Clinical trial NCT05762250: Auricular Acupuncture in Patients With Multiple Myeloma
Official title: Auricular Acupuncture in Patients With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Myeloma
Fatigue
Pain
Depression
Keywords: Auricular Acupuncture
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Robert Bosch Gesellschaft für Medizinische Forschung mbH
First posted: 2023-03-09
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Change in disease-specific quality of life (FACT-MM)
timeFrame: after 8 weeks (end of intervention)
Secondary outcomes:
measure: Change in anxiety and depressiveness
timeFrame: fourth week of intervention
measure: Change in anxiety and depressiveness
timeFrame: after 8 weeks (end of intervention)
measure: Change in anxiety and depressiveness
timeFrame: 2 weeks post-intervention
measure: Change in anxiety and depressiveness
timeFrame: 12 weeks post-intervention
measure: Change of individual symptom burden
timeFrame: fourth week of intervention
measure: Change of individual symptom burden
timeFrame: after 8 weeks (end of intervention)
measure: Change of pain
timeFrame: fourth week of intervention
measure: Change of pain
timeFrame: after 8 weeks (end of intervention)
measure: Change of pain
timeFrame: 2 weeks post-intervention
measure: Change of pain
timeFrame: 12 weeks post-intervention
measure: Change of Fatigue
timeFrame: fourth week of intervention
measure: Change of Fatigue
timeFrame: after 8 weeks (end of intervention)
measure: Change of Fatigue
timeFrame: 2 weeks post-intervention
measure: Change of Fatigue
timeFrame: 12 weeks post-intervention
measure: Change of sleep disorders and sleep quality
timeFrame: fourth week of intervention
measure: Change of sleep disorders and sleep quality
timeFrame: after 8 weeks (end of intervention)
measure: Change of sleep disorders and sleep quality
timeFrame: 2 weeks post-intervention
measure: Change of sleep disorders and sleep quality
timeFrame: 12 weeks post-intervention
measure: Number of pateints with adverse events
timeFrame: through study completion, an average of 3 Years
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Robert Bosch Krankenhaus
city: Wuerzburg
country: Germany
facility: University Hospital Wuerzburg
Study officials:
affiliation: University Hospital Wuerzburg
name: Claudia Loeffler, Dr
role: PRINCIPAL_INVESTIGATOR
References: