Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy
ACE
1 other identifier
interventional
50
1 country
1
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 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2026
CompletedFirst Posted
Study publicly available on registry
April 23, 2026
CompletedStudy Start
First participant enrolled
October 2, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2027
Study Completion
Last participant's last visit for all outcomes
March 2, 2027
May 4, 2026
April 1, 2026
5 months
April 17, 2026
April 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neuropathic Pain Scale (NPS) Score Change from Baseline
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.
At 12 weeks
Secondary Outcomes (10)
Brief Pain Inventory-Short Form (BPI-SF) Score Change from Baseline
Participants will complete BPI-SF survey at baseline, week 3, 6, 9 and 12.
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-Ntx) Score Change from Baseline
The FACT/GOG-Ntx will be completed at baseline, and weeks 3, 6, 9, and 12.
Chemotherapy-Induced Peripheral Neuropathy-20 (CIPN-20) Score Change from Baseline
CIPN-20 will be completed as baseline, week 6 and 12.
Quantitative Sensory Testing (QST) Scores Change from Baseline
QST will be completed at baseline and week 12 (PPT and CPM will be assessed at baseline only).
Relative Dose Intensity (RDI)
RDI calculated at 12 weeks.
- +5 more secondary outcomes
Study Arms (2)
Arm AVE: Acupuncture + Virtual Exercise
EXPERIMENTAL25 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
Arm VE: Virtual Exercise
ACTIVE COMPARATOR25 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 treatment with licensed acupuncturist.
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.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years old
- Diagnosed with pathologically proven advanced or metastatic urothelial cancer (mUC)
- Planning to receive treatment with EV-Pembro or have received up to two cycles of EV-Pembro treatment with enrollment occurring prior to the start of the third 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 one of the two possible acupuncture treatments
- Eligible per verbally administered Physical Activity Readiness Questionnaire (PAR-Q+)
- Referrals to physical therapy are allowed during the study if necessary; and
- 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
You may not qualify if:
- History of peripheral neuropathy prior to EV-Pembro initiation
- Patients with a pacemaker or other electronically charged medical device; or
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christina Dieli-Conwright, PhD, MPH
Dana-Farber Cancer Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 17, 2026
First Posted
April 23, 2026
Study Start (Estimated)
October 2, 2026
Primary Completion (Estimated)
March 2, 2027
Study Completion (Estimated)
March 2, 2027
Last Updated
May 4, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer office for Dana -Farber Innovations (BODFI) at innovations@dfci.harvard.edu
The Harvard Cancer Consortium encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.