Recruiting

Acupuncture & Exercise

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT07548476

Conditions

Metastatic Bladder Cancer

Peripheral Neuropathy

Advanced Urothelial Cancer

Metastatic Urothelial Cancer

Bladder Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Acupuncture

Exercise

Study Details

Brief summary:

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

Metastatic Bladder Cancer

Peripheral Neuropathy

Advanced Urothelial Cancer

Metastatic Urothelial Cancer

Bladder Cancer

Study ID

NCT07548476

Start date

Aug, 2026

Status verified date

Aug, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Arm AVE: Acupuncture + Virtual Exercise

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

active comparator: Arm VE: Virtual Exercise

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

Interventions

Acupuncture

Acupuncture treatment with licensed acupuncturist.

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 measure

  • Neuropathic Pain Scale (NPS) Score Change from Baseline [ Time Frame: At 12 weeks ]

Central Contacts and Locations

Central contacts

Christina Dieli-Conwright, PhD, MPH

617-582-8321ChristinaM_Dieli-Conwright@dfci.harvard.edu

Locations

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Christina Dieli-Conwright, PhD, MPH

617-632-3800ChristinaM_Dieli-Conwright@dfci.harvard.edu

Principal Investigator:

Christina Dieli-Conwright, PhD

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • Enfortumab Vedotin-Induced Neuropathy
  • Pembrolizumab-Induced Neuropathy
  • mUC
  • UC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-08-20.