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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02276404
• Other study ID #: 14-5778-BO
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: November 2018

Study information

• Verified date: June 2019
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Germany	Department of Senology, Kliniken Essen-Mitte	Essen

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	presurgical psychological distress	Measured by 100mm visual analog scale 1 day pre surgery	expected average of 13 days
Primary	postsurgical pain	Measured by 100mm visual analog scale 1 day post surgery	expected average of 15 days
Secondary	postsurgical psychological distress	Measured by 100mm visual analog scale 1 day post surgery	expected average of 15 days
Secondary	postsurgical psychological distress	Measured by 100mm visual analog scale 1 week post surgery	expected average of 21 days
Secondary	postsurgical pain	Measured by 100mm visual analog scale 1 week post surgery	expected average of 21 days
Secondary	postsurgical nausea	Measured by 100mm visual analog scale 1 day post surgery	expected average of 15 days
Secondary	postsurgical nausea	Measured by 100mm visual analog scale 1 week post surgery	expected average of 21 days
Secondary	postsurgical fatigue	Measured by 100mm visual analog scale 1 day post surgery	expected average of 15 days
Secondary	postsurgical fatigue	Measured by 100mm visual analog scale 1 week post surgery	expected average of 21 days
Secondary	intraoperative analgesia use	intraoperative analgesia use is taken from operative logs	expected average of 14 days
Secondary	intraoperative anesthesia use	intraoperative anesthesia use is taken from operative logs	expected average of 14 days
Secondary	postoperative analgesia use	postoperative analgesia use is taken from medical records	expected average of 15 days
Secondary	immunemodulation	natural killer cell activity is measured at begin of surgery	expected average of 14 days
Secondary	immunemodulation	natural killer cell activity is measured at end of surgery	expected average of 14 days
Secondary	Number of patients with adverse events	Number of patients with adverse events are measured one week post surgery	expected average of 21 days
Secondary	presurgical psychological distress	Measured by Profile of Mood States (POMS) 1 day pre surgery	expected average of 13 days
Secondary	postsurgical psychological distress	Measured by Profile of Mood States (POMS) 1 day post surgery	expected average of 15 days
Secondary	postsurgical psychological distress	Measured by Profile of Mood States (POMS) 1 week post surgery	expected average of 21 days