RandOmized Study Exploring the Combination of radioTherapy With Two Types of Acupuncture Treatment: The ROSETTA Trial

Overview

The ROSETTA-trial will evaluate the effect of acupuncture as a complementary treatment parallel to radiation therapy in oncological patients. The trial is designed as a two-armed trial. Depending on the treatment study arm either verum- or Sham sham-acupuncture will be applied. Acupuncture is applied treatment bi-weekly during the first week of radiotherapy, thereafter weekly until the end of radiotherapy; the follow-up visits include clinical workup as well as questionnaires.

Adverse effects such as fatigue, pain, skin problems , nausea and vomiting are commonly known in patients undergoing irradiation alone or in combination with chemotherapy (RCHT). Patients suffering from these symptoms are constricted severely in their daily life and their quality of life (QOL) is often reduced. As examined several times, acupuncture can cause an amelioration of these specific disorders. Especially for pain symptoms several groups have shown efficacy of acupuncture. To what extent a difference between traditional acupuncture (verum-acupuncture) and false acupuncture (sham-acupuncture) can cause reduction of side effects and improvement of QOL is not clarified. Therefore, the ROSETTA trial is a randomized trial with two treatment arms. The verum-group receives "real acupuncture" , while the Sham-group is treated with sham- acupuncture points. These points are "nonsense" needlepoints, which do not have any correlate in TCM. Patients are going to get standardized questionnaires (EORTC QOL C-30) before their first, after their fourth and after their last acupuncture treatment. Patients will be questioned about their condition by the investigator. The answers will be documented according to the standardized scoring system CTCAE (Common Toxicity Criteria for Adverse Events). Group A: Verum Acupuncture Needlepoints Bilateral PC 6, S 36, L 8, L 9 Unilateral R4, R 6 Group B: Sham Acupuncture Needlepoints 8 needles in the medioaxillary line below the 6th rib, bilateral 2 needles unilateral

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Central Contacts