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

Cancer Clinical Trial

— ROSETTA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02674646
• Other study ID #: ROSETTA
• Status: Not yet recruiting
• Phase: Phase 2
• First received: December 8, 2015
• Last updated: February 3, 2016
• Start date: February 2016
• Est. completion date: February 2018

Study information

• Verified date: February 2016
• Source: Technische Universität München
• Contact: Stephanie E Combs, Prof. Dr.
• Phone: +49-89-4140-4501
• Email: stephanie.combs[@]tum.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 74
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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,

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

Intervention

Radiation:
• Radiotherapy
Radiation as indicated by the cancer diagnosis

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life	questionnaire	6 weeks after completion of radiotherapy	No
Secondary	Fatigue	Fatigue measures by questionnaire and fatigue scale	6 weeks after radiotherapy	No