Acupuncture and Exercise for EV-Pembro–Induced Peripheral Neuropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a feasibility study evaluating a combined acupuncture and virtual exercise program for managing CIPN in adults with urothelial cancer receiving enfortumab vedotin and pembrolizumab. Participants are randomized 1:1 to receive either acupuncture plus virtual exercise or virtual exercise alone over about 12 weeks. The study collects screening data, questionnaires, sensory and functional tests, and performance measures to gauge practicality and preliminary efficacy. Enrollment is expected to be around 20 participants at Dana-Farber Cancer Institute in Boston. Primary aims focus on feasibility; secondary observations include changes in CIPN symptoms and physical function.

Why it matters

Who can join: the full rules

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 people
* Prisoners

Where it's running

• Dana Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Christina Dieli-Conwright, PhD, MPH — Dana-Farber Cancer Institute
• Study coordinator: Christina Dieli-Conwright, PhD, MPH
• Email: ChristinaM_Dieli-Conwright@dfci.harvard.edu
• Phone: 617-582-8321

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.