A pilot study of intraneural facilitation versus standard physical therapy for prevention of chemotherapy-induced peripheral neuropathy

JOURNAL OF CLINICAL ONCOLOGY(2023)

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摘要
12068 Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a debilitating side effect necessitating chemotherapy (CT) dose adjustments or early termination. Intraneural Facilitation (INF) is a novel form of manual physical therapy (PT) developed to mitigate CIPN-related symptoms and improve patients’ functional outcome. We conducted a randomized pilot study evaluating the efficacy of INF vs. standard PT in the prevention of CIPN (NCT 03272919). Methods: Eligible participants were patients with newly diagnosed breast cancer (stages I-III) and gynecologic cancer without preexisting peripheral neuropathy planning to receive platinum-based and/or taxane-based CT. Participants were randomly assigned to either INF or PT arm and received two 45-minute treatments twice a week for six weeks during their CT course. Outcomes reported here are a) assessment of pain between the 2 arms using the Pain Quality Assessment Scale (PQAS), and b) measurement of vascular patterns using ultrasound (US), evaluating pulsatility index, volume flow and peak systolic velocity between the 2 arms. Participants were evaluated at baseline, week 3 (W3), week 6 (W6), and month 3 (M3). PQAS scores ranged from 0 to 10 with subscale evaluations of paroxysmal, surface, and deep pain. Pain scores on a scale from 0 to 10 were grouped into none (0), mild (1-3), moderate (4-6) and severe (7-10). The use of neuropathy medications, CT dose reductions, premature CT discontinuation and participant satisfaction surveys between the two groups were previously reported at SABCS 2022. Results: Of 104 screened participants, 44 met the eligibility criteria, with 38 eligible for analysis (n=20 INF arm and n=18 PT arm). Participants reporting moderate or severe pain in either arm were combined (Table). Pain symptoms peaked at W6 coinciding with cumulative CT effects. At M3, none in the INF arm reported moderate or severe paroxysmal pain compared to two participants in the PT arm. One participant in each arm reported moderate or severe surface or deep pain at M3. The US results showed physiologic impact in both arms at W3 and W6, suggesting their role in preserving neural tissue blood flow and reducing vascular damage. Conclusions: Our study shows fewer number of participants on both intervention arms reporting pain, with numerically lower scores on PQAS in INF arm compared to PT arm, especially during ongoing CT. The US results suggest that INF has a unique pathophysiological impact on the microvasculature compared to standard PT; further studies are needed to validate these findings and potentially address their clinical significance as a combined modality. Clinical trial information: NCT03272919 . [Table: see text]
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关键词
peripheral neuropathy,intraneural facilitation,standard physical therapy,chemotherapy-induced
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