Acupuncture in the treatment of acute toxicity during and after head and neck cancer radiotherapy: Interim analysis of randomized prospective open-label trial

Abstract

The aim of this investigator-initiated prospective randomized open-label single institutional trial is to evaluate the role of acupuncture in the treatment of acute skin and mucosal toxicity, xerostomia, and perception of taste, pain, and nausea related to curative and adjuvant (chemo)radiotherapy of head and neck cancer. This paper reports pilot data of the first 30 enrolled patients. Methods. Patients were randomized to undergo standard of care radiotherapy ± chemotherapy and support care defined by our institutional standard operating procedures alone or in the combination with acupuncture which was initiated with the first signs of any toxicity. Results. Fifteen patients were enrolled in both arms and all finished the treatment as planned.The median pain was significantly lower in the acupuncture arm (median 1.6 points vs. 2.5 points on a 10-item Likert scale; P=0.035) as well as duration of acute pain (median 31 days vs. 54 days; P=0.031). Patients with acupuncture had significantly shorter duration of acute skin (median 44 days vs. 109 days; P<0.001) and mucosal toxicity (median 34 days vs. 109 days; P<0.001) with no difference in grading of toxicity (median grade 1.6 vs. 1.5; P=0.701 and median grade 1.4 vs. 1.6; P=0.204 for skin and mucosa, respectively). No significant difference was found for other toxicity domains, with the exception of salivation toxicity which was significantly lower in acupuncture arm (median grade 1.3 vs. 1.7; P=0.048). Conclusion. In this interim analysis, acupuncture leads to lower pain andfaster disappearance of skin and mucosal toxicity after (chemo)radiotherapy of head and neck cancer. Description and validation of acupuncture using scientific approaches will further enhance acceptance of this method by both patients and health care providers. Trial Registration: Clinicaltrials.gov-NCT03751566

Acupuncture for radiation-induced toxicity in head and neck squamous cell carcinoma: a systematic review based on PICO criteria

“…As demonstrated by our study results, other than xerostomia, very limited data [43,48,[70][71][72] are currently available on the role of acupuncture in respect to other treatmentrelated side effects in HNSCC. In particular, there is little evidence [48] regarding the potential preventive effect on radiation-induced dysphagia.…”

“…Homb et al [42] performed a retrospective analysis of combination acupuncture for xerostomia on 16 patients, thus below the prespecified threshold of 20 subjects upon inclusion in our study. For the same reason, the interimreport [43] on first 15 patients enrolled in a randomized trial assessing the impact of acupuncture on acute toxicity during CRT was also excluded, whereas the publication on the controlled, randomized Rosetta trial [44] had no patient information. Overall, 5 articles published between 2011 and 2019 fulfilled our inclusion criteria and were retained in the final analysis (Table 1).…”

MASCC clinical practice guidelines for the prevention and management of acute radiation dermatitis: part 1) systematic review

“… 145 , 230 , 231 , 232 , 233 , 234 , 235 , 236 , 237 Alternative and multi-component therapies 11 (4) 422 (30; 1–90) Hydrotherapy (1); Acupuncture (1); Mixed emulsion (1); Other (11) Breast (4); Head and neck (1); Multiple (6) Insufficient evidence was reported to support the use of any interventions for ARD management. 179 , 186 , 189 , 200 , 238 , 239 , 240 , 241 , 242 , 243 , 244 “n” indicates the number of studies. RCT, randomized controlled trial; ARD, radiation dermatitis.…”

Methodological Review: Summary of Findings for Acupuncture as Treatment for Cancer Therapy-induced Xerostomia

“…One of these controlled studies was excluded, because it measured dysphagia (9). Additionally, 1 controlled study was included by hand search (10). The study by Braga (2011) As the authors of the study clearly stated ("patients were assigned"), no randomization process took place.…”