Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy
Starting soon · Not applicable
Conditions studied: Metastatic Bladder Cancer, Peripheral Neuropathy, Advanced Urothelial Cancer, Metastatic Urothelial Cancer
In brief
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)
Key facts
- Study ID
- NCT07548476
- Run by
- Dana-Farber Cancer Institute
- People needed
- 50
- Starts
- 2026-10-02
- Expected to finish
- 2027-03-02
- Last updated by the study team
- 2026-05-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Individuals who are not yet adults (infants, children, teenagers < 18 years)
- Pregnant women
- Prisoners
Where it is running
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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