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NCT Number: NCT05762250

Auricular Acupuncture in Patients With Advanced Cancer: a Randomized Clinical Trial.

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.

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Key information

Conditions

Fatigue Advanced Tumour Diseases Behavior Behavioral Symptoms Depression Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Robert Bosch Krankenhaus, Stuttgart, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Auricular Acupuncture

Other

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 outcomes

  1. Change in disease-specific quality of life (FACT-MM)

    Time frame: after 8 weeks (end of intervention)

    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 outcomes

  1. Change in anxiety and depressiveness

    Time frame: fourth week of intervention

    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. Change in anxiety and depressiveness

    Time frame: after 8 weeks (end of intervention)

    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.

  3. Change in anxiety and depressiveness

    Time frame: 2 weeks post-intervention

    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.

  4. Change in anxiety and depressiveness

    Time frame: 12 weeks post-intervention

    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.

  5. Change of individual symptom burden

    Time frame: fourth week of intervention

    Individual symptom burden - patients are asked to rate their 3 most distressing symptoms on a Numerical Rating Scale.

  6. Change of individual symptom burden

    Time frame: after 8 weeks (end of intervention)

    Individual symptom burden - patients are asked to rate their 3 most distressing symptoms on a Numerical Rating Scale.

  7. Change of pain

    Time frame: fourth week of intervention

    Improvement of pain (FACT-MM) questionnaire

  8. Change of pain

    Time frame: after 8 weeks (end of intervention)

    Improvement of pain (FACT-MM) questionnaire

  9. Change of pain

    Time frame: 2 weeks post-intervention

    Improvement of pain (FACT-MM) questionnaire

  10. Change of pain

    Time frame: 12 weeks post-intervention

    Improvement of pain (FACT-MM) questionnaire

  11. Change of Fatigue

    Time frame: fourth week of intervention

    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. Change of Fatigue

    Time frame: after 8 weeks (end of intervention)

    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.

  13. Change of Fatigue

    Time frame: 2 weeks post-intervention

    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.

  14. Change of Fatigue

    Time frame: 12 weeks post-intervention

    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.

  15. Change of sleep disorders and sleep quality

    Time frame: fourth week of intervention

    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

  16. Change of sleep disorders and sleep quality

    Time frame: after 8 weeks (end of intervention)

    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

  17. Change of sleep disorders and sleep quality

    Time frame: 2 weeks post-intervention

    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

  18. Change of sleep disorders and sleep quality

    Time frame: 12 weeks post-intervention

    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

  19. Number of pateints with adverse events

    Time frame: through study completion, an average of 3 Years

    Tolerability of the application

Study contacts

Contact information is provided by the study sponsor or research team.

Claudia Loeffler, Dr

CONTACT

[email protected]

+49 93120144966

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

  • Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)

Registry information

Acronym: MY_ACU

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 9, 2023
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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