S301
Clinical - Breast
ESTRO 2026
verum acupuncture led to a significant reduction in headache (CTCAE; visit 1:p = 0.021; visit 6: p = 0.049) compared with sham treatment. There was also a trend toward fewer skin reactions (CTCAE, p = 0.054) and improved role functioning (QLQ-C30, p = 0.058).The remaining scales showed no clinically relevant advantage of verum acupuncture during radiotherapy.
Proffered Paper 3350 The ROSETTA Trial: A Randomized, Sham- Controlled Study suggests Reduced Fatigue and Improved Well-Being in Breast Cancer Patients (NCT02674646) Aleyna Yilap 1 , Rebecca Moser 1 , Katharina Sommer 2 , Lena M. Buchecker 1 , Jana Nano 1 , Sophie T. Behzadi 1 , Sophia Kiesl 1 , Luisa Allwohn 1 , Sophie Maier 1 , Kai J. Borm* 1 , Stephanie E. Combs* 1,3 1 Department of Radiation Oncology, Klinikum Rechts der Isar, Technical University of Munich (TUM), Munich, Germany. 2 Department of Radiation Oncology, Klinikum Bamberg, Sozialstiftung Bamberg, Bamberg, Germany. 3 Department of Radiation Sciences (DRS), Institute of Innovative Radiotherapy (iRT), Helmholtz Zentrum, Munich, Germany Purpose/Objective: This study investigates the effectiveness of adjunctive acupuncture during radiotherapy, focusing on fatigue and quality of life (QoL). Further endpoints include pain, nausea and emesis, insomnia, and loss of appetite. Material/Methods: In the ROSETTA trial, 60 radiotherapy patients were recruited between 2010–2016 and randomly assigned to verum or sham acupuncture. Verum acupuncture, based on the principles of Traditional Chinese Medicine (TCM), was applied at traditional acupoints, while sham treatment used non-specific, TCM- irrelevant locations. Acupuncture was performed concurrently with radiotherapy using standardized needles—twice weekly in the first week and once weekly thereafter, for up to seven weeks (eight sessions). Quality of life and fatigue were assessed with the EORTC QLQ-C30; fatigue was additionally evaluated using CTCAE. QLQ-C30 was collected at five time points: before the first, after the fourth and final acupuncture sessions, six weeks post-radiotherapy, and at late follow-up (March/April 2025). CTCAE and Karnofsky Index were recorded at baseline and each session. During follow-up, a questionnaire assessed the long-lasting perceived benefit of acupuncture. The current study represents a subgroup analysis of primary breast cancer patients. Results: In the subgroup of 43 breast cancer patients, there was a trend toward improved fatigue in the verum group at the end of treatment (visit 5; CTCAE, p = 0,0645).Although no measurable improvement in QoL was detected in standardized EORTC questionnaires, patients in the verum group reported higher satisfaction and a more positive perception of verum acupuncture, described as pleasant, beneficial, and enhancing well-being based on study specific questionnaires. Among the secondary endpoints,
Conclusion: The randomized trial indicates that verum
acupuncture may help to decrease fatigue and improve satisfaction during postoperative breast radiotherapy. Its high acceptance highlights its potential as a feasible, supportive, and well-tolerated complementary treatment during radiotherapy.*shared last authorship. References: 1. Asadpour R, Kessel K, Bruckner T, et al. The ROSETTA trial: design of a randomized phase II study on acupuncture during radiotherapy [dissertation]. Munich: Technical University of Munich; 2017.2. Fayers PM, Aaronson NK, Bjordal K, et al. EORTC QLQ-C30 Scoring Manual. 3rd ed. Brussels: European Organisation for Research and Treatment of Cancer; 2001. Keywords: Radiation therapy, Acupuncture, Fatigue
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