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NCT Number: NCT05278741

Functional Evaluation After Breast Reconstruction With a Minimally Invasive Latissimus Dorsi Flap Following Radical Surgery for Breast Cancer.

This study will quantify the muscle function after breast reconstruction using a minimally invasive latissimus dorsi flap.

The proposed measures (clinical, isokinetic, electrophysiology, function and quality of life questionnaires) allow a precise, multidisciplinary, objective evaluation of the capacity of the latissimus dorsi muscle before surgery, 3 months, 6 months and 12 months after surgery. A function deficit is expected (decreased moment of adduction and internal rotation) 3 months after surgery and a return to the preoperative state 6 months and 12 months after surgery.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Georges-François Leclerc

Dijon, Côte d'Or, 21000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria:
  • Patient managed for unilateral MR (immediate or secondary) by MSLD after therapeutic mastectomy.
  • Breast assessment (Mammography + ultrasound +/- breast MRI) normal dating less than 6 months
  • Age between 18 and 80 years old
  • Signature of free and informed consent
  • Exclusion Criteria:
  • Patient with metastasis or disease progression
  • Patient whose general condition does not allow her to answer a questionnaire or perform physical and functional measurements (neurocognitive disorders and/or neuro-orthopedic disorders)
  • Patient with a poor understanding of the French language
  • Patient having presented a failure of a first breast reconstruction (failure of DIEP, prosthesis removal)
  • Patient not eligible for MR secondary to cancer (prophylactic mastectomy) or for which the flap was intended to cover loss of substance and not reconstruction
  • Patient with a history of contralateral MR (all techniques combined)
  • Patient with a history of contralateral breast cancer
  • Patient does not have internet access to be able to connect to the "Exolis" software

Treatment and study plan

Surgery for unilateral breast reconstruction

Procedure

Before the surgery, patient will be completed two questionnaire DASH and BREAST-Q. Two tests will be performed (isokinetic test and EMG).

After the surgery, at one month : 2 Questionnaires (DASH / BREAST-Q) will be performed At three months, six months and 12 months: 2 questionnaires + two tests will be perfomed

Primary outcomes

  1. Measurement of the muscular moment

    Time frame: During the 12 months post operation

    Measurement of the muscular moment of shoulder adduction preoperatively and at 3 months on an isokinetic dynamometer (Biodex®, New York, USA) at an adduction speed of 60 degrees per second during a maximal voluntary contraction

Secondary outcomes

  1. Evaluation of muscle moments

    Time frame: During the 12 months post operation

    Evaluation of muscle moments, isokinetic measurements, performed on an isokinetic dynamometer (Biodex®, New York, USA) at different speeds (isometric, 30, 60 and 120 degrees per second) of adduction and internal rotation after flap surgery minimally invasive latissimus dorsi (measurements before surgery, at 3, 6 and 12 months)

  2. Comparison of muscular moments

    Time frame: During the 12 months post operation

    Comparison of muscular moments on the operated and "healthy" sides at 3 months, 6 months and 12 months. Perfomed on an isokinetic dynamometer (Biodex®, New York, USA) at different speeds (isometric, 30, 60 and 120 degrees per second) of adduction and internal rotation after flap surgery minimally invasive latissimus dorsi

  3. Calculation of adduction deficit

    Time frame: During the 12 months post operation

    Calculation of adduction deficit is defined as a relative difference of more than 5% compared to the measurement taken preoperatively. Patients who completed at least one physiotherapy session post-surgery and before 3 months will be compared to the others.

  4. Measurement of surface electromyographic activity

    Time frame: During the 12 months post operation

    Measurement of surface electromyographic activity (sEMG) of the latissimus dorsi, teres major and pectoralis major muscles is measured before surgery, 3 months, 6 months and 12 months post-surgery

  5. Functional clinical impact and quality of life

    Time frame: During the 12 months post operation

    Functional clinical impact and quality of life is evaluated by DASH questionnaire. These questionnaire will be administrated before surgery, 1 month, 3 months, 6 months and 12 months post-surgery.

    The DASH self-questionnaire is an upper limb function assessment scale. It offers the ability to perform 23 activities, the severity of the symptoms and optional sports or instrumental and professional activity.

  6. Functional clinical impact and quality of life

    Time frame: During the 12 months post operation

    Functional clinical impact and quality of life is evaluated by BREAST-Q questionnaire. These questionnaire will be administrated before surgery, 1 month, 3 months, 6 months and 12 months post-surgery.

    The BREAST-Q questionnaire is a self-administered quality of life questionnaire assessing satisfaction after breast reconstruction.

Sponsors and collaborators

Lead sponsor

Centre Georges Francois Leclerc

Other

Registry information

Acronym: BREAST

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 14, 2022
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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