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

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ClinicalTrials.gov Identifier: NCT02674646
Recruitment Status : Unknown
Verified February 2016 by Stephanie Combs, Technical University of Munich.
Recruitment status was:  Not yet recruiting
First Posted : February 4, 2016
Last Update Posted : February 4, 2016
Sponsor:
Information provided by (Responsible Party):
Stephanie Combs, Technical University of Munich

Brief 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.

Condition or disease Intervention/treatment Phase
Cancer Radiation: Radiotherapy Device: Needle Acupuncture Phase 2

Detailed 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: RandOmized Study Exploring the Combination of radioTherapy With Two Types of Acupuncture Treatment: The ROSETTA Trial
Study Start Date : February 2016
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: Group A: Verum Acupuncture
Group A: Verum Acupuncture (Needle Acupuncture) Needlepoints Bilateral PC 6, S 36, L 8, L 9 Unilateral R4, R 6 Acupuncture will be applied for approx. 20 min. with 10 needlepoints. Standard radiotherapy
Radiation: Radiotherapy
Radiation as indicated by the cancer diagnosis

Device: Needle Acupuncture
Needle Acupuncture according to Traditional Chinese Medicine (TCM)

Sham Comparator: Group B: Sham Acupuncture
Group B: Sham Acupuncture (Needle Acupuncture) Needlepoints 8 needles in the medioaxillary line below the 6th rib, bilateral 2 needles unilateral Sham-acupuncture will be applied for approx. 20 min. with 10 needlepoints. Standard radiotherapy
Radiation: Radiotherapy
Radiation as indicated by the cancer diagnosis

Device: Needle Acupuncture
Needle Acupuncture according to Traditional Chinese Medicine (TCM)




Primary Outcome Measures :
  1. Quality of Life [ Time Frame: 6 weeks after completion of radiotherapy ]
    questionnaire


Secondary Outcome Measures :
  1. Fatigue [ Time Frame: 6 weeks after radiotherapy ]
    Fatigue measures by questionnaire and fatigue scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Patients meeting all of the following criteria will be considered for admission to the trial:

  • treatment with radiotherapy
  • age ≥ 18 years of age
  • Ability ability of subject to understand character and individual consequences of the clinical trial
  • written informed consent (must be available before enrolment in the trial)

Exclusion Criteria

Patients presenting with any of the following criteria will not be included in the trial:

  • any contraindication to acupuncture
  • known coagulopathy or anticoagulation therapy with bleeding time > 4 minutes, thrombocyte count < 50 000/μl
  • missing compliance
  • skin disease in the region of the acupuncture points
  • refusal of the patients to take part in the study
  • participation in another clinical study or observation period of competing trials,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02674646


Contacts
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Contact: Stephanie E Combs, Prof. Dr. +49-89-4140-4501 stephanie.combs@tum.de
Contact: Rebecca Asadpour +49-89-4140-4501 rebecca.asadpour@tum.de

Sponsors and Collaborators
Technical University of Munich
Investigators
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Principal Investigator: Stephanie E Combs, Prof. Dr. Klinikum rechts der Isar, Radiation Oncology, Professor and Chair
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Stephanie Combs, Univ.-Prof. Dr. med., Professor and Chair, Radiation Oncology, Technical University of Munich
ClinicalTrials.gov Identifier: NCT02674646    
Other Study ID Numbers: ROSETTA
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No