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)
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
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
Parallel
Acupuncture
Procedure/SurgeryAcupuncture treatment with licensed acupuncturist.
Exercise
BehavioralVirtually 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.
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.
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.
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.
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
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.
Click on the lead sponsor to view all of their trials.
