Clinical trial NCT03874598: Effectiveness of Ear Acupuncture to Improve Insomnia in Women With Breast Cancer
Official title: Effectiveness of Ear Acupuncture to Improve Insomnia in Women With Breast Cancer: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasm
Keywords: Sleep Initiation and Maintenance Disorders
Acupuncture, Ear
Cytokines
Breast Neoplasm
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
Collaborators: name: Karl and Veronica Carstens Foundation
First posted: 2019-03-14
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this clinical study is to investigate the extent to which ear acupuncture has an effect on insomnia in women with breast cancer. It will be investigated whether changes in sleep quality, fatigue, quality of life, stress, and psychological well-being can be achieved. In addition, a proinflammatory cytokine will be meassured.


Eligibility criteria: Inclusion Criteria:

* Histological diagnosed non-metastatic breast CAs (TNM stage I-III)
* Existing insomnia (difficulty falling asleep or sleeping through on at least 3 days per week for at least 3 months) according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM 5).
* willingness to participate in the study (at least 8 out of 10 treatments)
* Signed informed consent

Exclusion Criteria:

* Ongoing or planned chemotherapy, radiation, follow-up treatment or reconstructive plastic surgery during the study period
* Severe physical or psychopharmacologically treated psychiatric comorbidity that prevents a patient from participating in the study
* Pregnancy
* Participation in other clinical trials with behavioural, psychological or complementary medical interventions during the study period
* Regular use of barbiturates, antidepressants or other sleep-inducing drugs, drug abusus, alcoholism

Primary outcomes:
measure: Sleep Quality
timeFrame: week 0
measure: Sleep Quality
timeFrame: week 5
Secondary outcomes:
measure: Quality of Life in cancer patients
timeFrame: week 0
measure: Quality of Life in cancer patients
timeFrame: week 5
measure: Quality of Life in cancer patients
timeFrame: week 17
measure: Quality of Life in cancer patients
timeFrame: week 29
measure: Fatigue
timeFrame: week 0
measure: Fatigue
timeFrame: week 5
measure: Fatigue
timeFrame: week 17
measure: Fatigue
timeFrame: week 29
measure: Psychological well-being
timeFrame: week 0
measure: Psychological well-being
timeFrame: week 5
measure: Psychological well-being
timeFrame: week 17
measure: Psychological well-being
timeFrame: week 29
measure: Stress
timeFrame: week 0
measure: Stress
timeFrame: week 5
measure: Stress
timeFrame: week 17
measure: Stress
timeFrame: week 29
measure: Adverse Events
timeFrame: week 5
measure: Adverse Events
timeFrame: week 17
measure: Change in proinflammatory cytokine
timeFrame: week 0
measure: Change in proinflammatory cytokine
timeFrame: week 5
measure: Expectation
timeFrame: week 0
measure: Sleep Quality
timeFrame: week 17
measure: Sleep Quality
timeFrame: week 29
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Kliniken Essen-Mitte
state: NRW
Study officials:
affiliation: University of Duisburg Essen
name: Gustav Dobos, Prof. MD
role: STUDY_DIRECTOR
References: