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Clinical Trial With Two Physical Therapy Protocols After Breast Cancer Surgery and Immediate Reconstruction

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ClinicalTrials.gov Identifier: NCT02480842
Recruitment Status : Unknown
Verified June 2015 by Gil Facina, Federal University of São Paulo.
Recruitment status was:  Recruiting
First Posted : June 25, 2015
Last Update Posted : June 29, 2015
Sponsor:
Information provided by (Responsible Party):
Gil Facina, Federal University of São Paulo

Brief Summary:
Introduction: physical therapy is essential in preventing motor and functional complications after breast cancer surgery. However, there is no prospective randomized study of different physiotherapy approaches in patients undergoing breast cancer surgery with immediate reconstruction. Objectives: to evaluate two physical therapy protocols in patients after breast cancer surgery with immediate reconstruction. A group with shoulder exercises with limited range of motion (ROM) at 90 degrees up to a month after surgery and a group with limited ROM only up to 15 days after surgery. Specific objectives: to evaluate shoulder ROM and pain one week before the surgery on average, and 07, 15, 30, 60, 90 and 180 days after surgery; assess motor function one week before the surgery on average, and 30 and 90 days after surgery; evaluate dehiscence and seroma 07, 15, 30, 60 and 90 days after surgery; associate incidence of seroma and dehiscence with preoperative risk factors and compare all variables (shoulder ROM, pain, motor function, seroma and dehiscence) between the two groups. Methods: women with breast cancer, who will be submitted to breast surgery (radical or conservative), followed by immediate reconstruction: alloplastic (tissue expander or breast implant) or oncoplastic (breast reduction or contralateral symmetrization) will be included. Patients that will be submitted to bilateral oncology surgery, reconstruction with autologous tissue or breast surgery without reconstruction will not be included. Patients will be recruited just after surgery scheduling and will undergo preoperative evaluation. At this moment, preoperative analysis will be conducted with personal data and medical history. Patients will undergo new assessments 07, 15, 30, 60, 90 and 180 days after surgery. All patients will receive standard physiotherapy treatment for women undergoing breast reconstruction from Physical Therapy Sector. The protocol consists of early exercise, limited to 90° of shoulder ROM, starting the day after the surgery and repeated 7 days after surgery. After 15 days of surgery, the patients will be randomized into two treatment protocols. One group will start to perform exercises with free shoulder ROM. Patients will be told only to limit the movement if they feel pain. The other group will keep shoulder exercises limited to 90° up to 30 days after surgery. At that moment (one month after surgery), they will also be allowed to move the shoulder with no restriction. The evaluation of the presence of dehiscence and seroma will occur by inspection and palpation. Shoulder ROM will be investigated through active goniometry of flexion, extension, adduction, abduction, internal rotation and external rotation. The pain will be assessed with the Verbal Numerical Scale from 0 to10 and upper limb function through the DASH (Disabilities of the Arm, Shoulder and Hand Questionnaire) questionnaire.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Other: Alloplastic free ROM Other: Alloplastic limited ROM Other: Oncoplastic free ROM Other: Oncoplastic limited ROM Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial With Two Physical Therapy Protocols After Breast Cancer Surgery and Immediate Reconstruction
Study Start Date : June 2015
Estimated Primary Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Alloplastic group A

After randomization (15 days after surgery):

- Patients will start to perform exercises with free shoulder ROM. Patients will be told only to limit the movement if they feel pain.

Other: Alloplastic free ROM
Experimental: Alloplastic group B

After randomization (15 days after surgery):

- Patients will keep shoulder exercises limited to 90° up to 30 days after surgery. At that moment (one month after surgery), then patients will also be allowed to move the shoulder with no restriction

Other: Alloplastic limited ROM
Experimental: Oncoplastic group A

After randomization (15 days after surgery):

- Patients will start to perform exercises with free shoulder ROM. Patients will be told only to limit the movement if they feel pain.

Other: Oncoplastic free ROM
Experimental: Oncoplastic group B

After randomization (15 days after surgery):

- Patients will keep shoulder exercises limited to 90° up to 30 days after surgery. At that moment (one month after surgery), then patients will also be allowed to move the shoulder with no restriction

Other: Oncoplastic limited ROM



Primary Outcome Measures :
  1. Change in shoulder range of motion from preoperative assessment (one week before surgery on average) at 07 days after surgery assessment [ Time Frame: One week before surgery on average and 07 days after surgery ]
    The shoulder ROM will be assessed with a goniometer for flexion, extension, adduction, abduction, internal rotation and external rotation. The movements will be performed actively.

  2. Change in shoulder range of motion from preoperative assessment (one week before surgery on average) at 15 days after surgery assessment [ Time Frame: One week before surgery on average and 15 days after surgery ]
    The shoulder ROM will be assessed with a goniometer for flexion, extension, adduction, abduction, internal rotation and external rotation. The movements will be performed actively.

  3. Change in shoulder range of motion from preoperative assessment (one week before surgery on average) at 30 days after surgery assessment [ Time Frame: One week before surgery on average and 30 days after surgery ]
    The shoulder ROM will be assessed with a goniometer for flexion, extension, adduction, abduction, internal rotation and external rotation. The movements will be performed actively.

  4. Change in shoulder range of motion from preoperative assessment (one week before surgery on average) at 60 days after surgery assessment [ Time Frame: One week before surgery on average and 60 days after surgery ]
    The shoulder ROM will be assessed with a goniometer for flexion, extension, adduction, abduction, internal rotation and external rotation. The movements will be performed actively.

  5. Change in shoulder range of motion from preoperative assessment (one week before surgery on average) at 90 days after surgery assessment [ Time Frame: One week before surgery on average and 90 days after surgery ]
    The shoulder ROM will be assessed with a goniometer for flexion, extension, adduction, abduction, internal rotation and external rotation. The movements will be performed actively.

  6. Change in shoulder range of motion from preoperative assessment (one week before surgery on average) at 180 days after surgery assessment [ Time Frame: One week before surgery on average and 180 days after surgery ]
    The shoulder ROM will be assessed with a goniometer for flexion, extension, adduction, abduction, internal rotation and external rotation. The movements will be performed actively.


Secondary Outcome Measures :
  1. Change in self reported pain intensity from preoperative assessment (one week before surgery on average) at 07 days after surgery assessment [ Time Frame: One week before surgery on average and 07 days after surgery ]
    The pain will be evaluated with the Verbal Scale of Pain from zero to ten, where zero is no pain and ten is unbearable pain. The patient will be asked if there is pain at the moment of evaluation, and to describe the place and the degree of the pain.

  2. Change in self reported pain intensity from preoperative assessment (one week before surgery on average) at 15 days after surgery assessment [ Time Frame: One week before surgery on average and 15 days after surgery ]
    The pain will be evaluated with the Verbal Scale of Pain from zero to ten, where zero is no pain and ten is unbearable pain. The patient will be asked if there is pain at the moment of evaluation, and to describe the place and the degree of the pain.

  3. Change in self reported pain intensity from preoperative assessment (one week before surgery on average) at 30 days after surgery assessment [ Time Frame: One week before surgery on average and 30 days after surgery ]
    The pain will be evaluated with the Verbal Scale of Pain from zero to ten, where zero is no pain and ten is unbearable pain. The patient will be asked if there is pain at the moment of evaluation, and to describe the place and the degree of the pain.

  4. Change in self reported pain intensity from preoperative assessment (one week before surgery on average) at 60 days after surgery assessment [ Time Frame: One week before surgery on average and 60 days after surgery ]
    The pain will be evaluated with the Verbal Scale of Pain from zero to ten, where zero is no pain and ten is unbearable pain. The patient will be asked if there is pain at the moment of evaluation, and to describe the place and the degree of the pain.

