What this study is
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)
What's being tested
- Acupuncture
Intervention · PROCEDURE
Acupuncture treatment with licensed acupuncturist.
- Exercise
Intervention · BEHAVIORAL
Virtually supervised, technology-based aerobic and resistance exercise program. Exercise bike and resistance bands will be provided to participants. Exercise sessions will be via HIPAA-compliant, teleconference platform Zoom.
Study details
- Official title
- Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy (ACE)
- Sponsor
- Dana-Farber Cancer Institute
- Conditions
- Metastatic Bladder Cancer · Peripheral Neuropathy · Advanced Urothelial Cancer · Metastatic Urothelial Cancer · Bladder Cancer · Urothelial Cancer
- Enrolling
- 20 people
- Starts
- 2026-09-03
- Est. completion
- 2028-08
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openDana Farber Cancer Institute
Boston, Massachusetts, United States
- Christina Dieli-Conwright, PhD, MPH · Contact617-632-3800ChristinaM_Dieli-Conwright@dfci.harvard.edu
- Christina Dieli-Conwright, PhD · Principal investigator
Recruiting
Study team
Sponsor
Dana-Farber Cancer Institute
Study ID 25-454
Principal investigator
Christina Dieli-Conwright, PhD, MPH
Dana-Farber Cancer Institute
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.