Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy

NCT07548476 | Recruiting

• 1 other identifier: 25-454
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 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 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)

Conditions

Metastatic Bladder Cancer; Peripheral Neuropathy; Advanced Urothelial Cancer; Metastatic Urothelial Cancer; Bladder Cancer; Urothelial Cancer

Keywords

Enfortumab Vedotin-Induced Neuropathy; Pembrolizumab-Induced Neuropathy; mUC; UC

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.

Study Arms (2)

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

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

Behavioral: Exercise

Interventions

Acupuncture PROCEDURE

Acupuncture treatment with licensed acupuncturist.

Arm AVE: Acupuncture + Virtual Exercise

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.

Arm AVE: Acupuncture + Virtual Exercise; Arm VE: Virtual Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Peripheral Nervous System Diseases

Interventions

Acupuncture Therapy; Exercise

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Christina Dieli-Conwright, PhD, MPH

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Dieli-Conwright, PhD, MPH

CONTACT

617-582-8321; ChristinaM_Dieli-Conwright@dfci.harvard.edu

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: September 3, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: September 10, 2026

Record last verified: 2026-08

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

Locations

US (1)