Breast NeoplasmsNCT02480842
Clinical Trial With Two Physical Therapy Protocols After Breast Cancer Surgery and Immediate Reconstruction
A study testing Alloplastic free ROM, Alloplastic limited ROM and Oncoplastic free ROM in people with Breast Neoplasms, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Alloplastic free ROM, Alloplastic limited ROM and Oncoplastic free ROM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2015to 17 Jul 2019
- 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
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial With Two Physical Therapy Protocols After Breast Cancer Surgery and Immediate Reconstruction
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.
Read the detailed description
Methods:
Patients will be recruited just after surgery scheduling. They will undergo preoperative evaluation one week before the surgery on average. 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, periods that will be described as PO 07, PO 15, PO 30, PO 60, PO 90 and PO 180.
All patients will receive standard physiotherapy treatment for women undergoing breast reconstruction from Physical Therapy Sector of Mastology Discipline of the Department of Gynecology of Federal University of São Paulo. The protocol consists of early exercise, limited to 90° of shoulder range of motion (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.
However, because of the existence of different types of reconstructive surgery, randomization will performed from two groups:
- Alloplastic group: patients who will undergo reconstruction with tissue expander or breast implant
- Oncoplastic Group: patients who will undergo mammaplasty and / or contralateral symmetrization
Computer random sequence will be used for randomization, in which each group will be randomized to Group A or Group B.
- Subgroup A: Patients will start to perform exercises with free shoulder ROM. Patients will be told only to limit the movement if they feel pain.
- Subgroup B: Patient 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
At the end of randomization there will be four subgroups: alloplastic A, alloplastic B, oncoplastic A and oncoplastic B
Outcomes:
- Shoulder range of motion: 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. The patient will be positioned in the sitting position. To assess shoulder flexion, the upper limb will be in neutral position with elbow extension. Patient will be asked to raise the arm forward, close to the body. To assess extension, the arm will be positioned with 90° of elbow flexion and the patient will be asked to take the arm back. For adduction, the patient will be with 90° of shoulder flexion with the palm down and patient will be told to move the arm medially. For the study of the upper limb abduction, the limb will be in supination and elbow extension and the patient will be asked to raise the arm to the side, along the trunk line toward the ear. For the evaluation of internal rotation and external rotation the upper limb will be placed in 90° of shoulder abduction and 90° of elbow flexion. The patient will be asked to rotate the shoulder internally and externally, respectively.
- Pain: 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.
- Upper limbs function: 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).
- Dehiscence: 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. A Nikon Coolpix S3000 camera will be used.
- Seroma:
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.
- Conditions
- Breast Neoplasms
- Being tested
- Alloplastic free ROM, Alloplastic limited ROM, Oncoplastic free ROM, Oncoplastic limited ROM
- Keywords
- Breast Neoplasms, Mammaplasty, Breast Implantation, Range of Motion, Articular, Shoulder Joint, Physical Therapy Modalities
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alloplastic free ROMOther
Alloplastic limited ROMOther
Oncoplastic free ROMOther
Oncoplastic limited ROMOther
| Study group | Role | What they receive |
|---|---|---|
| Alloplastic group A | Experimental | 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. Receives: Other: Alloplastic free ROM |
| Alloplastic group B | Experimental | 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 Receives: Other: Alloplastic limited ROM |
| Oncoplastic group A | Experimental | 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. Receives: Other: Oncoplastic free ROM |
| Oncoplastic group B | Experimental | 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 Receives: Other: Oncoplastic limited ROM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in shoulder range of motion from preoperative assessment (one week before surgery on average) at 07 days after surgery assessment
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.
Measured: One week before surgery on average and 07 days after surgery
Change in shoulder range of motion from preoperative assessment (one week before surgery on average) at 15 days after surgery assessment
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.
Measured: One week before surgery on average and 15 days after surgery
Change in shoulder range of motion from preoperative assessment (one week before surgery on average) at 30 days after surgery assessment
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.
Measured: One week before surgery on average and 30 days after surgery
Change in shoulder range of motion from preoperative assessment (one week before surgery on average) at 60 days after surgery assessment
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.
Measured: One week before surgery on average and 60 days after surgery
Change in shoulder range of motion from preoperative assessment (one week before surgery on average) at 90 days after surgery assessment
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.
Measured: One week before surgery on average and 90 days after surgery
Change in shoulder range of motion from preoperative assessment (one week before surgery on average) at 180 days after surgery assessment
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.
Measured: One week before surgery on average and 180 days after surgery
Secondary outcomes (18)
Change in self reported pain intensity from preoperative assessment (one week before surgery on average) at 07 days after surgery assessment
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.
Measured: One week before surgery on average and 07 days after surgery
Change in self reported pain intensity from preoperative assessment (one week before surgery on average) at 15 days after surgery assessment
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.
Measured: One week before surgery on average and 15 days after surgery
Change in self reported pain intensity from preoperative assessment (one week before surgery on average) at 30 days after surgery assessment
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.
Measured: One week before surgery on average and 30 days after surgery
Change in self reported pain intensity from preoperative assessment (one week before surgery on average) at 60 days after surgery assessment
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.
Measured: One week before surgery on average and 60 days after surgery
Change in self reported pain intensity from preoperative assessment (one week before surgery on average) at 90 days after surgery assessment
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.
Measured: One week before surgery on average and 90 days after surgery
Change in self reported pain intensity from preoperative assessment (one week before surgery on average) at 180 days after surgery assessment
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.
Measured: One week before surgery on average and 180 days after surgery
Change in upper limbs function from preoperative assessment (one week before surgery on average) at 30 days after surgery assessment
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).
Measured: One week before surgery on average and 30 days after surgery
Change in upper limbs function from preoperative assessment (one week before surgery on average) at 90 days after surgery assessment
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).
Measured: One week before surgery on average and 90 days after surgery
Dehiscence at 07 days after surgery assessment
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.
Measured: 07 days after surgery
Dehiscence at 15 days after surgery assessment
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.
Measured: 15 days after surgery
Dehiscence at 30 days after surgery assessment
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.
Measured: 30 days after surgery
Dehiscence at 60 days after surgery assessment
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.
Measured: 60 days after surgery
Dehiscence at 90 days after surgery assessment
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.
Measured: 90 days after surgery
Seroma at 07 days after surgery assessment
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.
Measured: 07 days after surgery
Seroma at 15 days after surgery assessment
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.
Measured: 15 days after surgery
Seroma at 30 days after surgery assessment
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.
Measured: 30 days after surgery
Seroma at 60 days after surgery assessment
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.
Measured: 60 days after surgery
Seroma at 90 days after surgery assessment
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.
Measured: 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2019
- Study completion17 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gil Facina, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480842
- Sponsor's protocol ID
- FUSaoPaulo PT 3
- Status last verified
- Jul 2019
- First submitted
- 17 Jun 2015
- Last updated
- 1 Aug 2019
- Results posted
- No
Publications
de Almeida Rizzi SKL, Haddad CAS, Giron PS, Figueira PVG, Estevao A, Elias S, Nazario ACP, Facina G. Early Free Range-of-Motion Upper Limb Exercises After Mastectomy and Immediate Implant-Based Reconstruction Are Safe and Beneficial: A Randomized Trial. Ann Surg Oncol. 2020 Nov;27(12):4750-4759. doi: 10.1245/s10434-020-08882-z. Epub 2020 Jul 28.
PubMed 32725529
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial With Two Physical Therapy Protocols After Breast Cancer Surgery and Immediate Reconstruction
- ClinicalTrials.gov ID
- NCT02480842
- Acronym / sponsor ID
- FUSaoPaulo PT 3
- Conditions
- Breast Neoplasms
- Keywords
- Breast Neoplasms, Mammaplasty, Breast Implantation, Range of Motion, Articular, Shoulder Joint, Physical Therapy Modalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- 17 Jul 2019 (actual)
- First posted
- 25 Jun 2015 (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.
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.
Detailed description
Methods:
Patients will be recruited just after surgery scheduling. They will undergo preoperative evaluation one week before the surgery on average. 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, periods that will be described as PO 07, PO 15, PO 30, PO 60, PO 90 and PO 180.
