Brief Title: Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Neuropathic Pain Scale (NPS) Score Change from Baseline

Primary Outcome 1 - Timeframe: At 12 weeks

CONDITION

• Metastatic Bladder Cancer
• Peripheral Neuropathy
• Advanced Urothelial Cancer
• Metastatic Urothelial Cancer
• Bladder Cancer
• Urothelial Cancer

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Christina Dieli-Conwright, PhD, MPH

Role: Principal Investigator

Affiliation: Dana-Farber Cancer Institute

Overall Contact

Name: Christina Dieli-Conwright, PhD, MPH

Phone: 617-582-8321

Email: [email protected]

LOCATION