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Preoperative Relaxation Training and Acupuncture to Minimize Perioperative Symptoms in Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02276404
Recruitment Status : Completed
First Posted : October 28, 2014
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Silke Lange, Universität Duisburg-Essen

Brief Summary:
Breast cancer surgery is associated with presurgical psychological distress and clinically significant side effects including postsurgical pain, nausea and fatigue. A few studies have examined how to intervene to assist women undergoing breast cancer surgery. For example presurgical hypnosis has been proven to decrease side effects and even intraoperative anesthesia use. Besides the more psychologically based interventions there are a few studies suggesting positive effects of acupuncture on pain, anxiety and nausea in surgery patients.This study aims to investigate whether a presurgical relaxation training, acupuncture treatment or a combination of both therapies is able to reduce presurgical psychological distress an postsurgical side effects in breast cancer patients in comparison to usual care.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Behavioral: relaxation training Other: acupuncture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Entspannung Und Akupunktur Zur Reduktion Perioperativer Symptome Bei Brustkrebspatientinnen- Eine Randomisiert-kontrollierte Interventionsstudie im Kontext Einer Integrativ Onkologischen Versorgung (EARpeS)
Actual Study Start Date : November 2014
Actual Primary Completion Date : November 2018
Actual Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: relaxation training
Each participant of the experimental group 1 receives 2 one-hour sessions of guided relaxation training prior to surgery.
Behavioral: relaxation training
The relaxation sessions comprise an introduction in 3 relaxation techniques conducted by a mind-body therapist: "Body Scan", mindfulness meditation and imagination. Patients also receive a CD with different relaxation exercises and the instruction to exercise daily at home for at least 15 minutes.

Experimental: acupuncture
Each participant of the experimental group 2 receives 3 acupuncture treatments with a semi-standardized acupoint scheme: once a week over 2 weeks and the day before surgery.
Other: acupuncture
The acupuncture treatment comprises needling of 6 standardized acupoints: Pericardium 6, Stomach 36, Large intestine 4, Spleen/Pancreas 10, Dumai 20, Liver 3, Shenmen. Additional points can be chosen individual.

Experimental: relaxation training and acupuncture
Each patient of the experimental group 3 receives 3 acupuncture treatments with a semi-standardized acupoint scheme and 2 one-hour sessions of guided relaxation training prior to surgery.
Behavioral: relaxation training
The relaxation sessions comprise an introduction in 3 relaxation techniques conducted by a mind-body therapist: "Body Scan", mindfulness meditation and imagination. Patients also receive a CD with different relaxation exercises and the instruction to exercise daily at home for at least 15 minutes.

Other: acupuncture
The acupuncture treatment comprises needling of 6 standardized acupoints: Pericardium 6, Stomach 36, Large intestine 4, Spleen/Pancreas 10, Dumai 20, Liver 3, Shenmen. Additional points can be chosen individual.

No Intervention: usual care
Patients receive usual senological treatment



Primary Outcome Measures :
  1. presurgical psychological distress [ Time Frame: expected average of 13 days ]
    Measured by 100mm visual analog scale 1 day pre surgery

  2. postsurgical pain [ Time Frame: expected average of 15 days ]
    Measured by 100mm visual analog scale 1 day post surgery


Secondary Outcome Measures :
  1. postsurgical psychological distress [ Time Frame: expected average of 15 days ]
    Measured by 100mm visual analog scale 1 day post surgery

  2. postsurgical psychological distress [ Time Frame: expected average of 21 days ]
    Measured by 100mm visual analog scale 1 week post surgery

  3. postsurgical pain [ Time Frame: expected average of 21 days ]
    Measured by 100mm visual analog scale 1 week post surgery

  4. postsurgical nausea [ Time Frame: expected average of 15 days ]
    Measured by 100mm visual analog scale 1 day post surgery

  5. postsurgical nausea [ Time Frame: expected average of 21 days ]
    Measured by 100mm visual analog scale 1 week post surgery

  6. postsurgical fatigue [ Time Frame: expected average of 15 days ]
    Measured by 100mm visual analog scale 1 day post surgery

  7. postsurgical fatigue [ Time Frame: expected average of 21 days ]
    Measured by 100mm visual analog scale 1 week post surgery

  8. intraoperative analgesia use [ Time Frame: expected average of 14 days ]
    intraoperative analgesia use is taken from operative logs

  9. intraoperative anesthesia use [ Time Frame: expected average of 14 days ]
    intraoperative anesthesia use is taken from operative logs

  10. postoperative analgesia use [ Time Frame: expected average of 15 days ]
    postoperative analgesia use is taken from medical records

  11. immunemodulation [ Time Frame: expected average of 14 days ]
    natural killer cell activity is measured at begin of surgery

  12. immunemodulation [ Time Frame: expected average of 14 days ]
    natural killer cell activity is measured at end of surgery

  13. Number of patients with adverse events [ Time Frame: expected average of 21 days ]
    Number of patients with adverse events are measured one week post surgery

  14. presurgical psychological distress [ Time Frame: expected average of 13 days ]
    Measured by Profile of Mood States (POMS) 1 day pre surgery

  15. postsurgical psychological distress [ Time Frame: expected average of 15 days ]
    Measured by Profile of Mood States (POMS) 1 day post surgery

  16. postsurgical psychological distress [ Time Frame: expected average of 21 days ]
    Measured by Profile of Mood States (POMS) 1 week post surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • clinically proven breast cancer with an indication for breast conserving surgery with max. 50% volume reduction
  • physical and psychological ability to take part in relaxation training

Exclusion criteria:

  • serious psychiatric disorder
  • to time span to surgery shorter than 2 weeks or longer than 20 weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02276404


Locations
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Germany
Department of Senology, Kliniken Essen-Mitte
Essen, Germany, 45136
Sponsors and Collaborators
Universität Duisburg-Essen
Investigators
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Study Chair: Gustav J. Dobos, Prof Chair of Complementary and Integrative Medicine, Universitay of Duisburg-Essen, Germany
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Responsible Party: Silke Lange, Research fellow, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT02276404    
Other Study ID Numbers: 14-5778-BO
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases