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

Universität Duisburg-Essen

Status: Completed

Conditions: Breast Neoplasms

Treatments: Other: acupuncture; Behavioral: relaxation training

Study type: Interventional

Funder types: Other

Identifiers

NCT02276404

14-5778-BO

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

120 participants in 4 patient groups

relaxation training

Experimental group

Description:

Each participant of the experimental group 1 receives 2 one-hour sessions of guided relaxation training prior to surgery.

Treatment:

Behavioral: relaxation training

acupuncture

Experimental group

Description:

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.

Treatment:

Other: acupuncture

relaxation training and acupuncture

Experimental group

Description:

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.

Treatment:

Behavioral: relaxation training

Other: acupuncture

usual care

No Intervention group

Description:

Patients receive usual senological treatment