Effectiveness of Ear Acupuncture to Improve Insomnia in Women With Breast Cancer

NCT ID: NCT03874598

Last Updated: 2021-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-12
• Study Completion Date: 2020-02-19

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.

Conditions

Breast Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ear acupuncture

Group Type: EXPERIMENTAL

Ear acupuncture

Intervention Type: PROCEDURE

Patients in the intervention group are treated twice a week for five weeks using semi-standardized ear acupuncture.

Psychoeducation

Group Type: ACTIVE_COMPARATOR

Psychoeducation

Intervention Type: BEHAVIORAL

Patients of the control group receive a 1,5 h psychoeducation group concerning sleep improving behaviour.

Interventions

Ear acupuncture

Patients in the intervention group are treated twice a week for five weeks using semi-standardized ear acupuncture.

Intervention Type: PROCEDURE

Psychoeducation

Patients of the control group receive a 1,5 h psychoeducation group concerning sleep improving behaviour.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Karl and Veronica Carstens Foundation

OTHER

Sponsor Role: collaborator

Universität Duisburg-Essen

OTHER

Sponsor Role: lead

Responsible Party

Dr. med. Petra Voiss

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gustav Dobos, Prof. MD

Role: STUDY_DIRECTOR

University of Duisburg Essen

Locations

Kliniken Essen-Mitte

Essen, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

KVC 0/100/2018

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

18-8214-BO

Identifier Type: -

Identifier Source: org_study_id