  5. Change in self reported pain intensity from preoperative assessment (one week before surgery on average) at 90 days after surgery assessment [ Time Frame: One week before surgery on average and 90 days after surgery ]
    The pain will be evaluated with the Verbal Scale of Pain from zero to ten, where zero is no pain and ten is unbearable pain. The patient will be asked if there is pain at the moment of evaluation, and to describe the place and the degree of the pain.

  6. Change in self reported pain intensity from preoperative assessment (one week before surgery on average) at 180 days after surgery assessment [ Time Frame: One week before surgery on average and 180 days after surgery ]
    The pain will be evaluated with the Verbal Scale of Pain from zero to ten, where zero is no pain and ten is unbearable pain. The patient will be asked if there is pain at the moment of evaluation, and to describe the place and the degree of the pain.

  7. Change in upper limbs function from preoperative assessment (one week before surgery on average) at 30 days after surgery assessment [ Time Frame: One week before surgery on average and 30 days after surgery ]
    To investigate the motor shoulder function DASH (Disabilities of the Arm, Shoulder and Hand Questionnaire) questionnaire will be used. It assesses the functional capacity in upper limb diseases and measures the skills to do certain activities, as well as the symptoms. It consists of 30 self-administered questions and two optional modules, for sports or musical activities and work activities. The 30 items evaluate the degree of difficulty in the performance of activities; the intensity of the symptoms of pain, weakness, stiffness and numbness; the commitment of social activities; the difficulty to sleep and psychological commitment by reference to the week preceding the instrument application. The final score ranges from zero to one hundred, and the higher the score, the higher the upper limb dysfunction (arm, shoulder or hand).

  8. Change in upper limbs function from preoperative assessment (one week before surgery on average) at 90 days after surgery assessment [ Time Frame: One week before surgery on average and 90 days after surgery ]
    To investigate the motor shoulder function DASH (Disabilities of the Arm, Shoulder and Hand Questionnaire) questionnaire will be used. It assesses the functional capacity in upper limb diseases and measures the skills to do certain activities, as well as the symptoms. It consists of 30 self-administered questions and two optional modules, for sports or musical activities and work activities. The 30 items evaluate the degree of difficulty in the performance of activities; the intensity of the symptoms of pain, weakness, stiffness and numbness; the commitment of social activities; the difficulty to sleep and psychological commitment by reference to the week preceding the instrument application. The final score ranges from zero to one hundred, and the higher the score, the higher the upper limb dysfunction (arm, shoulder or hand).

  9. Dehiscence at 07 days after surgery assessment [ Time Frame: 07 days after surgery ]
    Dehiscence wil be assessed by inspection and palpation. It will be described "presence" or "absence" of dehiscence and its location. The wound conditions will be described, with observation of necrosis and infection. Signs of infection such as redness, hyperthermia and secretion will be reported. The size of dehiscence will be described: in relation to the amount of opening points, in case of several opened points; or in centimeters (assessed per tape). Photographic record of dehiscence will be done, for better analysis and comparison of evolution.

  10. Dehiscence at 15 days after surgery assessment [ Time Frame: 15 days after surgery ]
    Dehiscence wil be assessed by inspection and palpation. It will be described "presence" or "absence" of dehiscence and its location. The wound conditions will be described, with observation of necrosis and infection. Signs of infection such as redness, hyperthermia and secretion will be reported. The size of dehiscence will be described: in relation to the amount of opening points, in case of several opened points; or in centimeters (assessed per tape). Photographic record of dehiscence will be done, for better analysis and comparison of evolution.

  11. Dehiscence at 30 days after surgery assessment [ Time Frame: 30 days after surgery ]
    Dehiscence wil be assessed by inspection and palpation. It will be described "presence" or "absence" of dehiscence and its location. The wound conditions will be described, with observation of necrosis and infection. Signs of infection such as redness, hyperthermia and secretion will be reported. The size of dehiscence will be described: in relation to the amount of opening points, in case of several opened points; or in centimeters (assessed per tape). Photographic record of dehiscence will be done, for better analysis and comparison of evolution.

