Abstract
Abstract Background Chemotherapy-induced peripheral neuropathy (CIPN) is a frequent side effect of commonly used chemotherapy (CT) regimens and often results in dose reduction or cessation of treatment which can adversely affect cancer outcomes. Treatment options for CIPN are limited and no standard approaches exist to prevent CIPN. A novel therapy, Intraneural Facilitation (INF) has been developed by physical therapists at our institution’s neuropathy treatment center as a preventative and treatment modality for CIPN. INF therapy involves physical maneuvers and systematic application of pressure to improve peripheral microvascular circulation to the endoneurial capillaries of the extremities. We conducted a randomized pilot study evaluating INF versus standard physical therapy (PT) maneuvers as a non-invasive treatment modality for preventing CIPN during participants’ ongoing chemotherapy. This study was supported by an intramural (GRASP) grant and registered on clinicaltrials.gov (NCT0327919). Methods Newly diagnosed patients with breast cancer stages I to III and CT naive gynecologic cancers without preexisting peripheral neuropathy planning to receive treatment with platinum-based compounds and/or taxanes were eligible for this study. Participants were randomized into two treatment groups. Group one received INF and group two received a standardized program of PT including muscle stretching and strengthening exercises. Each group received two (45-minute) treatments twice a week for six weeks under the supervision of trained physical therapists. Participants were evaluated at baseline, week 3, week 6, and 3 months after the date of initiation of chemotherapy. The use of neuropathy medications, CT dose reductions, and treatment discontinuation was compared between the two treatment groups. Vascular perfusion was also evaluated at the same intervals using ultrasound to measure volume flow and pulsatility of the popliteal and posterior tibial arteries. Participants completed a survey at the end of treatment evaluating the effectiveness and satisfaction of the intervention. Results 44 out of 104 patients screened met the eligibility criteria and were randomized to either of the two therapy modalities from July 2017 to June 2022. A total of 38 participants received the allocated intervention and were included in the analysis (n=20 in the INF arm and n=18 in the PT arm). CT dose reduction due to CIPN grade 2 or higher occurred in 6/18 (33%) and 4/20 (20%) participants who received standard PT and INF, respectively. 2/18 (11%) participants required discontinuation of CT prematurely due to CIPN in the standard PT arm when compared to 1/20 (5.0%) in the INF arm. Pharmacologic interventions were required to manage CIPN in 4/18 (22%) participants in the standard PT arm vs 2/20 (10%) in the INF arm at the end of CT. Participants reported more control over their health (95.2% INF arm vs. 83.3% PT arm) and decreased nerve discomfort (75% in the INF arm vs. 61.1% in the PT arm). Participants reported high levels of satisfaction overall at the end of each intervention (95% in the INF arm vs. 83% in the PT arm). Conclusion Our pilot study evaluated the feasibility and potential for INF therapy compared to standard PT for the prevention of CIPN during ongoing chemotherapy. Based on the patient satisfaction survey, the burden and satisfaction with the assigned therapy modality between the two arms were favorable overall. Our results showed that CT dose reduction and early cessation in addition to pharmacologic interventions for CIPN were numerically less prevalent in the INF arm compared to the standard PT arm; however, further studies are needed to validate these findings. Citation Format: Dani Ran Castillo, Won Jin Jeon, Carvy Floyd Luceno, Mark Bussell, Ron Coleman, Karla Pieters, Jamie Hankins, Annette Boggs, Lorena Garcia, Salem Dehom, Ellen D’Errico, Gayathri Nagaraj. A pilot study of novel approach of intraneural facilitation versus standard physical therapy for prevention of chemotherapy induced peripheral neuropathy [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P5-07-14.
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