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

NCT03874598 | Completed

• 2 other identifiers: 18-8214-BOKVC 0/100/2018
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Keywords

Sleep Initiation and Maintenance Disorders; Acupuncture, Ear; Cytokines; Breast Neoplasm

Outcome Measures

Primary Outcomes (2)

• Sleep Quality

  Pittsburgh Sleep Quality Index (PSQI). The PSQI contains 19 self-assessment questions and 5 questions rated by the bed-partner or roommate. The 5 questions rated by the bed-partner or roommate are only used as clinical information and not included in qualitative analysis. The question whether a bed-partner or roommate is present is not included in qualitative analysis as well. The 18 self-assessment items are used to evaluate the sleep quality on 7 domains over the last month (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, and sleep disturbances, use of sleep medication, and daytime dysfunction). Scoring of the answers is based on a scale from 0 to 3, whereby 3 reflects the negative extreme on a Likert Scale. The total score is generated by the summation of the component scores and can vary from 0 to 21, with a higher score corresponding to a reduced sleep quality. A cut-off score of 5 indicates a "poor" sleeper.

  week 0

• Sleep Quality

  Pittsburgh Sleep Quality Index (PSQI). The PSQI contains 19 self-assessment questions and 5 questions rated by the bed-partner or roommate. The 5 questions rated by the bed-partner or roommate are only used as clinical information and not included in qualitative analysis. The question whether a bed-partner or roommate is present is not included in qualitative analysis as well. The 18 self-assessment items are used to evaluate the sleep quality on 7 domains over the last month (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, and sleep disturbances, use of sleep medication, and daytime dysfunction). Scoring of the answers is based on a scale from 0 to 3, whereby 3 reflects the negative extreme on a Likert Scale. The total score is generated by the summation of the component scores and can vary from 0 to 21, with a higher score corresponding to a reduced sleep quality. A cut-off score of 5 indicates a "poor" sleeper.

  week 5

Secondary Outcomes (23)

• Quality of Life in cancer patients

  week 0

• Quality of Life in cancer patients

  week 5

• Quality of Life in cancer patients

  week 17

• Quality of Life in cancer patients

  week 29

• Fatigue

  week 0

Study Arms (2)

Ear acupuncture

EXPERIMENTAL

Procedure: Ear acupuncture

Psychoeducation

ACTIVE COMPARATOR

Behavioral: Psychoeducation

Interventions

Ear acupuncture PROCEDURE

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

Ear acupuncture

Psychoeducation BEHAVIORAL

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

Psychoeducation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universität Duisburg-Essen: lead
• Karl and Veronica Carstens Foundation: collaborator

Study Sites (1)

Kliniken Essen-Mitte

Essen, North Rhine-Westphalia, 45276, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms; Sleep Initiation and Maintenance Disorders

Interventions

Acupuncture, Ear

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy

Study Officials

• Gustav Dobos, Prof. MD

  University of Duisburg Essen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 14, 2019
• Study Start: June 12, 2019
• Primary Completion: February 19, 2020
• Study Completion: February 19, 2020
• Last Updated: May 24, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)