Cancer Clinical Trial - RandOmized Study Exploring the Combination of

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Cancer

Clinical Trial Details

NCT number	NCT02674646
Study type	Interventional
Source	Technische Universität München
Contact	Stephanie E Combs, Prof. Dr.
Phone	+49-89-4140-4501
Email	stephanie.combs@tum.de
Status	Not yet recruiting
Phase	Phase 2
Start date	February 2016
Completion date	February 2018

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms