Actively Recruiting
Auricular Acupuncture in Patients With Advanced Cancer: a Randomized Clinical Trial.
Led by University Hospital Tuebingen · Updated on 2025-07-31
125
Participants Needed
2
Research Sites
17 weeks
Total Duration
On this page
Sponsors
U
University Hospital Tuebingen
Lead Sponsor
R
Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of ear acupressure treatment following the NADA protocol on quality of life in patients with advanced tumor diseases at all stages. The study focuses on how this treatment may impact anxiety, depression, pain, fatigue, and sleep in these patients. The trial is randomized and single-blinded, aiming to better understand symptom management during ongoing cancer therapy. Participants are randomly assigned to one of two groups. The intervention group receives ear acupressure on both ears using permanent pellets applied once a week at the study center for 8 weeks. These pellets remain on the ears for 5 days and patients are instructed to massage them three times daily. Additionally, these patients receive a 30-minute psychoeducational talk at the first treatment visit to support their health skills. The control group receives standard treatment and a one-time 30-minute psychoeducational interview at baseline. During the study, participants are assessed for changes in disease-specific quality of life after 8 weeks of intervention. Secondary measures include changes in anxiety, depression, symptom burden, pain, fatigue, and sleep quality at multiple time points during and after treatment, including 2 and 12 weeks post-intervention. Safety is monitored by tracking adverse events over an average of 3 years. The total participation spans at least 8 weeks of active treatment, with follow-up assessments continuing thereafter.
CONDITIONS
Brief Title
Auricular Acupuncture in Patients With Advanced Cancer: a Randomized Clinical Trial.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients with advanced tumour diseases on current therapy who have persistent disease- or therapy-associated symptoms and limitations (distress thermometer score 25 5)
- Able and willing to provide informed consent
You will not qualify if you...
- Medical reasons or mental conditions that prevent participation as judged by the investigator
- Planned radiation therapy in the skull area
- Missing legally binding informed consent
- Participation in another acupuncture or acupressure study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 8 weeks
Participants receive auricular acupuncture according to the NADA protocol over 8 weeks. They attend the study center once per week for application of acupressure patches, which remain on both ears for 5 days and should be massaged three times daily by the participants themselves. A 30-minute psychoeducational talk is given at the first treatment appointment.
Weekly visits for 8 weeks
Duration - Up to 3 years
Participants are assessed for changes in anxiety, depressiveness, symptom burden, pain, fatigue, and sleep quality at 2 weeks and 12 weeks after the end of the intervention. Adverse events are monitored through study completion, averaging 3 years.
Visits at 2 weeks and 12 weeks post-intervention
Trial Site Locations
Total: 2 locations
1
Robert Bosch Krankenhaus
Stuttgart, Germany
Actively Recruiting
2
University Hospital Wuerzburg
Würzburg, Germany
Actively Recruiting
Research Team
C
Claudia Loeffler, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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