145 - Acupuncture for (Chemo)Radiotherapy - Related Dysphagia in Patients with Head and Neck Squamous Cell Carcinoma (HNSCC): A Randomized Phase 2 Study

P. Bonomo¹, I. Morelli¹, S. Caini², M. Ganovelli¹, B. Bettazzi¹, F. De Felice³, C. G. Cattaneo³, C. Iotti⁴, M. P. Ruggieri⁴, G. Cristina⁵, J. M. Waskiewicz⁶, C. M. Bona⁷, C. Capitanio⁸, A. Malorgio⁹, S. Princivalle⁹, C. Becherini¹, I. Desideri¹⁰, V. Salvestrini¹, L. Livi¹⁰, and C. Guido¹¹; ¹Radiation Oncology, Careggi University Hospital, University of Florence, Florence, Italy, ²Institute for Cancer Research, Prevention, and Clinical Network (ISPRO), Florence, Italy, ³Radiation Oncology, Policlinico Umberto I, Department of Radiological, Oncological and Pathological Sciences, "Sapienza" University of Rome, Rome, Italy, ⁴Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy, ⁵Medicina Complementare, Ospedale Franz Tappeiner, Azienda Sanitaria dell’Alto Adige, Bolzano, Italy, ⁶Servizio di Radioterapia Oncologica, Azienda Sanitaria dell’ Alto Adige, Bolzano, Italy, ⁷SOS Radioterapia ASL VCO, Verbania, Italy, ⁸Centro Ortopedico di Quadrante COQ Omegna, Verbania, Italy, ⁹Radioterapia Oncologica, Azienda Ospedaliero Universitaria di Ferrara, Ferrara, Italy, ¹⁰Department of Experimental Clinical and Biomedical Sciences “Mario Serio”, University of Florence, Florence, Italy, ¹¹Centro Fior di Prugna, Struttura regionale di riferimento per le MC e la MTC, SOS Centro di Coordinamento Aziendale di Medicina complementare, Azienda USL Toscana Centro, Presidio Camerata, Florence, Italy

Purpose/Objective(s): For patients with HNSCC, there is an unmet need to limit the subjective burden of dysphagia (DYS) during (chemo)radiotherapy (CRT) to prevent the occurrence of severe malnutrition. Acupuncture (ACP) is a traditional Chinese medicine technique with growing indication for symptom management in oncology. We designed a multicenter randomized, phase II trial (NCT05143268) to test the hypothesis that ACP may mitigate patient-reported DYS in patients undergoing curatively-intended CRT for HNSCC. Materials/

Methods: Patients diagnosed with HNSCC of the oropharynx, larynx, hypopharynx and nasopharynx suitable for CRT were 1:1 randomized to an experimental (A) or standard (B) arm. In arm A, 11 weekly sessions of ACP were performed by a board-certified acupuncturist, spanning from 2 weeks before CRT to 2 weeks after its completion. In arm B, patients received standard supportive care. Parotid- and swallowing-sparing IMRT was mandatory in both arms. Patients were stratified according to uni vs bilateral neck irradiation and delivery of concurrent vs no systemic therapy. EORTC QLQ-C30, QLQ-HN43 and MDADI questionnaires were collected at baseline and 2, 12 and 24 weeks after CRT. Adverse events were assessed with CTCAE v.5.0. The primary endpoint of the study was the severity of acute DYS 2 weeks after CRT according to MDADI composite score. Assuming a mean MDADI composite score of 58, based on the results of the De-ESCALaTE randomized phase 3 trial, the use of ACP was hypothesized to yield a >10 point difference compared with arm B. Assuming a standard deviation (SD) of 18 in both arms, with a=0.05 and 0.80 power, a total of 90 patients were required (accounting for 10% drop-out).
Results: From 06/21 to 11/23, 91 patients (Arm A, 44; arm B, 47) were enrolled from 6 centers, with a median age of 69 years (48-84). The majority had a primary tumor of the oropharynx (77%), of whom 72.8% were HPV positive, and received cisplatin-based CRT (76%). Bilateral neck irradiation was delivered in 89% of cases. In arm A, compliance to ACP was satisfactory, with 68% of patients undergoing >75% of ACP sessions No ACP-related side effects were reported. Moderate-severe DYS (>G2) was not different between the two arms (53% vs 47%, respectively; p<.87). In respect to the primary endpoint, no difference was observed 2 weeks after CRT between the two arms (mean MDADI composite score of 72.1, SD 17.2, and 67.4, SD 20.7, in arms A and B, respectively). A higher proportion of MDADI global score of 4-5 was observed in arm A (56.4%) compared with arm B (29.7%; p=0.023). Over time, patient-reported change in severity of QLQ-HN43 domains such as dry mouth, social eating and swallowing favored arm A vs arm B (p=0.091, 0.002 and 0.052, respectively).
Conclusion: The results of our study suggest that ACP may safely contribute to mitigate patient-reported swallowing dysfunction during CRT. Further studies are needed to confirm the clinical relevance and generalizability of our findings.