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Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy

RecruitingNA

Sponsor: Dana-Farber Cancer Institute

Conditions: Metastatic Bladder Cancer, Peripheral Neuropathy, Advanced Urothelial Cancer, Metastatic Urothelial Cancer, Bladder Cancer

Interventions: Acupuncture, Exercise

Countries: United States

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)

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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
* 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
* Having continued grade 2 or higher adverse effects of their current treatment (EV-Pembro)
* Receiving more than 10mg prednisone daily for any condition
* History of bleeding diathesis (von Willebrand disease, hemophilia A/B)
* Known history of seizure disorder or taking antiepileptic drugs
* 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

Locations (1)

Boston, Massachusetts, United States