Purpose/Objective:
Acupuncture is known to reduce various clinical signs and symptoms, for example pain or fatigue. Often patients treated with radiation therapy (RT) suffer from side effects such as fatigue, nausea/vomiting or reduction of quality of life (QOLQoL). Few randomized data is available to define the role of acupuncture in the context of radiation oncology as a supporting treatment. The ROSETTA (RandOmized Study Exploring the combination of radioTherapy with Two types of Acupuncture treatment) is a prospective randomized phase II trial. Ittrial examines if traditional (verum-) acupuncture can reduce radiotherapy (RT)-related side effects significantly in comparison to sham (false-) acupuncture.
Methods:
A total of 74 patients
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They A study investigator will be questionequestions patientsd about their feelings and symptoms as well as on documents detailed information regarding their illness by the investigatorcourse of disease. In the ROSETTA-trial theThe main endpoint is of the trial is improvement of QOL QoL and reduction of fatigue. Secondary endpoints are reduction of RT-related side effects such as headache, nausea, and pain.
Results: The
ROSETTA trial is currently recruiting. Initial results from 30 patients (verum acupuncture n=15; sham acupuncture n=15) are presented. All the following items are scaled from 0 to 100. A high score in a symptom scale represents an aggravation of symptoms. A high score in QoL shows an improvement.
Concerning nausea/vomiting and QOL QoL no there can not be seen asignificant difference can be observed between the sham-acupuncture group and the verum group. Thus, there can be seenpatients suffer from a constant level of these side effects during RT. From the first examination to the last visit, fatigue increases in the group receiving sham acupuncture (from 21 to 44). Meanwhile, fatigue nearly remaines constant in the verum group (from 40 to 40). Verum-acupuncture shows positive effects in reduction of pain (first visit: 21, last visit: 25) in comparison to the sham-acupuncture group (first visit: 23, last visit: