Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy

{ "Acupuncture and Exercise for Chemotherapy-Induced Neuropathy in Bladder Cancer", "This study is looking at whether a combination of acupuncture and exercise can help manage peripheral neuropathy (nerve damage that can cause pain, numbness, or tingling) in people with metastatic bladder cancer. You might be able to join if you have advanced or metastatic urothelial cancer (a type of bladder cancer) and are receiving or about to start treatment with enfortumab vedotin (EV) and pembrolizumab (Pembro). The study aims to see if these interventions are practical and how well they work to reduce neuropathic pain. About 50 people will participate, but the current recruitment status is unclear.", "design": "This is an interventional study with about 50 participants, who will be randomly assigned to either receive acupuncture plus virtual exercise or virtual exercise only.", "commitments": "Participation involves screening, questionnaires, sensory tests, a cycling test, and physical performance tests, lasting about 12 weeks.", "compensation": "Not stated in the trial record.", "follow_up": "The primary outcome is measured at 12 weeks, which is the expected duration of participation.", }

Study design: Not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy

Recruiting

NAAges 18+InterventionalSupportive care

Dana-Farber Cancer Institute

~20 participants

Updated 2026-08-20 on ClinicalTrials.gov

What's tested:AcupunctureExercise

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Neuropathic Pain Scale (NPS) Score Change from Baseline

Measured over At 12 weeks

Conditions

Metastatic Bladder Cancer

Peripheral Neuropathy

Advanced Urothelial Cancer

Metastatic Urothelial Cancer

Bladder Cancer

Urothelial Cancer

Where it's being run

1 sites across 1 states

Massachusetts1

Study leadership

Christina Dieli-Conwright, PhD, MPH · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute

Who to contact

Christina Dieli-Conwright, PhD, MPH

[email protected]

617-582-8321

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

Adults unable to consent

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

Pregnant women

Prisoners

What this trial measures

Neuropathic Pain Scale (NPS) Score Change from BaselineAt 12 weeks
NPS is a multidimensional tool that uses a self-report numerical rating scale (0-10) to quantify global pain intensity, unpleasantness, and eight additional descriptive qualities of neuropathic pain, Scores on each 0-10 scale are patient-reported, with higher scores indicating greater pain intensity or unpleasantness. In addition, the NPS includes one semi-structured question that assesses the temporal sequence of pain.

Trialytics