Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy

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)

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).

CIPN is a side effect of some kinds of chemotherapy, and can lead to pain, numbness, tingling, swelling, or muscle weakness, primarily in the hands and feet and may persist for months or even years after chemotherapy ends.

Acupuncture involves using tiny needles to stimulate nerves and pathways in the body, and early research shows it might be helpful in reducing symptoms of CIPN.

Participants will be randomized in a 1:1 fashion into one of two study groups: AVE Arm: Acupuncture + Virtual Exercise or VE Arm: Virtual Exercise Only. Randomization means a participant is placed into a study group by chance.

The research study procedures include screening for eligibility, questionnaires, sensory tests, cycling test, and physical performance tests.

Participation in this research study is expected to last about 12 weeks.

About 20 people will take part in this study.

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