FatigueMY_ACUNCT05762250
Auricular Acupuncture in Patients With Advanced Cancer: a Randomized Clinical Trial.
A study testing Auricular Acupuncture in people with Fatigue and Pain, run by University Hospital Tuebingen at 2 sites in Germany.
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 advanced tumour diseases. (all stages) will be investigated. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fatigue, Pain, Depression
- What is being tested?
- Auricular Acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 2 sitesGermany
- Study dates
- 13 Aug 2023to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
Robert Bosch Krankenhaus
Stuttgart
Marcela Winkler, MD
- Recruiting
University Hospital Wuerzburg
Würzburg
Claudia Loeffler, MD
About this study
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.
- Conditions
- Fatigue, Pain, Depression, Advanced Tumour Diseases
- Being tested
- Auricular Acupuncture
- Keywords
- Auricular Acupuncture, advanced tumour diseases
- Medical subject headings
- Fatigue, Pain, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular AcupunctureOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Auricular Acupuncture | Experimental | 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. Receives: Other: Auricular Acupuncture |
| Waitlist | No intervention | Control group: standard treatment / waiting list Patients in the control group will also receive a one-time 30-minute psychoeducational interview at baseline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after 8 weeks (end of intervention)
Secondary outcomes (19)
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.
Measured: fourth week of intervention
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.
Measured: after 8 weeks (end of intervention)
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.
Measured: 2 weeks post-intervention
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.
Measured: 12 weeks post-intervention
Change of individual symptom burden
Individual symptom burden - patients are asked to rate their 3 most distressing symptoms on a Numerical Rating Scale.
Measured: fourth week of intervention
Change of individual symptom burden
Individual symptom burden - patients are asked to rate their 3 most distressing symptoms on a Numerical Rating Scale.
Measured: after 8 weeks (end of intervention)
Change of pain
Improvement of pain (FACT-MM) questionnaire
Measured: fourth week of intervention
Change of pain
Improvement of pain (FACT-MM) questionnaire
Measured: after 8 weeks (end of intervention)
Change of pain
Improvement of pain (FACT-MM) questionnaire
Measured: 2 weeks post-intervention
Change of pain
Improvement of pain (FACT-MM) questionnaire
Measured: 12 weeks post-intervention
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.
Measured: fourth week of intervention
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.
Measured: after 8 weeks (end of intervention)
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.
Measured: 2 weeks post-intervention
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.
Measured: 12 weeks post-intervention
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
Measured: fourth week of intervention
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
Measured: after 8 weeks (end of intervention)
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
Measured: 2 weeks post-intervention
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
Measured: 12 weeks post-intervention
Number of pateints with adverse events
Tolerability of the application
Measured: through study completion, an average of 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start13 Aug 2023
- Primary completionJun 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
- Responsible party
- Sponsor
- Investigators
- Claudia Loeffler, Dr, Principal investigator, Wuerzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762250
- Sponsor's protocol ID
- S00776
- Acronym
- MY_ACU
- Status last verified
- Jul 2025
- First submitted
- 22 Feb 2023
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Acupuncture in Patients With Advanced Cancer: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05762250
- Acronym / sponsor ID
- MY_ACU / S00776
- Conditions
- Fatigue, Pain, Depression, Advanced Tumour Diseases
- Keywords
- Auricular Acupuncture, advanced tumour diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
- Study start
- 13 Aug 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auricular Acupuncture | Experimental | Other: Auricular AcupunctureIntervention 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. |
| Waitlist | No intervention | –Control group: standard treatment / waiting list Patients in the control group will also receive a one-time 30-minute psychoeducational interview at baseline. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular AcupunctureWithin 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). | Other | Auricular Acupuncture |
Primary outcome
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.
19 secondary outcomes
Change in anxiety and depressiveness
Time frame: fourth week of intervention
Change in anxiety and depressiveness
Time frame: after 8 weeks (end of intervention)
Change in anxiety and depressiveness
Time frame: 2 weeks post-intervention
Change in anxiety and depressiveness
Time frame: 12 weeks post-intervention
Change of individual symptom burden
Time frame: fourth week of intervention
Change of individual symptom burden
Time frame: after 8 weeks (end of intervention)
Change of pain
Time frame: fourth week of intervention
Change of pain
Time frame: after 8 weeks (end of intervention)
Change of pain
Time frame: 2 weeks post-intervention
Change of pain
Time frame: 12 weeks post-intervention
Change of Fatigue
Time frame: fourth week of intervention
Change of Fatigue
Time frame: after 8 weeks (end of intervention)
Change of Fatigue
Time frame: 2 weeks post-intervention
Change of Fatigue
Time frame: 12 weeks post-intervention
Change of sleep disorders and sleep quality
Time frame: fourth week of intervention
Change of sleep disorders and sleep quality
Time frame: after 8 weeks (end of intervention)
Change of sleep disorders and sleep quality
Time frame: 2 weeks post-intervention
Change of sleep disorders and sleep quality
Time frame: 12 weeks post-intervention
Number of pateints with adverse events
Time frame: through study completion, an average of 3 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claudia Loeffler, Dr principal investigator
Wuerzburg University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular Acupuncture in people with Fatigue and Pain, run by University Hospital Tuebingen at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudia Loeffler, Dr (+49 93120144966, loeffler_C@ukw.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in disease-specific quality of life (FACT-MM) (time frame: after 8 weeks (end of intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.