All patients will receive standard physiotherapy treatment for women undergoing breast reconstruction from Physical Therapy Sector of Mastology Discipline of the Department of Gynecology of Federal University of São Paulo. The protocol consists of early exercise, limited to 90° of shoulder range of motion (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.
However, because of the existence of different types of reconstructive surgery, randomization will performed from two groups:
- Alloplastic group: patients who will undergo reconstruction with tissue expander or breast implant
- Oncoplastic Group: patients who will undergo mammaplasty and / or contralateral symmetrization
Computer random sequence will be used for randomization, in which each group will be randomized to Group A or Group B.
- Subgroup A: Patients will start to perform exercises with free shoulder ROM. Patients will be told only to limit the movement if they feel pain.
- Subgroup B: Patient 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
At the end of randomization there will be four subgroups: alloplastic A, alloplastic B, oncoplastic A and oncoplastic B
Outcomes:
- Shoulder range of motion: 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. The patient will be positioned in the sitting position. To assess shoulder flexion, the upper limb will be in neutral position with elbow extension. Patient will be asked to raise the arm forward, close to the body. To assess extension, the arm will be positioned with 90° of elbow flexion and the patient will be asked to take the arm back. For adduction, the patient will be with 90° of shoulder flexion with the palm down and patient will be told to move the arm medially. For the study of the upper limb abduction, the limb will be in supination and elbow extension and the patient will be asked to raise the arm to the side, along the trunk line toward the ear. For the evaluation of internal rotation and external rotation the upper limb will be placed in 90° of shoulder abduction and 90° of elbow flexion. The patient will be asked to rotate the shoulder internally and externally, respectively.
- Pain: 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.
- Upper limbs function: 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).
- Dehiscence: 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. A Nikon Coolpix S3000 camera will be used.
- Seroma:
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Alloplastic group A | Experimental | Other: Alloplastic free ROMAfter 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. |
| Alloplastic group B | Experimental | Other: Alloplastic limited ROMAfter 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 |
| Oncoplastic group A | Experimental | Other: Oncoplastic free ROMAfter 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. |
| Oncoplastic group B | Experimental | Other: Oncoplastic limited ROMAfter 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Alloplastic free ROM | Other | Alloplastic group A |
| Alloplastic limited ROM | Other | Alloplastic group B |
| Oncoplastic free ROM | Other | Oncoplastic group A |
| Oncoplastic limited ROM | Other | Oncoplastic group B |
Primary outcome
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.
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.
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.
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.
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.
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.
18 secondary outcomes
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
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
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
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
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
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
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
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
Dehiscence at 07 days after surgery assessment
Time frame: 07 days after surgery
Dehiscence at 15 days after surgery assessment
Time frame: 15 days after surgery
Dehiscence at 30 days after surgery assessment
Time frame: 30 days after surgery
Dehiscence at 60 days after surgery assessment
Time frame: 60 days after surgery
Dehiscence at 90 days after surgery assessment
Time frame: 90 days after surgery
Seroma at 07 days after surgery assessment
Time frame: 07 days after surgery
Seroma at 15 days after surgery assessment
Time frame: 15 days after surgery
Seroma at 30 days after surgery assessment
Time frame: 30 days after surgery
Seroma at 60 days after surgery assessment
Time frame: 60 days after surgery
Seroma at 90 days after surgery assessment
Time frame: 90 days after surgery
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 1 Aug 2019.
- Derived from this study: PubMed 32725529de Almeida Rizzi SKL, Haddad CAS, Giron PS, Figueira PVG, Estevao A, Elias S, Nazario ACP, Facina G. Early Free Range-of-Motion Upper Limb Exercises After Mastectomy and Immediate Implant-Based Reconstruction Are Safe and Beneficial: A Randomized Trial. Ann Surg Oncol. 2020 Nov;27(12):4750-4759. doi: 10.1245/s10434-020-08882-z. Epub 2020 Jul 28.
Related trials for Breast Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alloplastic free ROM, Alloplastic limited ROM and Oncoplastic free ROM in people with Breast Neoplasms, run by Federal University of São Paulo at 1 site in Brazil.
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 1 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 1 Aug 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 Brazil. 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?
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 study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02480842, which also lists 1 linked publication.
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 1 Aug 2019.