Electroacupuncture and Exercise for Chemotherapy-Induced Peripheral Neuropathy (CIPN)

Primary outcomes

1. Total Neuropathy Score-reduced (TNS-r)

   Time frame: Baseline (Week 0), Mid-intervention (Week 4), and Post-intervention (Week 8).

   The Total Neuropathy Score-reduced (TNS-r) is a validated clinical composite scale used in this study to quantitatively assess the severity of chemotherapy-induced peripheral neuropathy (CIPN). It integrates patient-reported symptoms with objective clinical signs, including ankle reflexes, pinprick and vibration thresholds, muscle strength, and nerve conduction. The assessment evaluates seven items, each graded on a scale from 0 (normal or no symptoms) to 4 (very severe). This grading provides a standardized measure where higher scores indicate more severe peripheral nerve impairment and neurological symptoms. In this trial, the TNS-r serves as the primary outcome measure to determine if the combined electro-acupuncture and exercise intervention effectively reduces neurological symptoms and promotes nerve repair over the 8-week study period.

2. Mini-Balance Evaluation Systems Test (Mini-BESTest)

   Time frame: Baseline (Week 0), Mid-intervention (Week 4), and Post-intervention (Week 8).

   The Mini-Balance Evaluation Systems Test (Mini-BESTest) is a 14-item clinical instrument validated to quantitatively assess dynamic balance across four distinct contexts: anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. Each item is scored from 0 to 2, yielding a total score range of 0 to 28, where higher scores represent superior dynamic postural control, enhanced functional mobility, and a reduced risk of falls.

   In this trial, the Mini-BESTest serves as a co-primary outcome measure to evaluate the external functional rehabilitation efficacy of combining electroacupuncture with progressive multi-modal exercise training. It specifically detects improvements in dynamic postural stability, neuromuscular control, and proprioception over the 8-week intervention period.

3. Semmes-Weinstein Monofilaments

   Time frame: Baseline (Week 0), Mid-intervention (Week 4), and Post-intervention (Week 8).

   Tactile sensation and sensory thresholds are objectively measured at specific anatomical sites on the bilateral upper and lower extremities using Semmes-Weinstein Monofilaments (SWM). Results will be analyzed based on the smallest filament size perceived by the participant. Lower filament values indicate finer tactile discrimination and improved sensory neurological function.

4. Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity(FACT/GOG-NTX)

   Time frame: Baseline (Week 0), Mid-intervention (Week 4), and Post-intervention (Week 8).

   This questionnaire specifically measures the impact of chemotherapy-induced neurotoxicity on a participant's daily functional status. It comprises five subscales: Physical Well-Being (7 items, scored 0-4), Social/Family Well-Being (7 items, scored 0-4), Emotional Well-Being (6 items, scored 0-4), Functional Well-Being (7 items, scored 0-4), and an Additional Concerns/Neurotoxicity subscale (NTX subscale: 11 items assessing numbness, tingling, and dexterity, scored 0-4). Individual items are scored such that higher scores on well-being items and reverse-scored neurotoxicity items represent less symptom distress, reduced neurotoxic impact, and a higher level of daily functional well-being.

5. European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

   Time frame: Baseline (Week 0), Mid-intervention (Week 4), and Post-intervention (Week 8).

   This 30-item instrument evaluates the overall physical, psychological, and social functional status of cancer patients. Items 1-28 are scored on a 4-point scale (1: Not at all, to 4: Very much), and items 29-30 assess global health status and overall quality of life on a 7-point scale (1: Very poor, to 7: Excellent). All scores are linearly transformed to a 0-100 scale according to the EORTC scoring manual. For functional scales and global quality of life, higher scores represent better functioning; for symptom scales (e.g., pain, fatigue, insomnia), higher scores indicate greater symptom severity and distress.

6. World Health Organization Quality of Life-BREF (WHOQOL-BREF)

   Time frame: Baseline (Week 0), Mid-intervention (Week 4), and Post-intervention (Week 8).

   This questionnaire measures the participant's subjective life satisfaction across four comprehensive domains: Physical Health, Psychological, Social Relationships, and Environment. It includes 26 core items scored on a 5-point Likert scale (1 to 5), plus 2 local items assessing respect and food availability (scored 1 to 5). Domain scores are calculated and transformed into a scale ranging from 4 to 20, aligned with the WHOQOL scoring guideline. Higher domain scores indicate a better subjective perception of quality of life and higher satisfaction.