Metastatic Bladder CancerACENCT07548476
Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy
A study testing Acupuncture and Exercise in people with Metastatic Bladder Cancer and Peripheral Neuropathy, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Bladder Cancer, Peripheral Neuropathy, Advanced Urothelial Cancer
- What is being tested?
- Acupuncture and Exercise
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2026to Aug 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Christina Dieli-Conwright, PhD, MPH, 617-632-3800, ChristinaM_Dieli-Conwright@dfci.harvard.edu
Christina Dieli-Conwright, PhD
About this study
Official title: Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy (ACE)
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)
Read the detailed description
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).
CIPN is a side effect of some kinds of chemotherapy, and can lead to pain, numbness, tingling, swelling, or muscle weakness, primarily in the hands and feet and may persist for months or even years after chemotherapy ends.
Acupuncture involves using tiny needles to stimulate nerves and pathways in the body, and early research shows it might be helpful in reducing symptoms of CIPN.
Participants will be randomized in a 1:1 fashion into one of two study groups: AVE Arm: Acupuncture + Virtual Exercise or VE Arm: Virtual Exercise Only. Randomization means a participant is placed into a study group by chance.
The research study procedures include screening for eligibility, questionnaires, sensory tests, cycling test, and physical performance tests.
Participation in this research study is expected to last about 12 weeks.
About 20 people will take part in this study.
- Conditions
- Metastatic Bladder Cancer, Peripheral Neuropathy, Advanced Urothelial Cancer, Metastatic Urothelial Cancer, Bladder Cancer, Urothelial Cancer
- Being tested
- Acupuncture, Exercise
- Keywords
- Enfortumab Vedotin-Induced Neuropathy, Pembrolizumab-Induced Neuropathy, mUC, UC
- Medical subject headings
- Urinary Bladder Neoplasms, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Acupuncture treatment with licensed acupuncturist.
ExerciseBehavioural
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 group | Role | What they receive |
|---|---|---|
| Arm AVE: Acupuncture + Virtual Exercise | Experimental | 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 Receives: Procedure: Acupuncture; Behavioral: Exercise |
| Arm VE: Virtual Exercise | Active comparator | 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 Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 12 weeks
Secondary outcomes (10)
Brief Pain Inventory-Short Form (BPI-SF) Score Change from Baseline
BPI-SF is a validated self-report questionnaire that assesses pain severity and pain-related interference with daily functioning. Each item is rated on a 0-10 scale, with higher scores indicating greater pain severity or interference.
Measured: 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 is a patient-reported questionnaire developed to assess chemotherapy-induced peripheral neuropathy (CIPN). It includes an 11-item neurotoxicity (Ntx) subscale that evaluates sensory, motor, and hearing neuropathy, as well as functional impairments associated with neuropathy. Scores are rated on a Likert-type scale, with higher scores indicating better functioning and fewer/less severe neuropathy symptoms.
Measured: 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 is a patient-reported quality of life questionnaire consisting of 20 items that assess sensory, motor, and autonomic symptoms associated with chemotherapy-induced peripheral neuropathy. Items are rated on a 4-point Likert scale, and all scale scores are linearly converted to a 0-100 scale, with higher scores indicating greater symptom burden
Measured: CIPN-20 will be completed as baseline, week 6 and 12.
Quantitative Sensory Testing (QST) Scores Change from Baseline
Quantitative sensory testing (QST) objectively evaluates sensory nerve function and pain processing across several measurable modalities. Tactile detection is tested with Von Frey filaments (0.008-300 g), vibration with a biothesiometer (0-50 V), and thermal detection/pain thresholds with a TSA-II device (0-50°C) for warm, cool, heat-pain, and cold-pain responses. Mechanical pain threshold is measured using pinprick stimulators (8-512 mN). Conditioned pain modulation is calculated from the change in 0-100 pain ratings for heat stimuli given before versus during cold-water exposure. Pressure pain threshold is assessed at the thumbnail using controlled pressure from 0.25 to 10 kgf/cm². Higher values generally indicate less pain sensitivity or higher detection thresholds; lower values suggest greater pain sensitivity or sensory impairment.
Measured: QST will be completed at baseline and week 12 (PPT and CPM will be assessed at baseline only).
Relative Dose Intensity (RDI)
The planned total dose (PTD) of EV-Pembro therapy is defined as the total dose scheduled to be administered divided by the planned duration of therapy. The actual total dose (ATD) represents the average dose administered over the participant's actual treatment period. Relative dose intensity (RDI) is expressed as the actual dose intensity as a percentage of the planned dose intensity (ATD relative to PTD)
Measured: RDI calculated at 12 weeks.
Treatment Delays Rate (TDR)
TDR is defined as the proportion of participants who experienced one or more deviations from the planned dosing schedule for EV-Pembro during the treatment period.
Measured: Up to 12 weeks
Treatment Related Adverse Event (AE) Rate
Treatment related AE rate is defined as the proportion of participants experienced at least one treatment related AE. Events assessed as possibly, probably, or definitely related will be counted as treatment-related. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, version 5.0).
Measured: Up to 12 weeks
Early Discontinuation Rates (EDR)
EDR is defined as the proportion of participants who stopped EV or Pembrolizumab before completing the planned 12-week treatment for any reason.
Measured: At 12 weeks
Weekly Exercise Session Completion Rates
The weekly exercise session completion rate is defined as the proportion of prescribed exercise sessions completed by each participant during the 12-week intervention
Measured: Assessed weekly during the 12-week intervention.
Program Retention Rate
Program retention rate is defined as the proportion of participants who remain enrolled and actively participating in the exercise program.
Measured: Assessed at 3, 6, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start3 Sep 2026
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Bladder CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Dieli-Conwright, PhD, Dana-Farber Cancer Institute
- Investigators
- Christina Dieli-Conwright, PhD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548476
- Sponsor's protocol ID
- 25-454
- Acronym
- ACE
- Status last verified
- Aug 2026
- First submitted
- 17 Apr 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.