Clinical trial · Interventional
RandOmized Study Exploring the Combination of radioTherapy With Two Types of Acupuncture Treatment: The ROSETTA Trial
NCT02674646CI-TRIAL-00020799ROSETTAunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Needle Acupuncture | Device | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A: Verum Acupuncture
- description
- 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
- interventionNames
- Radiation: Radiotherapy
- Device: Needle Acupuncture
- type
- SHAM_COMPARATOR
- label
- Group B: Sham Acupuncture
- description
- 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
- interventionNames
- Radiation: Radiotherapy
- Device: Needle Acupuncture
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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,
References
Publications (1)
- DERIVEDAsadpour 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. PMID 28851420