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

• Sponsor: Universität Duisburg-Essen (Other)
• Overall Status: Completed
• CT.gov ID: NCT02276404
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 4
• Actual Duration (Months): 48
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Nov 1, 2014
• Actual Primary Completion Date: Nov 1, 2018
• Actual Study Completion Date: Nov 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. presurgical psychological distress [expected average of 13 days]

   Measured by 100mm visual analog scale 1 day pre surgery

2. postsurgical pain [expected average of 15 days]

   Measured by 100mm visual analog scale 1 day post surgery

Secondary Outcome Measures

1. postsurgical psychological distress [expected average of 15 days]

   Measured by 100mm visual analog scale 1 day post surgery

2. postsurgical psychological distress [expected average of 21 days]

   Measured by 100mm visual analog scale 1 week post surgery

3. postsurgical pain [expected average of 21 days]

   Measured by 100mm visual analog scale 1 week post surgery

4. postsurgical nausea [expected average of 15 days]

   Measured by 100mm visual analog scale 1 day post surgery

5. postsurgical nausea [expected average of 21 days]

   Measured by 100mm visual analog scale 1 week post surgery

6. postsurgical fatigue [expected average of 15 days]

   Measured by 100mm visual analog scale 1 day post surgery

7. postsurgical fatigue [expected average of 21 days]

   Measured by 100mm visual analog scale 1 week post surgery

8. intraoperative analgesia use [expected average of 14 days]

   intraoperative analgesia use is taken from operative logs

9. intraoperative anesthesia use [expected average of 14 days]

   intraoperative anesthesia use is taken from operative logs

10. postoperative analgesia use [expected average of 15 days]

    postoperative analgesia use is taken from medical records

11. immunemodulation [expected average of 14 days]

    natural killer cell activity is measured at begin of surgery

12. immunemodulation [expected average of 14 days]

    natural killer cell activity is measured at end of surgery

13. Number of patients with adverse events [expected average of 21 days]

    Number of patients with adverse events are measured one week post surgery

14. presurgical psychological distress [expected average of 13 days]

    Measured by Profile of Mood States (POMS) 1 day pre surgery

15. postsurgical psychological distress [expected average of 15 days]

    Measured by Profile of Mood States (POMS) 1 day post surgery

16. postsurgical psychological distress [expected average of 21 days]

    Measured by Profile of Mood States (POMS) 1 week post surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Senology, Kliniken Essen-Mitte	Essen		Germany	45136

Sponsors and Collaborators

• Universität Duisburg-Essen

Investigators

• Study Chair: Gustav J. Dobos, Prof, Chair of Complementary and Integrative Medicine, Universitay of Duisburg-Essen, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Silke Lange, Research fellow, Universität Duisburg-Essen
• ClinicalTrials.gov Identifier: NCT02276404
• Other Study ID Numbers: 14-5778-BO
• First Posted: Oct 28, 2014
• Last Update Posted: Jun 14, 2019
• Last Verified: Jun 1, 2019

• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Jun 14, 2019