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
Not Yet Recruiting

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Conditions

  • Advanced Urothelial Cancer
  • Metastatic Bladder Cancer
  • Metastatic Urothelial Cancer
  • Peripheral Neuropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Acupuncture — PROCEDURE
    Acupuncture treatment with licensed acupuncturist.
  • Exercise — 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

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 metastatic 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

Start date
Oct 2, 2026
Status verified
Apr 2026
Primary completion
Mar 2, 2027
Completion
Mar 2, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Arm AVE: Acupuncture + Virtual Exercise
    25 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
    25 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

Locations (1)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215
Christina Dieli-Conwright, PhD, MPH
[email protected]
617-632-3800
Christina Dieli-Conwright, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Dana Farber Cancer Institute· Boston, MA

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