NCT07548476 · Dana-Farber Cancer Institute
Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy
(ACE)
What this study is about
The goal of this study is to evaluate the feasibility and preliminary effectiveness 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).
View original scientific description
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).
Interventions
PROCEDURE
Acupuncture
Acupuncture treatment with licensed acupuncturist.
BEHAVIORAL
Exercise
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.
Primary outcome measures
Neuropathic Pain Scale (NPS) Score Change from Baseline
Time frame: At 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Boston, Massachusetts
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 20, 2026 · Source of record for eligibility and locations