NCT02276404

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 28, 2014

Completed
4 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

June 14, 2019

Status Verified

June 1, 2019

Enrollment Period

4 years

First QC Date

October 21, 2014

Last Update Submit

June 13, 2019

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (2)

  • presurgical psychological distress

    Measured by 100mm visual analog scale 1 day pre surgery

    expected average of 13 days

  • postsurgical pain

    Measured by 100mm visual analog scale 1 day post surgery

    expected average of 15 days

Secondary Outcomes (16)

  • postsurgical psychological distress

    expected average of 15 days

  • postsurgical psychological distress

    expected average of 21 days

  • postsurgical pain

    expected average of 21 days

  • postsurgical nausea

    expected average of 15 days

  • postsurgical nausea

    expected average of 21 days

  • +11 more secondary outcomes

Study Arms (4)

relaxation training

EXPERIMENTAL

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

Behavioral: relaxation training

acupuncture

EXPERIMENTAL

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

relaxation training and acupuncture

EXPERIMENTAL

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 trainingOther: acupuncture

usual care

NO INTERVENTION

Patients receive usual senological treatment

Interventions

relaxation trainingBEHAVIORAL

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.

relaxation trainingrelaxation training and acupuncture
acupunctureOTHER

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.

acupuncturerelaxation training and acupuncture

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • serious psychiatric disorder
  • to time span to surgery shorter than 2 weeks or longer than 20 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Senology, Kliniken Essen-Mitte

Essen, 45136, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Relaxation TherapyAcupuncture Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Gustav J. Dobos, Prof

    Chair of Complementary and Integrative Medicine, Universitay of Duisburg-Essen, Germany

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research fellow

Study Record Dates

First Submitted

October 21, 2014

First Posted

October 28, 2014

Study Start

November 1, 2014

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

June 14, 2019

Record last verified: 2019-06

Locations

DE(1)