Acupuncture and acupressure to mitigate chemotherapy-induced peripheral neuropathy for GI cancer patients receiving oxaliplatin-based regimens: A pilot and feasibility study.

Abstract

113 Background: Chemotherapy-induced peripheral neuropathy (CIPN) from oxaliplatin significantly affects quality of life and is a common cause of dose reductions for gastrointestinal (GI) cancer chemotherapy regimens. We sought to investigate whether the addition of acupuncture and acupressure to standard-of-care (SOC) cryotherapy would further reduce CIPN symptoms and decrease chemotherapy dose reductions. Methods: Eligible patients had any stage GI cancer for which a 5-fluorouracil (5-FU)/oxaliplatin-based regimen was recommended. Additional chemotherapy (e.g. irinotecan) or targeted therapies (e.g. bevacizumab, cetuximab, trastuzumab) were permitted, provided the regimen was given every 2 weeks with standard oxaliplatin dosing (85mg/m 2 ). Study participants were randomized 1:1 to 3 months of a standardized acupuncture protocol (delivered on day 1 and 3 of each cycle) plus twice daily acupressure (instructed to perform at home) plus SOC cryotherapy (oral ice chips and hand/feet ice packs during oxaliplatin infusion) (A/A arm) or SOC cryotherapy alone (SOC arm). The primary endpoint was change in CIPN severity as measured by the EORTC-CIPN-20 questionnaire from baseline to 3 months. Key secondary endpoints included CIPN by CTCAE and intervention adherence. Differences in normalized change in EORTC-CIPN-20 between arms were assessed by marginal modeling, regression, and permutation tests. Results: 69/93 enrolled participants were randomized and evaluable for the primary endpoint: 33 to A/A (48%) and 36 to SOC. Reasons for non-evaluability were failed screening (n=15) and lack of endpoint data (n=9). Demographics and cancer characteristics were similar between arms (overall 51% women, 74% White, median age 55 years; 51% colorectal, 16% pancreas, 15% gastroesophageal; 61% FOLFOX, 39% FOLFIRINOX). Per protocol adherence to the A/A intervention was 70%, largely due to limited acupuncture staff availability and intervention refusal. 3-month CIPN-related symptoms in A/A vs SOC were less severe (but not statistically significantly different): sensory (+5.9 vs +9.1 points; p=0.25), motor (+1.9 vs +5.7 points; p=0.07), and autonomic (+0.56 vs +0.82 point; p=0.96). By investigator-assessed CTCAE, 15% of A/A vs. 8% of SOC patients had grade 2+ CIPN during the 3 months. Mean oxaliplatin dose density and oral cryotherapy dose density were similar between arms (81.5% A/A vs 80.9% SOC) and (40.9% A/A vs 44.1% SOC), respectively. Conclusions: In this pilot study, the addition of acupuncture and acupressure to SOC cryotherapy slightly decreased CIPN incidence and severity in GI cancer patients receiving oxaliplatin-based chemotherapy, although symptoms were not significantly improved relative to SOC treatment. Clinical trial information: NCT04505553 .