Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy

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.

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.

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.

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) 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.

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)

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.

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).

EDR is defined as the proportion of participants who stopped EV or Pembrolizumab before completing the planned 12-week treatment for any reason.

The weekly exercise session completion rate is defined as the proportion of prescribed exercise sessions completed by each participant during the 12-week intervention

Program retention rate is defined as the proportion of participants who remain enrolled and actively participating in the exercise program.