Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Edema

Seroma

Inflammation

Patients who belong to the sperimental group ("SPER") will receive the standard treatment and Kinesio tape lymphatic drainage technique application.

The experimental group also receives the expected standard treatment, consisting in physiotherapeutic evaluation and physiotherapy counseling.

Patients who belong to the control group ("CONTR") will receive only the standard treatment. Standard treatment consists in physiotherapy evaluation and counseling. The educational part, the demonstration of the exercises and the prosthesis mobilization are included in this treatment.

Kinesio Tex Tape strips are applied following Dr.Kase draining techinique. The choice of tape's length and strips' number is based on the area of breast edema and/or presence of seroma, which must be completely covered. The patch is cut into fan strips. The major base is positioned near the functioning lymph node stations closest to the edema and/or seroma area. The bases and the tails of the fan must be applied with zero tension, while for the central part is reached 15-25% of tension. The first application takes place on the 1st post-operative day, while the second is performed on the 7th post-operative day. In case the tape is detached from one application to another, it is necessary that the patient resume in the clinic for a new application to ensure continuity of the therapeutic effect; otherwise the patient is eliminated from the study. The experimental group also receives the expected standard treatment, consisting in physiotherapeutic evaluation and counselin.

Kinesio tape lymphatic drainage technique application

Stefano Martella

Over the last two decades in the field of oncology, the prevention, diagnosis, treatment and rehabilitation have reached a remarkable development, improving healing rates and reducing the number of deaths from cancer. The most frequent cancer in the female population is the breast one, which consequences can become disabling. In recent years, surgeons need to find more effective and less invasive treatments. Nowadays, despite the achievements, oncological surgery can cause side effects that cannot allow the return to normal life. Some of these problems are represented by the formation of edema and seroma, which can be handled by the physiotherapist through the manual lymphatic drainage and the application of an elastic tape. The elastic tape is used a lot in clinical practice, despite it lacks supportive evidence.

The primary aim of the study is to verify the effectiveness of Kinesio Tex Tape in reducing edema and seroma formation following complex reconstructive breast surgery. The secondary goals are the evaluation of the quality of the scar, of the perception of pain, of the degree of satisfaction and disability.

It is a controlled, monocentric, national, comparative, randomized, single-blind study. The sample size is 60 patients who undergo complex reconstructive breast surgery. Patients are divided into two groups: the experimental one (receiving standard treatment and Kinesio Tex Tape application) and a group of control (just receiving standard treatment). To evaluate edema and seroma, ultrasound is used; ultrasounds will be on the 1st, 15th and 30th postoperative days (T0, T1 and T2); Vancouver Scar Scale is used to define the quality of the scar (T0 and T2); to measure the subjective perception of pain and to evaluate the degree of patient satisfaction, two VAS scales are administered (the VAS scale for pain is administered at T0, T1 and T2, while the VAS scale for satisfaction is given at T1 and T2); Finally, to assess the degree of disability, the DASH Questionnaire is used (T0, T1 and T2).

Screening at the first evaluation:

The anamnesis for each potentially eligible patient will be performed to assess whether the inclusion and exclusion criteria are met.

If the selection criteria for inclusion in the study are met, the patient will be proposed to participate in the study with the delivery of the patient information sheet and the form will be delivered to obtain written and signed informed consent.

Only after having signed the signature on the form, the patient will in fact be eligible for the study.

Randomization assigns to each patient the treatment strategy assigned by the random process, as well as the numerical code that uniquely identifies the patient in the study.

Once the randomization has been carried out, the following information will be collected at the moment before the tape application:

* Name and surname.
* Age.
* Profession.
* Type of surgical intervention.
* Side of the surgical intervention.
* Previous or concurrent diseases.
* Eventual adverse events.
* Thickness of skin and subcutaneous tissue, detected by ultrasound.
* Thickness of liquid, detected by ultrasound.
* Pain referred by the patient (VAS Scale).
* Patient satisfaction level (VAS Scale).
* Scar quality measured by the blind surgeon (Vancouver Scar Scale)
* Disability of the patient (DASH Questionnaire)

Screening for subsequent evaluations:

The following information will be collected:

* Thickness of skin and subcutaneous tissue (edema) and serum collection (seroma) detected by ultrasound.
* Quality of the scar measured by the blind surgeon (Vancouver Scar Scale).
* Subjective pain sensation (VAS Scale).
* Patient satisfaction level (VAS Scale).
* Disability of the patient (DASH Questionnaire).

