NCT05762250

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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress87%
Aug 2023Oct 2026

First Submitted

Initial submission to the registry

February 22, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 9, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

August 13, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

2.8 years

First QC Date

February 22, 2023

Last Update Submit

July 28, 2025

Conditions

FatiguePainDepressionAdvanced Tumour Diseases

Keywords

Auricular Acupunctureadvanced tumour diseases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (19)

  • Change in anxiety and depressiveness

    fourth week of intervention

  • Change in anxiety and depressiveness

    after 8 weeks (end of intervention)

  • Change in anxiety and depressiveness

    2 weeks post-intervention

  • Change in anxiety and depressiveness

    12 weeks post-intervention

  • Change of individual symptom burden

    fourth week of intervention

  • +14 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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).

Auricular Acupuncture

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Robert Bosch Krankenhaus

Stuttgart, Germany

RECRUITING

University Hospital Wuerzburg

Würzburg, Germany

RECRUITING

MeSH Terms

Conditions

FatiguePainDepression

Interventions

Acupuncture, Ear

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsNeurologic ManifestationsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Acupuncture TherapyComplementary TherapiesTherapeuticsAuriculotherapy

Study Officials

  • Claudia Loeffler, Dr

    University Hospital Wuerzburg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia Loeffler, Dr

CONTACT

+49 93120144966loeffler_C@ukw.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2023

First Posted

March 9, 2023

Study Start

August 13, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

July 31, 2025

Record last verified: 2025-07

Locations

DE(2)