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 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