  12. Dehiscence at 60 days after surgery assessment [ Time Frame: 60 days after surgery ]
    Dehiscence wil be assessed by inspection and palpation. It will be described "presence" or "absence" of dehiscence and its location. The wound conditions will be described, with observation of necrosis and infection. Signs of infection such as redness, hyperthermia and secretion will be reported. The size of dehiscence will be described: in relation to the amount of opening points, in case of several opened points; or in centimeters (assessed per tape). Photographic record of dehiscence will be done, for better analysis and comparison of evolution.

  13. Dehiscence at 90 days after surgery assessment [ Time Frame: 90 days after surgery ]
    Dehiscence wil be assessed by inspection and palpation. It will be described "presence" or "absence" of dehiscence and its location. The wound conditions will be described, with observation of necrosis and infection. Signs of infection such as redness, hyperthermia and secretion will be reported. The size of dehiscence will be described: in relation to the amount of opening points, in case of several opened points; or in centimeters (assessed per tape). Photographic record of dehiscence will be done, for better analysis and comparison of evolution.

  14. Seroma at 07 days after surgery assessment [ Time Frame: 07 days after surgery ]
    The seroma evaluation will be performed by inspection and palpation. There will be description of "presence" or "absence" of seroma, location and the number of punctures made by the medical team and drained quantity, when necessary.

  15. Seroma at 15 days after surgery assessment [ Time Frame: 15 days after surgery ]
    The seroma evaluation will be performed by inspection and palpation. There will be description of "presence" or "absence" of seroma, location and the number of punctures made by the medical team and drained quantity, when necessary.

  16. Seroma at 30 days after surgery assessment [ Time Frame: 30 days after surgery ]
    The seroma evaluation will be performed by inspection and palpation. There will be description of "presence" or "absence" of seroma, location and the number of punctures made by the medical team and drained quantity, when necessary.

  17. Seroma at 60 days after surgery assessment [ Time Frame: 60 days after surgery ]
    The seroma evaluation will be performed by inspection and palpation. There will be description of "presence" or "absence" of seroma, location and the number of punctures made by the medical team and drained quantity, when necessary.

  18. Seroma at 90 days after surgery assessment [ Time Frame: 90 days after surgery ]
    The seroma evaluation will be performed by inspection and palpation. There will be description of "presence" or "absence" of seroma, location and the number of punctures made by the medical team and drained quantity, when necessary.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with breast cancer, who will be submitted to breast surgery (radical or conservative), followed by immediate reconstruction: alloplastic (tissue expander or breast implant) or oncoplastic (breast reduction or contralateral symmetrization).

Exclusion Criteria:

  • Patients that will be submitted to bilateral oncology surgery, reconstruction with autologous tissue or breast surgery without reconstruction. Patients with motor or neurological deficits prior to surgery, with cognitive impairment and those that do not accept to participate.
  • Patients who need to undergo new surgical procedures during the postoperative follow-up period and those who do not appear to postoperative evaluations

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): NCT02480842


Contacts
Contact: Samantha Karlla LA Rizzi, Ms 55 11 23067435 samyfisio@gmail.com
Contact: Gil Facina, PhD 55 11 55793321 gilfacina@hotmail.com

Locations
Brazil
Federal University of São Paulo Recruiting
São Paulo, Brazil, 04024002
Sponsors and Collaborators
Federal University of São Paulo

Responsible Party: Gil Facina, FUSaoPaulo PT3, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02480842     History of Changes
Other Study ID Numbers: FUSaoPaulo PT 3
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: June 29, 2015
Last Verified: June 2015

Keywords provided by Gil Facina, Federal University of São Paulo:
Breast Neoplasms
Mammaplasty
Breast Implantation
Range of Motion, Articular
Shoulder Joint
Physical Therapy Modalities

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases