Study Summary
This trial will evaluate auricular point acupressure (APA) on chemotherapy-induced neuropathy (CIN), with the goal of understanding its efficacy and underlying mechanism(s).
Eligible Conditions
- Chemotherapy-Induced Neuropathy
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 4 Secondary · Reporting Duration: Up to 4 months
Up to 1 month
Change of brain activity as assessed by fMRI Neuroimaging
Up to 4 months
Change in anti-inflammatory cytokines as assessed by serum cytokine biomarkers
Change in numbness as assessed by the Brief Pain Inventory
Change in pain severity as assessed by the Brief Pain Inventory
Change in physical function as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29
Change in pro-inflammatory cytokines as assessed by serum cytokine biomarkers
Change in tingling as assessed by the Brief Pain Inventory
Change of pain sensitivity as assessed by Qualitative Sensory Testing (QST)
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
Usual Care Control
1 of 3
APA Group
1 of 3
Virtual APA group
1 of 3
Active Control
Experimental Treatment
240 Total Participants · 3 Treatment Groups
Primary Treatment: Virtual Auricular Point Acupressure (APA) · No Placebo Group · N/A
APA Group
Device
Experimental Group · 1 Intervention: Virtual Auricular Point Acupressure (APA) · Intervention Types: DeviceVirtual APA group
Other
Experimental Group · 1 Intervention: In-Person Training · Intervention Types: OtherUsual Care Control
Other
ActiveComparator Group · 1 Intervention: Usual Care · Intervention Types: OtherTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Virtual Auricular Point Acupressure (APA)
2021
N/A
~20
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 4 months
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,073 Previous Clinical Trials
31,016,985 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,070 Previous Clinical Trials
41,128,874 Total Patients Enrolled
M.D. Anderson Cancer CenterOTHER
2,802 Previous Clinical Trials
1,788,663 Total Patients Enrolled
University of TexasOTHER
173 Previous Clinical Trials
121,690 Total Patients Enrolled
Thomas Smith, MDPrincipal InvestigatorJohns Hopkins School of Medicine
2 Previous Clinical Trials
67 Total Patients Enrolled
Chao Hsing Yeh, PhDPrincipal InvestigatorJohns Hopkins School of Nursing
5 Previous Clinical Trials
606 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have one of the average intensity of pain, or numbness, or tingling on your extremities the previous week due to CIN ≥ 4 on a 11-point numerical scale.
You have cancer or pre-existing peripheral neuropathy of another etiology that worsened after chemotherapy.
References
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