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Completed

NCT Number: NCT02276404

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

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Senology, Kliniken Essen-Mitte

Essen, 45136, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Relaxation Training

Behavioral

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.

Acupuncture

Other

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Registry information

Official study title

Entspannung Und Akupunktur Zur Reduktion Perioperativer Symptome Bei Brustkrebspatientinnen- Eine Randomisiert-kontrollierte Interventionsstudie im Kontext Einer Integrativ Onkologischen Versorgung (EARpeS)

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Oct 28, 2014
Registry last updated
Jun 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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