An interventional study of Acupuncture and Exercise in Metastatic Bladder Cancer, Peripheral Neuropathy and Advanced Urothelial Cancer, sponsored by Dana-Farber Cancer Institute. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Dana-Farber Cancer Institute · Not applicable, Interventional, and Supportive care
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:
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.
1,798 studies on the registry are indexed under Urinary Bladder Neoplasms; 445 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 1,296 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Dana-Farber Cancer Institute is the lead sponsor of 834 studies on the registry; 122 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 78 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 26, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Investigators will not include the following special populations:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Procedure: Acupuncture · Behavioral: 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
Behavioral: Exercise
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.
This study also gives Pembrolizumab, Enfortumab vedotin. No intervention listed here names it: that was found by reading the record.
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.
Time frame: At 12 weeks
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Assessed at 3, 6, and 12 weeks
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
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
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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