NCT07548476Recruiting
Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy
Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy (ACE)
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 17 Apr 2026
- Start date
- 3 Sept 2026
- Primary completion date
- 31 Aug 2028
- Lead sponsor
- Dana-Farber Cancer Institute
- Diseases
- Bladder cancer
- NCT number
- NCT07548476
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 3 Sept 2026 to the primary completion date, 31 Aug 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Receiving more than 10mg prednisone daily for any condition
Other illness
- 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
- History of bleeding diathesis (von Willebrand disease, hemophilia A/B)
- Known history of seizure disorder or taking antiepileptic drugs
Age
- Individuals who are not yet adults (infants, children, teenagers \< 18 years)
Other
- Having continued grade 2 or higher adverse effects of their current treatment (EV-Pembro)
- 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
- Pregnant people
- Prisoners
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.