Treatment:

Kinesio Tex Tape strips are applied to the patient in the experimental group following the technique of Dr. Kenzo Kase for lymphatic drainage. The choice of tape's length and of strips' number to be applied is based on the area of the breast edema and / or presence of seroma, which must be completely covered. The patch is cut into a fan strip: a length of kinesio tex tape is solid at one end and cut to create 4-6 narrow strips or tails. Corners are rounded to prevent detachment. The application area must be clean and dry. The major base is positioned near the functioning lymph node stations closest to the edema and / or seroma area. The bases and the tails of the fan must be applied with zero tension, while for the central part is reached 15-25% of tension, which is created manually or by extending the structures involved. Tails are applied in parallel, with a small distance between them.The first application takes place on the 1st post-operative day, while the second is performed on the 7th post-operative day. In the event that the tape is detached from one application to another, it is necessary that the patient resume in the clinic for a new application, so as to ensure continuity of the therapeutic effect; otherwise, the patient is eliminated from the study. The experimental group also receives the expected standard treatment. By standard treatment we mean physiotherapeutic evaluation and physiotherapy counseling. The educational part, the demonstration of the exercises to be performed autonomously and the demonstration of prosthesis mobilization are included in this treatment.

Temporary or ultimately treatment interruption:

There are no conditions that allows to interrupt and then restart the study. If a subject decides to interrupt the study, the decision will be ultimate and a conclusion visit will be carried out in order to understand the drop out motivations; data will be analysed for intention-to-treat analysis.

• Statistics considerations

Sample size:

In order to assess the 1st co-primary endpoint (seroma resolution at 30 days) the percentages will be compared; from our clinical experience we except the 50% of subjects without tape will resolve seroma at 30 days, while 90% of subjects with kinesio-tape treatment will resolve at the same time.

In order to highlight this difference we will need to recruit 30 subjects per group with 2,5 % alpha error and 80% statistical power.

Regarding the 2nd co-primary endpoint (edema reduction), taking as reference the mean of five ultrasound breast acquisition, a size of 30 subjects in each group and a 80% statistical power will be required to determine a difference of 1.69 mm between null hypothesis which establishes the mean of both groups is 10.00 mm and alternative hypothesis establishing the 2nd group mean is 8.31 mm, taking a standard deviation of 2.00 mm for both groups.

• Statistics analysis

Demographics data and outcomes in the study will be analysed through descriptive statistics.

In case of Gaussian distribution, the continuous variables will be described through mean and standard deviation, while in case non-Gaussian distribution the continuous variables will be described through median and interquartile range. Categorical variables will be described through frequency percentages.

Considered variables' normal distribution will be verified through Shapiro-Wilk Test.

For the 1st co-primary endpoint (seroma resolution) at 30 days proportions will be compared, and in order to make the survival analysis seroma resolution times will be considered.

Curves will be estimated through Kaplan and Meier method and two groups comparison will be carried out through log-rank test.

For the 2nd co-primary endpoint (edema reduction) means at 30 days will be compared through repeated measures analysis of variance.

The analysis will be conducted through intention-to-treat population analysis, considering the two groups as randomized.

Also a confirmation analysis will be conducted on population who has correctly carried out the treatment (per-protocol population).

• Ethical and regulating considerations:

This clinical study will be conducted according to the main laws drawn up by the 18th World Medical Assembly (Helsinki, 1964) and to all the applicable amendments drawn up by World Medical Assembly, and to the ICH guide lines for Good Clinical Practice.

This clinical trial will conducted with reference to all international laws and regulations, and to national laws and regulations in force in the Nation where it is carried out, as well as to each applicable guide line.

• Informed consent:

The investigator, or a person appointed by him and under his responsibility, will inform exhaustively participants about all aspects pertaining to the clinical trial, according to all the applicable regulating dispositions.

All participants will be exhaustively informed about the study, using words and language they will be able to understand.

Before taking part to the clinical trial the subjects will have had signed the informed consent forms.

The patients will be told they will be able to drop out the study whenever they want, without any requested explanations, and that their decisions will not have any consequence.

Every informed consent will be included in the investigator's files. The patient will be given a dated and signed copy of informed consent.

