A Novel Approach of Intraneural Facilitation Versus Standard Physical Therapy for the Prevention of Chemotherapy-Induced Peripheral Neuropathy: A Randomized Controlled Trial
This study compared Intraneural Facilitation (INF
®
) therapy and standard physical therapy (PT) in preventing chemotherapy-induced peripheral neuropathy (CIPN) in women with newly diagnosed breast and gynecologic cancer. Thirty-eight women undergoing platinum and/or taxane-based chemotherapy, without prior peripheral neuropathy, were randomized into INF
®
therapy (n = 20) and PT (n = 18). Treatments lasted 45 minutes, twice weekly, for 6 weeks. Neuropathy severity was evaluated using the Pain Quality Assessment Scale. Assessments were at baseline, 3 weeks, 6 weeks, and 3 months post-intervention. Acceptability, burden, and satisfaction were evaluated after 6 weeks. Among 38 patients, 12 (32%) experienced CIPN, with mean pain scores remaining mild (≤3) and no pharmacotherapy required until week 6. No adverse events were reported from the interventions. The INF
®
therapy arm showed significant changes in numbness (
F
= 6.030,
P
= .001, partial η
2
= 0.262) after week 6, while the PT arm showed significant changes in numbness (
Z
= −2.39,
P
= .017), tingling (
Z
= −2.84,
P
= .004), cramping (
Z
= −2.120,
P
= .034), surface pain (
Z
= −2.75,
P
= .006), and deep pain (
Z
= −1.99,
P
= .046) between weeks 3 and 6. Nearly 80% of patients completed chemotherapy cycles with an average relative dose intensity of 90.4% (INF
®
therapy: 87.73% vs PT: 73.44%). Ninety-four percent of patients were satisfied with their care, accepted the treatments, and perceived them as a low burden. The results demonstrated that INF
®
therapy and PT are feasible options for CIPN, improving treatment adherence, outcomes, and quality of life for women with newly diagnosed breast and gynecological cancers.
Trial Registration
- The study was pre-registered on ClinicalTrials.gov (NCT03272919). August 8, 2017.
