Recruiting NCT05762250
Auricular Acupuncture in Patients With Advanced Cancer: a Randomized Clinical Trial.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Auricular Acupuncture.
- Who it may be relevant to
- Registry conditions: Fatigue, Pain, Depression, Advanced Tumour Diseases. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
In the present study, the effect of ear acupressure treatment according to the NADA protocol on the quality of life of patients with advanced tumour diseases. (all stages) will be investigated. Furthermore, the effect of ear acupressure on anxiety and depression, pain, fatigue and sleep of the patients will be assessed.
Interventions
- Other Auricular Acupuncture
Within the NADA protocol, 5 defined points on the patient's ears are treated according to a standardized concept (shen men, kidney, lung, liver, vegetative I).
Primary outcome measures
- Change in disease-specific quality of life (FACT-MM) [Time frame: after 8 weeks (end of intervention)]
Secondary outcome measures (12)
- Change in anxiety and depressiveness [Time frame: fourth week of intervention]
- Change in anxiety and depressiveness [Time frame: after 8 weeks (end of intervention)]
- Change in anxiety and depressiveness [Time frame: 2 weeks post-intervention]
- Change in anxiety and depressiveness [Time frame: 12 weeks post-intervention]
- Change of individual symptom burden [Time frame: fourth week of intervention]
- Change of individual symptom burden [Time frame: after 8 weeks (end of intervention)]
- Change of pain [Time frame: fourth week of intervention]
- Change of pain [Time frame: after 8 weeks (end of intervention)]
- Change of pain [Time frame: 2 weeks post-intervention]
- Change of pain [Time frame: 12 weeks post-intervention]
- Change of Fatigue [Time frame: fourth week of intervention]
- Change of Fatigue [Time frame: after 8 weeks (end of intervention)]
Eligibility criteria
Inclusion criteria
- Adult patients with advanced tumour diseases on current therapy, who suffer from persistent disease- or therapy-associated symptoms and limitations (screening by distress thermometer, score ≥ 5)
- Informed consent.
Exclusion criteria
- medical reasons or
- a mental condition which, in the opinion of the investigator, does not allow the patient to participate in the study,
- a planned radiation therapy in the area of the skull (to avoid potential scattered radiation),
- a missing legally binding signature on the informed consent form,
- participation in another acupuncture/acupressure study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Germany · 2 centers
- Robert Bosch Krankenhaus — Stuttgart
- University Hospital Wuerzburg — Würzburg
Identifiers
NCT: NCT05762250 · S00776