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Auricular Acupuncture in Patients With Multiple Myeloma (MY_ACU)

Primary Purpose

Multiple Myeloma, Fatigue, Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Auricular Acupuncture
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Auricular Acupuncture

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Auricular Acupuncture

    Waitlist

    Arm Description

    Intervention group: Ear acupressure is performed on both ears with permanent pellets according to the NADA (National Acupuncture Detoxification Association) protocol over a period of 8 weeks (presentation at the study center 1x/week, application of the acupressure patches there; these remain on both ears for 5 days and should be massaged 3x/day by the patients themselves according to the instructions provided). In addition, patients receive a 30-minute psychoeducational talk at the first treatment appointment to promote their own health competence.

    Control group: standard treatment / waiting list Patients in the control group will also receive a one-time 30-minute psychoeducational interview at baseline.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    Change of individual symptom burden
    Individual symptom burden - patients are asked to rate their 3 most distressing symptoms on a Numerical Rating Scale.
    Change of individual symptom burden
    Individual symptom burden - patients are asked to rate their 3 most distressing symptoms on a Numerical Rating Scale.
    Change of pain
    Improvement of pain (FACT-MM) questionnaire
    Change of pain
    Improvement of pain (FACT-MM) questionnaire
    Change of pain
    Improvement of pain (FACT-MM) questionnaire
    Change of pain
    Improvement of pain (FACT-MM) questionnaire
    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.
    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.
    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.
    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.
    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
    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
    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
    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
    Number of pateints with adverse events
    Tolerability of the application

    Full Information

    First Posted
    February 22, 2023
    Last Updated
    October 6, 2023
    Sponsor
    University Hospital Tuebingen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05762250
    Brief Title
    Auricular Acupuncture in Patients With Multiple Myeloma
    Acronym
    MY_ACU
    Official Title
    Auricular Acupuncture in Patients With Multiple Myeloma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    June 2026 (Anticipated)
    Study Completion Date
    October 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital Tuebingen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Myeloma, Fatigue, Pain, Depression
    Keywords
    Auricular Acupuncture

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    125 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Auricular Acupuncture
    Arm Type
    Experimental
    Arm Description
    Intervention group: Ear acupressure is performed on both ears with permanent pellets according to the NADA (National Acupuncture Detoxification Association) protocol over a period of 8 weeks (presentation at the study center 1x/week, application of the acupressure patches there; these remain on both ears for 5 days and should be massaged 3x/day by the patients themselves according to the instructions provided). In addition, patients receive a 30-minute psychoeducational talk at the first treatment appointment to promote their own health competence.
    Arm Title
    Waitlist
    Arm Type
    No Intervention
    Arm Description
    Control group: standard treatment / waiting list Patients in the control group will also receive a one-time 30-minute psychoeducational interview at baseline.
    Intervention Type
    Other
    Intervention Name(s)
    Auricular Acupuncture
    Intervention 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).
    Primary Outcome Measure Information:
    Title
    Change in disease-specific quality of life (FACT-MM)
    Description
    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.
    Time Frame
    after 8 weeks (end of intervention)
    Secondary Outcome Measure Information:
    Title
    Change in anxiety and depressiveness
    Description
    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.
    Time Frame
    fourth week of intervention
    Title
    Change in anxiety and depressiveness
    Description
    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.
    Time Frame
    after 8 weeks (end of intervention)
    Title
    Change in anxiety and depressiveness
    Description
    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.
    Time Frame
    2 weeks post-intervention
    Title
    Change in anxiety and depressiveness
    Description
    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.
    Time Frame
    12 weeks post-intervention
    Title
    Change of individual symptom burden
    Description
    Individual symptom burden - patients are asked to rate their 3 most distressing symptoms on a Numerical Rating Scale.
    Time Frame
    fourth week of intervention
    Title
    Change of individual symptom burden
    Description
    Individual symptom burden - patients are asked to rate their 3 most distressing symptoms on a Numerical Rating Scale.
    Time Frame
    after 8 weeks (end of intervention)
    Title
    Change of pain
    Description
    Improvement of pain (FACT-MM) questionnaire
    Time Frame
    fourth week of intervention
    Title
    Change of pain
    Description
    Improvement of pain (FACT-MM) questionnaire
    Time Frame
    after 8 weeks (end of intervention)
    Title
    Change of pain
    Description
    Improvement of pain (FACT-MM) questionnaire
    Time Frame
    2 weeks post-intervention
    Title
    Change of pain
    Description
    Improvement of pain (FACT-MM) questionnaire
    Time Frame
    12 weeks post-intervention
    Title
    Change of Fatigue
    Description
    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.
    Time Frame
    fourth week of intervention
    Title
    Change of Fatigue
    Description
    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.
    Time Frame
    after 8 weeks (end of intervention)
    Title
    Change of Fatigue
    Description
    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.
    Time Frame
    2 weeks post-intervention
    Title
    Change of Fatigue
    Description
    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.
    Time Frame
    12 weeks post-intervention
    Title
    Change of sleep disorders and sleep quality
    Description
    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
    Time Frame
    fourth week of intervention
    Title
    Change of sleep disorders and sleep quality
    Description
    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
    Time Frame
    after 8 weeks (end of intervention)
    Title
    Change of sleep disorders and sleep quality
    Description
    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
    Time Frame
    2 weeks post-intervention
    Title
    Change of sleep disorders and sleep quality
    Description
    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
    Time Frame
    12 weeks post-intervention
    Title
    Number of pateints with adverse events
    Description
    Tolerability of the application
    Time Frame
    through study completion, an average of 3 Years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Claudia Loeffler, Dr
    Phone
    +49 93120144966
    Email
    loeffler_C@ukw.de
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Claudia Loeffler, Dr
    Organizational Affiliation
    University Hospital Wuerzburg
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Auricular Acupuncture in Patients With Multiple Myeloma

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