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Breast CancerESTAUVALNCT03651973

Prevention of Sequelae Pain After Breast Cancer Surgery by Self-massages and Self Stretching. Impact of Learning Workshops.

A study testing Standard follow-up and Learning workshops in people with Breast Cancer and Surgery, run by Center Eugene Marquis at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Myofascial pain syndrome is a common cause of chronic pain characterized by myofascial pain and trigger points. Recommendations regarding management of pain after breast cancer don't mention myofascial syndrome despite a study suggests possible myofascial syndrome with roughly 75% of patients in pain. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer, Surgery
What is being tested?
Standard follow-up and Learning workshops
Could I receive a placebo?
No, everyone receives an active treatment
How many people
143 participants
Where
1 siteFrance
Study dates
13 Jan 2020to 25 Sep 2025
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Woman
  • Local development of breast cancer, every stages except stage IV
  • Indication of surgery whatever surgery type except breast reconstruction
  • More than18 years
  • Life expectancy > 12 months assessed by surgeon or pain specialist
  • Informed and written consent
  • Affiliated to a social security system

Who cannot join

  • History of chronic pain
  • History of shoulder pain
  • Any illness or severe disease, medical or psychiatric, that could prevent the patient to follow study procedures or to give her informed consent, according investigators,
  • History of breast surgery
  • Pregnant or lactating woman
  • Protected adult or deprived of her liberty

Trial locations and contacts

1 site in 1 country.

France1 site
  • Centre Eugène Marquis

    Rennes, 35042

Other trials in France

About this study

Official title: Prevention of Sequelae Pain After Breast Cancer Surgery by Daily Self Massages and Self Stretching of Serratus Anterior Muscle, Pectoralis Major Muscle, Infraspinatus Muscle and Latissimus Dorsi Muscle: Impact of Learning Workshops Performed by a Multidisciplinary Team.

Myofascial pain syndrome is a common cause of chronic pain characterized by myofascial pain and trigger points. Recommendations regarding management of pain after breast cancer don't mention myofascial syndrome despite a study suggests possible myofascial syndrome with roughly 75% of patients in pain.

144 patients having a local breast cancer requiring surgery will be randomized in this study, ratio 1:1 standard and experimental groups.

Read more

Every patients (standard and experimental groups) will attend 4 specific consultations during which standard recommendations will be given, pain, quality of life, shoulder range of motion, global upper limbs force will be assessed.

In addition, patient randomized in experimental group will attend self massages and self stretching workshops, one before surgery and one after surgery. Patients will be encouraged to performed daily self massages and self stretching.

The aim of the study is to assess impact of self massages and self stretching workshops on sequelae pain further surgery for breast cancer.

Being tested
Standard follow-up, Learning workshops
Keywords
Self massages and self stretching, Workshops for self massages and stretching learning
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard follow-upOther

    Patients enrolled into standard group will be followed in a standard way without any additional procedure except randomization that allocates to the standard group

  • Learning workshopsOther

    Patients enrolled into experimental arm will participate to educative workshops before and after surgery for breast cancer. The aim of these workshop is to educate patient to self massages and self stretching.

Study groups in NCT03651973
Study groupRoleWhat they receive
With learning workshopsExperimentalPatients in experimental arm will attend learning workshops, one before breast cancer surgey and one after surgery. Patients will be educated by physiologist to self massages and self stretching. Each workshop will last around 2 hours.
Receives: Other: Learning workshops
Without learning workshopsOtherStandard follow-up. Patients randomized in this arm won't attend Learning workshops and will be followed in a standard way.
Receives: Other: Standard follow-up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Impact of Learning workshops (self massages and self stretching) on sequelae pain after breast cancer surgery

    Number of patients with chronic pain

    Measured: For 12 months after surgery

Secondary outcomes (1)
  1. Impact of patient quality of life

    Assessed by EORTC Quality of Life Questionnaire Core questionnaire 30 scale

    Measured: at 3, 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2018
  2. Study start13 Jan 2020
  3. Primary completion25 Sep 2025
  4. Study completion25 Sep 2025

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
143 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03651973
Sponsor's protocol ID
2015-4-6-003
Acronym
ESTAUVAL
Status last verified
Mar 2026
First submitted
4 Jul 2018
Last updated
19 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Standard follow-up and Learning workshops in people with Breast Cancer and Surgery, run by Center Eugene Marquis at 1 site in France.

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 7 inclusion and 6 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 19 Mar 2026. 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 France. 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?

Impact of Learning workshops (self massages and self stretching) on sequelae pain after breast cancer surgery (time frame: For 12 months after surgery). 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 19 Mar 2026.

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