%
0%
Study treatment Arm
QD-Active
QD-Vehicle
BID-Active
BID-Vehicle
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment with Qutenza Patch (Topical Capsaicin)Experimental Treatment1 Intervention
Up to 4 topical capsaicin patches will be applied on your feet for 30 minutes.
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Who is running the clinical trial?
Averitas Pharma, Inc.Industry Sponsor
3 Previous Clinical Trials
609 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,327 Total Patients Enrolled
Saba Javed, MDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
55 Total Patients Enrolled