Kinesio Tex Tape in Reducing Edema and Seroma After Complex Reconstructive Breast Surgery

Effectiveness of Kinesio Tex Tape Application in Reducing Edema and Seroma Formation Following Complex Reconstructive Breast Surgery

Quantity of edema is measured in millimetres, through ultrasound scan. The verification of the effectiveness of elastic tape in terms of reduction of edema will be performed through ultrasound.

During the ultrasound acquisition patients are indicated to assume the supine position on the couch, with 45 ° of humerus flexion and abduction, supported by an operator . Five points of maximum thickness of skin and subcutaneous tissue (edema) will be detected : retroareolar space, Upper-outer quadrant, Upper-inner quadrant, Lower-outer quadrant and Lower-inner quadrant. The thickness will be measured in millimeters.

Quantity of seroma is measured in millimetres, through ultrasound scan. The verification of the effectiveness of elastic tape in terms of resolution of seroma will be performed through ultrasound.

During the ultrasound acquisition patients are indicated to assume the supine position on the couch, with 45 ° of humerus flexion and abduction, supported by an operator . Five points of maximum thickness of liquid (seroma) will be detected : retroareolar space, Upper-outer quadrant, Upper-inner quadrant, Lower-outer quadrant and Lower-inner quadrant. The thickness will be measured in millimeters.

The surgeon will make the evaluation of the quality of the scar using the Vancouver Scar Scale. The scale includes the following subscales: Pigmentation (M) in which the best score is "0 = normal" and the worst is "2= Hyperpigmented" , Pliability (P) in which the best score is "0 = normal" and the worst "5 = contracture", Height (H) in which the best score is " 0 = flat" and the worst is "3 = \> 5 mm" and Vascularity (V) in which the best score is "0 = normal" and the worst is "3 = purple. The subscales' scores are summed to compute a total score, where lower values represent a better quality of the scar.

The subjective perception of pain will be measured using Visual Analogue Scale for Pain. It is a measurement tool mainly used to indicate subjective pain characteristics. It consists of a strip of 10 cm in which its extremities correspond respectively to " 0 = no pain", "10 = worst pain that I can imagine", where lower values indicate a good subjective perception of pain. The health professional asks the patient to mark the pain perceived at that moment on the scale.

The degree of patient satisfaction will be measured using Visual Analogue Scale. It consists of a strip of 10 cm in which its extremities correspond respectively to "0 = no satisfaction", "10 = maximum satisfaction", where higher values indicate a good degree of satisfaction. The health professional asks the patient to mark the satisfaction perceived at that moment on the scale.

The degree of disability will be measured using DASH scale (The Disability of the Arm, Shoulder and Hand). It is a questionnaire concerning symptoms and abilities to perform certain activities that mainly require the use of the upper limb. For each subscale (30 items) the best score is "1 = no difficulty" and the worst is "5 = unable". The patient is asked to assign a score from 1 to 5 for each activity reported by referring only to the operated side. For the activities contraindicated by the surgeon patients are suggested to give score 5, "unable".

On the 15th and 30th post-operative day the questions related to the activities of daily life refer to the past week, while on the 1st post-operative day the patients are required to consider the time passed since the intervention. The subscales' scores are summed to compute a total score, where lower values represent a lower degree of disability.

IRCCS San Raffaele

Primary Doctor of General Reconstructive Surgery Operating Unit.

Breast Diseases

Skin Diseases

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.

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

Alloplastic free ROM

Alloplastic limited ROM

Oncoplastic free ROM

Oncoplastic limited ROM

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.

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:

1. 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.
2. 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.
3. 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).
4. 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.
5. 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.

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

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

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 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.

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 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.

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 title	NCT ID	Conditions	Interventions	Eligibility	Organization
Kinesio Tex Tape in Reducing Edema and Seroma After Complex Reconstructive Breast Surgery	NCT03477565	Breast Cancer Mastectomy Breast Implanta... Edema Seroma	Kinesio tape ly...	18 Years -	IRCCS San Raffaele
Clinical Trial With Two Physical Therapy Protocols After Breast Cancer Surgery and Immediate Reconstruction	NCT02480842	Breast Neoplasm...	Alloplastic fre... Alloplastic lim... Oncoplastic fre... Oncoplastic lim...	18 Years -	Federal University of São Paulo
Clinical Trial With Two Physical Therapy Protocols After Breast Cancer Surgery and Immediate Reconstruction	NCT02480842	Breast Neoplasm...	Alloplastic fre... Alloplastic lim... Oncoplastic fre... Oncoplastic lim...	18 Years -	Federal University of São Paulo

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