Clinical trial NCT02276404: Preoperative Relaxation Training and Acupuncture to Minimize Perioperative Symptoms in Breast Cancer Patients
Official title: Entspannung Und Akupunktur Zur Reduktion Perioperativer Symptome Bei Brustkrebspatientinnen- Eine Randomisiert-kontrollierte Interventionsstudie im Kontext Einer Integrativ Onkologischen Versorgung (EARpeS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2014-10-28
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: presurgical psychological distress
timeFrame: expected average of 13 days
measure: postsurgical pain
timeFrame: expected average of 15 days
Secondary outcomes:
measure: postsurgical psychological distress
timeFrame: expected average of 15 days
measure: postsurgical psychological distress
timeFrame: expected average of 21 days
measure: postsurgical pain
timeFrame: expected average of 21 days
measure: postsurgical nausea
timeFrame: expected average of 15 days
measure: postsurgical nausea
timeFrame: expected average of 21 days
measure: postsurgical fatigue
timeFrame: expected average of 15 days
measure: postsurgical fatigue
timeFrame: expected average of 21 days
measure: intraoperative analgesia use
timeFrame: expected average of 14 days
measure: intraoperative anesthesia use
timeFrame: expected average of 14 days
measure: postoperative analgesia use
timeFrame: expected average of 15 days
measure: immunemodulation
timeFrame: expected average of 14 days
measure: immunemodulation
timeFrame: expected average of 14 days
measure: Number of patients with adverse events
timeFrame: expected average of 21 days
measure: presurgical psychological distress
timeFrame: expected average of 13 days
measure: postsurgical psychological distress
timeFrame: expected average of 15 days
measure: postsurgical psychological distress
timeFrame: expected average of 21 days
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Department of Senology, Kliniken Essen-Mitte
Study officials:
affiliation: Chair of Complementary and Integrative Medicine, Universitay of Duisburg-Essen, Germany
name: Gustav J. Dobos, Prof
role: STUDY_CHAIR
References: