Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy (NCT07548476) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy
United States50 participantsStarted 2026-10-02
Plain-language summary
The goal of this study is to evaluate the feasibility and preliminary efficacy of a combined acupuncture and exercise intervention for the management of chemotherapy-induced peripheral neuropathy (CIPN) in participants with metastatic bladder cancer receiving enfortumab vedotin (EV) and pembrolizumab (Pembro).
The names of the two study groups in this research study are:
* Acupuncture + Virtual Exercise (AVE)
* Virtual Exercise Only (VE)
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Age ≥ 18 years old
* Diagnosed with pathologically proven advanced or metastatic urothelial cancer (mUC)
* Planning to receive treatment with EV-Pembro or have received up to two cycles of EV-Pembro treatment with enrollment occurring prior to the start of the third cycle
* Self-reported ability to walk for 6 minutes and/or 2 blocks
* Deemed acceptable for exercise by their treating provider
* Sedentary, currently engaging in less than or equal to 60 minutes of moderate or vigorous structured exercise/week, as assessed by the Godin Leisure-Time Exercise Questionnaire
* Willing to adhere to all study-related procedures, including randomization to one of the two possible acupuncture treatments
* Eligible per verbally administered Physical Activity Readiness Questionnaire (PAR-Q+)
* Referrals to physical therapy are allowed during the study if necessary; and
* Participants taking any of medications listed below must be on a stable regimen, with no changes in the past three months. Use of these medications may continue while on study.
* Duloxetine, amitriptyline, nortriptyline, gabapentin, and pregabalin
Exclusion Criteria:
* History of peripheral neuropathy prior to EV-Pembro initiation
* Patients with a pacemaker or other electronically charged medical device; or
* Participate in more than 60 minutes of moderate or vigorous structured exercise/week
Investigators will not include the following special populations:
* Adults unable to consent
* Individua…
What they're measuring
1
Neuropathic Pain Scale (NPS) Score Change from Baseline