Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Dana-Farber Cancer Institute
- Study ID
- NCT07548476
- Status
- Recruiting
Conditions
- Advanced Urothelial Cancer
- Bladder Cancer
- Metastatic Bladder Cancer
- Metastatic Urothelial Cancer
- Peripheral Neuropathy
- Urothelial Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Acupuncture — PROCEDUREAcupuncture treatment with licensed acupuncturist.
- Exercise — BEHAVIORALVirtually 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
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)
Key Dates
- First listed
- Apr 23, 2026
- Start date
- Aug 31, 2026
- Status verified
- Aug 2026
- Primary completion
- Aug 31, 2028
- Completion
- Aug 31, 2028
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Arm AVE: Acupuncture + Virtual Exercise10 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 Exercise10 participants will complete: * In-clinic baseline visit * 3 exercise sessions with certified trainer per week * One or two end of study in-clinic visits
Primary Outcome Measure
Neuropathic Pain Scale (NPS) Score Change from Baseline [ Time Frame: At 12 weeks ]
Central Contacts
- Christina Dieli-Conwright, PhD, MPH617-582-8321
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | Christina Dieli-Conwright, PhD (PRINCIPAL_INVESTIGATOR) |
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