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 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)

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

- Individuals who are not yet adults (infants, children, teenagers < 18 years)

- Pregnant women

- Prisoners