Breast NeoplasmsNCT02276404
Preoperative Relaxation Training and Acupuncture to Minimize Perioperative Symptoms in Breast Cancer Patients
A study testing relaxation training and acupuncture in people with Breast Neoplasms, run by Universität Duisburg-Essen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- relaxation training and acupuncture
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2014to Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- serious psychiatric disorder
- to time span to surgery shorter than 2 weeks or longer than 20 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Entspannung Und Akupunktur Zur Reduktion Perioperativer Symptome Bei Brustkrebspatientinnen- Eine Randomisiert-kontrollierte Interventionsstudie im Kontext Einer Integrativ Onkologischen Versorgung (EARpeS)
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.
- Conditions
- Breast Neoplasms
- Being tested
- relaxation training, acupuncture
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
relaxation trainingBehavioural
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| relaxation training | Experimental | Each participant of the experimental group 1 receives 2 one-hour sessions of guided relaxation training prior to surgery. Receives: 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. Receives: 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. Receives: Behavioral: relaxation training; Other: acupuncture |
| usual care | No intervention | Patients receive usual senological treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
presurgical psychological distress
Measured by 100mm visual analog scale 1 day pre surgery
Measured: expected average of 13 days
postsurgical pain
Measured by 100mm visual analog scale 1 day post surgery
Measured: expected average of 15 days
Secondary outcomes (16)
postsurgical psychological distress
Measured by 100mm visual analog scale 1 day post surgery
Measured: expected average of 15 days
postsurgical psychological distress
Measured by 100mm visual analog scale 1 week post surgery
Measured: expected average of 21 days
postsurgical pain
Measured by 100mm visual analog scale 1 week post surgery
Measured: expected average of 21 days
postsurgical nausea
Measured by 100mm visual analog scale 1 day post surgery
Measured: expected average of 15 days
postsurgical nausea
Measured by 100mm visual analog scale 1 week post surgery
Measured: expected average of 21 days
postsurgical fatigue
Measured by 100mm visual analog scale 1 day post surgery
Measured: expected average of 15 days
postsurgical fatigue
Measured by 100mm visual analog scale 1 week post surgery
Measured: expected average of 21 days
intraoperative analgesia use
intraoperative analgesia use is taken from operative logs
Measured: expected average of 14 days
intraoperative anesthesia use
intraoperative anesthesia use is taken from operative logs
Measured: expected average of 14 days
postoperative analgesia use
postoperative analgesia use is taken from medical records
Measured: expected average of 15 days
immunemodulation
natural killer cell activity is measured at begin of surgery
Measured: expected average of 14 days
immunemodulation
natural killer cell activity is measured at end of surgery
Measured: expected average of 14 days
Number of patients with adverse events
Number of patients with adverse events are measured one week post surgery
Measured: expected average of 21 days
presurgical psychological distress
Measured by Profile of Mood States (POMS) 1 day pre surgery
Measured: expected average of 13 days
postsurgical psychological distress
Measured by Profile of Mood States (POMS) 1 day post surgery
Measured: expected average of 15 days
postsurgical psychological distress
Measured by Profile of Mood States (POMS) 1 week post surgery
Measured: expected average of 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silke Lange, Universität Duisburg-Essen
- Investigators
- Gustav J. Dobos, Prof, Study chair, Chair of Complementary and Integrative Medicine, Universitay of Duisburg-Essen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02276404
- Sponsor's protocol ID
- 14-5778-BO
- Status last verified
- Jun 2019
- First submitted
- 21 Oct 2014
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Entspannung Und Akupunktur Zur Reduktion Perioperativer Symptome Bei Brustkrebspatientinnen- Eine Randomisiert-kontrollierte Interventionsstudie im Kontext Einer Integrativ Onkologischen Versorgung (EARpeS)
- ClinicalTrials.gov ID
- NCT02276404
- Acronym / sponsor ID
- 14-5778-BO
- Conditions
- Breast Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 28 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| relaxation training | Experimental | Behavioral: relaxation trainingEach participant of the experimental group 1 receives 2 one-hour sessions of guided relaxation training prior to surgery. |
| acupuncture | Experimental | Other: acupunctureEach 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. |
| relaxation training and acupuncture | Experimental | Behavioral: relaxation training, Other: acupunctureEach 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. |
| usual care | No intervention | –Patients receive usual senological treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- serious psychiatric disorder
- to time span to surgery shorter than 2 weeks or longer than 20 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| relaxation trainingThe 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. | Behavioural | relaxation training, relaxation training and acupuncture |
| acupunctureThe 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. | Other | acupuncture, relaxation training and acupuncture |
Primary outcome
presurgical psychological distress
Time frame: expected average of 13 days
Measured by 100mm visual analog scale 1 day pre surgery
postsurgical pain
Time frame: expected average of 15 days
Measured by 100mm visual analog scale 1 day post surgery
16 secondary outcomes
postsurgical psychological distress
Time frame: expected average of 15 days
postsurgical psychological distress
Time frame: expected average of 21 days
postsurgical pain
Time frame: expected average of 21 days
postsurgical nausea
Time frame: expected average of 15 days
postsurgical nausea
Time frame: expected average of 21 days
postsurgical fatigue
Time frame: expected average of 15 days
postsurgical fatigue
Time frame: expected average of 21 days
intraoperative analgesia use
Time frame: expected average of 14 days
intraoperative anesthesia use
Time frame: expected average of 14 days
postoperative analgesia use
Time frame: expected average of 15 days
immunemodulation
Time frame: expected average of 14 days
immunemodulation
Time frame: expected average of 14 days
Number of patients with adverse events
Time frame: expected average of 21 days
presurgical psychological distress
Time frame: expected average of 13 days
postsurgical psychological distress
Time frame: expected average of 15 days
postsurgical psychological distress
Time frame: expected average of 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gustav J. Dobos, Prof study chair
Chair of Complementary and Integrative Medicine, Universitay of Duisburg-Essen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing relaxation training and acupuncture in people with Breast Neoplasms, run by Universität Duisburg-Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presurgical psychological distress (time frame: expected average of 13 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2019.