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Trial Title:
Auricular Acupuncture in Patients With Multiple Myeloma
NCT ID:
NCT05762250
Condition:
Multiple Myeloma
Fatigue
Pain
Depression
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
Auricular Acupuncture
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
Auricular Acupuncture
Description:
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).
Arm group label:
Auricular Acupuncture
Summary:
In the present study, the effect of ear acupressure treatment according to the NADA
protocol on the quality of life of patients with multiple myeloma (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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Adult patients with multiple myeloma (all stages) 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Robert Bosch Krankenhaus
Address:
City:
Stuttgart
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Marcela Winkler, MD
Facility:
Name:
University Hospital Wuerzburg
Address:
City:
Wuerzburg
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Claudia Loeffler, MD
Start date:
August 13, 2023
Completion date:
October 2026
Lead sponsor:
Agency:
University Hospital Tuebingen
Agency class:
Other
Collaborator:
Agency:
Robert Bosch Hospital Stuttgart
Agency class:
Other
Source:
University Hospital Tuebingen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05762250
