CancerPhase 2ROSETTANCT02674646
RandOmized Study Exploring the Combination of radioTherapy With Two Types of Acupuncture Treatment: The ROSETTA Trial
A Phase 2 study testing Radiotherapy and Needle Acupuncture in people with Cancer, run by Technical University of Munich.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Radiotherapy and Needle Acupuncture
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Feb 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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,
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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
- Conditions
- Cancer
- Being tested
- Radiotherapy, Needle Acupuncture
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Radiation as indicated by the cancer diagnosis
Needle AcupunctureDevice
Needle Acupuncture according to Traditional Chinese Medicine (TCM)
| Study group | Role | What they receive |
|---|---|---|
| Group A: Verum Acupuncture | Experimental | 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 Receives: Radiation: Radiotherapy; Device: Needle Acupuncture |
| Group B: Sham Acupuncture | Sham comparator | 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 Receives: Radiation: Radiotherapy; Device: Needle Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
questionnaire
Measured: 6 weeks after completion of radiotherapy
Secondary outcomes (1)
Fatigue
Fatigue measures by questionnaire and fatigue scale
Measured: 6 weeks after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Combs, Technical University of Munich
- Investigators
- Stephanie E Combs, Prof. Dr., Principal investigator, Klinikum rechts der Isar, Radiation Oncology, Professor and Chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02674646
- Sponsor's protocol ID
- ROSETTA
- Acronym
- ROSETTA
- Status last verified
- Feb 2016
- First submitted
- 8 Dec 2015
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Asadpour R, Kessel KA, Bruckner T, Sertel S, Combs SE. Randomized study exploring the combination of radiotherapy with two types of acupuncture treatment (ROSETTA): study protocol for a randomized controlled trial. Trials. 2017 Aug 29;18(1):398. doi: 10.1186/s13063-017-2139-5.
PubMed 28851420
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RandOmized Study Exploring the Combination of radioTherapy With Two Types of Acupuncture Treatment: The ROSETTA Trial
- ClinicalTrials.gov ID
- NCT02674646
- Acronym / sponsor ID
- ROSETTA / ROSETTA
- Conditions
- Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 4 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Verum Acupuncture | Experimental | Radiation: Radiotherapy, Device: Needle AcupunctureGroup 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 |
| Group B: Sham Acupuncture | Sham comparator | Radiation: Radiotherapy, Device: Needle AcupunctureGroup 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapyRadiation as indicated by the cancer diagnosis | Radiation | Group A: Verum Acupuncture, Group B: Sham Acupuncture |
| Needle AcupunctureNeedle Acupuncture according to Traditional Chinese Medicine (TCM) | Device | Group A: Verum Acupuncture, Group B: Sham Acupuncture |
Primary outcome
Quality of Life
Time frame: 6 weeks after completion of radiotherapy
questionnaire
1 secondary outcome
Fatigue
Time frame: 6 weeks after radiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
- Derived from this study: PubMed 28851420Asadpour R, Kessel KA, Bruckner T, Sertel S, Combs SE. Randomized study exploring the combination of radiotherapy with two types of acupuncture treatment (ROSETTA): study protocol for a randomized controlled trial. Trials. 2017 Aug 29;18(1):398. doi: 10.1186/s13063-017-2139-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie E Combs, Prof. Dr. principal investigator
Klinikum rechts der Isar, Radiation Oncology, Professor and Chair
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiotherapy and Needle Acupuncture in people with Cancer, run by Technical University of Munich.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephanie E Combs, Prof. Dr. (+49-89-4140-4501, stephanie.combs@tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (time frame: 6 weeks after completion of radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02674646, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2016.