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

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ClinicalTrials.gov Identifier: NCT03651973
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : July 27, 2021
Sponsor:
Information provided by (Responsible Party):
Center Eugene Marquis

Study Description
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Brief 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.

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

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Surgery Other: Standard follow-up Other: Learning workshops Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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.
Actual Study Start Date : January 13, 2020
Estimated Primary Completion Date : February 15, 2022
Estimated Study Completion Date : August 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: With learning workshops
Patients 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.
 Other: Learning workshops
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.
Without learning workshops
Standard follow-up. Patients randomized in this arm won't attend Learning workshops and will be followed in a standard way.
 Other: Standard follow-up
Patients enrolled into standard group will be followed in a standard way without any additional procedure except randomization that allocates to the standard group


Outcome Measures
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Primary Outcome Measures :
  1. Impact of Learning workshops (self massages and self stretching) on sequelae pain after breast cancer surgery [ Time Frame: For 12 months after surgery ]
    Number of patients with chronic pain


Secondary Outcome Measures :
  1. Impact of patient quality of life [ Time Frame: at 3, 6 and 12 months ]
    Assessed by EORTC Quality of Life Questionnaire Core questionnaire 30 scale


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Woman
  • Local development of breast cancer, every stages except stage IV
  • Indication of surgery whatever surgery type except breast reconstruction
  • Age between 18 and 70 years
  • Life expectancy > 12 months assessed by surgeon or pain specialist
  • Informed and written consent
  • Affiliated to a social security system

Exclusion Criteria:

  • 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,
  • Geographical constraint (home > 50 km)
  • History of breast surgery
  • Pregnant or lactating woman
  • Protected adult or deprived of her liberty
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03651973


Contacts
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Contact: Valérie Simonnet +33 2 99 25 30 00 v.simonnet@rennes.unicancer.fr
Contact: Martine Gestin m.gestin@rennes.unicancer.fr

Locations
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France
Centre Eugène Marquis Recruiting
Rennes, France, 35042
Contact: Valérie Simonnet    +33 2 99 25 30 00    v.simonnet@rennes.unicancer.fr   
Sponsors and Collaborators
Center Eugene Marquis
Investigators
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Principal Investigator: Valérie Simonnet Centre Eugène Marquis
More Information
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Responsible Party: Center Eugene Marquis
ClinicalTrials.gov Identifier: NCT03651973    
Other Study ID Numbers: 2015-4-6-003
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: July 27, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Center Eugene Marquis:
Self massages and self stretching
Workshops for self massages and stretching learning
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases