Clinical trial · Interventional
Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy
Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy (ACE)
NCT07548476CI-TRIAL-00123016ACErecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260911-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Urothelial Cancer | — | UNRESOLVED | — |
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Bladder Cancer | Malignant Bladder Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Urothelial Cancer | — | UNRESOLVED | — |
| Peripheral Neuropathy | — | UNRESOLVED | — |
| Urothelial Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acupuncture | Procedure | — | UNRESOLVED |
| Exercise | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm AVE: Acupuncture + Virtual Exercise
- description
- 10 participants will complete: * In-clinic baseline visit * 3 exercise sessions with certified trainer per week * 1 in-clinic acupuncture session per week * One or two end of study in-clinic visits
- interventionNames
- Procedure: Acupuncture
- Behavioral: Exercise
- type
- ACTIVE_COMPARATOR
- label
- Arm VE: Virtual Exercise
- description
- 10 participants will complete: * In-clinic baseline visit * 3 exercise sessions with certified trainer per week * One or two end of study in-clinic visits
- interventionNames
- Behavioral: Exercise
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 * Prisoners
References
Publications (0)
Data not yet available
No reference posted for this study.