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Acupuncture and Exercise for Nerve Damage in Bladder Cancer Treatment

Tests acupuncture with exercise for nerve problems in people receiving bladder cancer drugs.

Plain-language title generated from the registry record
Registry title: Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy

Key facts

Where
Boston, United StatesSee the site

Where in United States

  • Dana-Farber Cancer InstituteBoston, United StatesTaking people

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Trial details

Who runs it
Dana-Farber Cancer Institute
Trial code
NCT07548476
Record updated
26 October 2026
Original description
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 bladder cancer receiving enfortumab vedotin (EV) and pembrolizumab (Pembro).Read full original descriptionShow less

Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy (ACE)

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 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)

Inclusion: Age ≥ 18 years old; Diagnosed with pathologically proven urothelial cancer (UC); Have received at least one cycle of EV-Pembro treatment with enrollment occurring after the 1st cycle and prior to the 4th 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 either treatment group; Referrals to physical therapy are allowed during the study if necessary; 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; Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety of efficacy assessment of investigational regimen will be eligible.

Exclusion: History of documented grade 2 or greater peripheral or motor neuropathy prior to EV-Pembro initiation; may confound assessment of the intervention's preventative effect; Receiving more than 10mg prednisone daily for any condition; Patients with uncontrolled medical conditions that would preclude them from participating in moderate-to-vigorous intensity exercise in a virtual setting. Given the exercise environment is virtual, only patients with stable medical conditions should be enrolled to ensure their safety. Physical Activity Readiness Questionnaire (PARQ+) will be used during screening to facilitate conversations about present or historical medical conditions; History of bleeding diathesis (von Willebrand disease, hemophilia A/B); Known history of seizure disorder or taking antiepileptic drugs; Individuals who are not yet adults (infants, children, teenagers < 18 years); Having continued grade 2 or higher adverse effects of their current treatment (EV-Pembro); 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; Pregnant people; Prisoners.

ClinicalTrials.gov NCT07548476