Auricular Acupuncture in Patients With Multiple Myeloma

Depression Clinical Trial

— MY_ACU  

Official title:

Auricular Acupuncture in Patients With Multiple Myeloma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05762250
• Other study ID #: S00776
• Status: Recruiting
• Phase: N/A
• Start date: August 13, 2023
• Est. completion date: October 2026

Study information

• Verified date: November 2023
• Source: University Hospital Tuebingen
• Contact: Claudia Loeffler, Dr
• Phone: +49 93120144966
• Email: loeffler_C[@]ukw.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: October 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Fatigue
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Pain

Intervention

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).

Locations

Country	Name	City	State
Germany	Robert Bosch Krankenhaus	Stuttgart
Germany	University Hospital Wuerzburg	Wuerzburg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Robert Bosch Hospital Stuttgart

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in disease-specific quality of life (FACT-MM)	The FACT-MM can depict a more comprehensive picture of the patient's health status and collects data on precisely those areas that are most important to the patient himself.; The diagnosis-specific subscale developed in this process assesses pain, fatigue, physical activity, emotional health, and cognitive abilities and represents the primary outcome parameter in this study.	after 8 weeks (end of intervention)
Secondary	Change in anxiety and depressiveness	The four-item PHQ-4 is part of the PHQ-D, a health questionnaire for patients, and is composed of the PHQ-2, a two-item depression scale, and the GAD-2, a two-item anxiety scale.	fourth week of intervention
Secondary	Change in anxiety and depressiveness	The four-item PHQ-4 is part of the PHQ-D, a health questionnaire for patients, and is composed of the PHQ-2, a two-item depression scale, and the GAD-2, a two-item anxiety scale.	after 8 weeks (end of intervention)
Secondary	Change in anxiety and depressiveness	The four-item PHQ-4 is part of the PHQ-D, a health questionnaire for patients, and is composed of the PHQ-2, a two-item depression scale, and the GAD-2, a two-item anxiety scale.	2 weeks post-intervention
Secondary	Change in anxiety and depressiveness	The four-item PHQ-4 is part of the PHQ-D, a health questionnaire for patients, and is composed of the PHQ-2, a two-item depression scale, and the GAD-2, a two-item anxiety scale.	12 weeks post-intervention
Secondary	Change of individual symptom burden	Individual symptom burden - patients are asked to rate their 3 most distressing symptoms on a Numerical Rating Scale.	fourth week of intervention
Secondary	Change of individual symptom burden	Individual symptom burden - patients are asked to rate their 3 most distressing symptoms on a Numerical Rating Scale.	after 8 weeks (end of intervention)
Secondary	Change of pain	Improvement of pain (FACT-MM) questionnaire	fourth week of intervention
Secondary	Change of pain	Improvement of pain (FACT-MM) questionnaire	after 8 weeks (end of intervention)
Secondary	Change of pain	Improvement of pain (FACT-MM) questionnaire	2 weeks post-intervention
Secondary	Change of pain	Improvement of pain (FACT-MM) questionnaire	12 weeks post-intervention
Secondary	Change of Fatigue	The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a 13-item questionnaire designed to assess self-reported fatigue and its impact on daily activities and functions.	fourth week of intervention
Secondary	Change of Fatigue	The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a 13-item questionnaire designed to assess self-reported fatigue and its impact on daily activities and functions.	after 8 weeks (end of intervention)
Secondary	Change of Fatigue	The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a 13-item questionnaire designed to assess self-reported fatigue and its impact on daily activities and functions.	2 weeks post-intervention
Secondary	Change of Fatigue	The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a 13-item questionnaire designed to assess self-reported fatigue and its impact on daily activities and functions.	12 weeks post-intervention
Secondary	Change of sleep disorders and sleep quality	The Pittsburgh Sleep Quality Index (PSQI) was developed as a standardized self-assessment questionnaire by the University of Pittsburgh to elicit quality of sleep using qualitative and quantitative questions at a 4-week interval	fourth week of intervention
Secondary	Change of sleep disorders and sleep quality	The Pittsburgh Sleep Quality Index (PSQI) was developed as a standardized self-assessment questionnaire by the University of Pittsburgh to elicit quality of sleep using qualitative and quantitative questions at a 4-week interval	after 8 weeks (end of intervention)
Secondary	Change of sleep disorders and sleep quality	The Pittsburgh Sleep Quality Index (PSQI) was developed as a standardized self-assessment questionnaire by the University of Pittsburgh to elicit quality of sleep using qualitative and quantitative questions at a 4-week interval	2 weeks post-intervention
Secondary	Change of sleep disorders and sleep quality	The Pittsburgh Sleep Quality Index (PSQI) was developed as a standardized self-assessment questionnaire by the University of Pittsburgh to elicit quality of sleep using qualitative and quantitative questions at a 4-week interval	12 weeks post-intervention
Secondary	Number of pateints with adverse events	Tolerability of the application	through study completion, an average of 3 Years