Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Behaviors and Mental Disorders

Breast Neoplasms

Pain

Breast Diseases

Skin Diseases

Quality of Life

All participants are going to receive physical therapy intervention after breast cancer surgery at least removal drenaige. After that, will be randomized in two groups: Group 1 are going to receive a physical therapy program supervised by a physiotherapist; Group 2 are going to receive some instructions about the same program to perfomr at home without supervision. Both groups are going to receive 3 and 6 months of rehabilitation program.

Rehabilitation after breast cancer surgery

Ivana L Ribeiro, PhD

Objectives: To evaluate the pressure pain threshold, shoulder biomechanics, cardiorespiratory function and the quality of life associated with the short and long-term physical therapy rehabilitation following breast cancer surgery. Methodology: The study presents three objectives and involves three groups of participants. Objective 1 is to develop a topographic map of pressure pain in the shoulder (using a digital pressure algometer), evaluate the biomechanics of the shoulder (using a digital inclinometer and load card), cardiorespiratory function (through frequency variability resting heart rate and distance traveled, through the six-minute walk test) and quality of life (through questionnaires of quality of life, anxiety, depression, sleep quality, upper limb functionality, fatigue and level of physical activity) between a group of women prior to the operation of breast cancer (experimental group, n = 36) and a group of asymptomatic controls for shoulder pain (control group, n = 18). Objective 2 is to evaluate the possible changes in the pain map over 24 weeks of supervised kinetic intervention (Supervised Physiotherapy experimental group, n = 18, will begin after drainage, frequency 3 times per week and duration of 60 minutes each session) compared to unsupervised kinetic intervention (Home Physiotherapy experimental group, n = 18, participants will receive an exercise booklet). Objective 3 is to evaluate the biomechanics of the shoulder, cardiorespiratory function and the quality of life with respect to the experimental group with and without kinesic supervision. To achieve objective 1, two baseline evaluations will be carried out in both experimental and control groups (considering the month prior to the surgery of the experimental group) and the average of the evaluations will be considered evaluation 1. To achieve objectives 2 and 3, evaluation 2 (after 4 weeks of intervention), 3 (after 12 weeks of intervention) and 4 (after 24 weeks of intervention) will be performed. The statistical analysis will include the examination of qualitative and quantitative variables. Statistical tests will be applied according to the normality of the data and a significance level of 5% will be adopted for all comparisons. Expected results: It is expected to identify sensory, biomechanical, cardiorespiratory and quality of life alterations in the experimental group, compared to the control group. In addition, after 24 weeks of intervention, the supervised experimental group will show improvement in all the aforementioned variables with respect to the unsupervised group.

Short and Long Term Effects of a Physical Therapy Program After Breast Cancer Surgery

Study of the Possible Sensory, Biomechanical, Cardiorespiratory and Quality of Life Adaptations Associated With Physical Therapy Rehabilitation in the Short and Long Term Postoperative of Breast Cancer

This outcome will involve data regarding to pressure pain threshold assessment over the shoulder at three and six monthes of treatment.

This outcome will involve data regarding to objective measurement that consist in to do a maximal strenth grip. The unity of measurement it is in kg.

This outcome will involve data regarding to a questionnaire of upper limb function during activity daily routine. The questionnaire has 33 questions and each one has 5 posible answers.

This outcome will involve data regarding to a questionnaire wich contains 9 preguntas and 10 differente posibilities of answers.

This outcome will involve data regarding to a questionnaire wich contains 9 questions and 10 different posibilities of answers.

This outcome will involve data regarding to functional capacity performed wiht the walking test measured by the distance performed after a walking.

This outcome will involve data regarding to heart rate variability measured with a Polar and reloj in a supine and orthostatic posture

This outcome will involve data regarding to a questionnaire of quality of life regarding symptoms of chemotherapy that affects on quality of life perception. The questionnaire has 53 questions and each one has 4 posible answers.

Universidade Federal de Sao Carlos

Principal Investigator

Assessment of scapular kinematics during arm elevation, perceived function, quality of life, range of motion and muscle strength for shoulder complex after a rehabilitation program focused on upper limb.

Physical therapy program will be done in two steps, with 8 sessions each one (twice a week for four weeks). First, 8 sessions of passive mobilization in glenohumeral joint and scapular, scar massage, lymphatic drainage, stretching exercises will be completed. Second, 8 sessions of upper limb strengthening and stretching exercises for upper limb. Each session will be completed in 1 hour (twice a week) during two months.

Upper limb function

Our objective is to identify the possible changes of three-dimensional scapula movement during arm elevation in women after breast cancer surgery and subjected to a physical therapy intervention. Also to evaluate pain, upper limb function and quality of life. Methods: Will be evaluated 25 women with a clinical diagnosis of breast cancer and 25 healthy controls women with no history of musculoskeletal disorders of upper limbs and matched with age and body mass index. Two pre-surgical evaluations in the month prior to surgical treatment of breast cancer and two post-surgical assessments are going to be assess: the first, after 4 weeks after surgery, when patients have received 8 sessions of physical therapy in upper limb; the second, after 8 weeks after surgery, when patients completed 16 sessions of physical therapy for shoulder complex . In each evaluation, bilateral scapular kinematics will be analyzed by an electromagnetic tracking device during arm elevation in scapula plane, in breast cancer group. Range of motion will by assessed by a digital inclinometer and muscle strength by a hand held dynamometer. Also, pain will be assessed by visual analog scale and upper limb function by DASH questionnaire. Quality of life is going to be evaluated by 36 questionnaire -item Short Form Health Survey (SF36).

The main disorders of upper limb related to postoperative breast cancer, as functional limitations and muscle weakness, have already been studied. Three-dimensional scapula movement can be altered after surgical treatment of this condition, but the studies are inconclusive on this topic. Objective: To identify the possible changes of three-dimensional scapula kinematics during arm elevation in women after breast cancer surgery and subjected to a physical therapy intervention. Also to evaluate pain, upper limb function and quality of life. Methods: Will be evaluated 25 women with a clinical diagnosis of breast cancer and 25 healthy controls women with no history of musculoskeletal disorders of upper limbs and matched with age and body mass index. There will be two pre-surgical evaluations in the month prior to surgical treatment of breast cancer (with an interval of one week between then) and two post-surgical assessments: the first, after 4 weeks after surgery, when patients have received 8 sessions (twice a week) of physical therapy in upper limb (passive mobilization in glenohumeral joint and scapular, scar massage, lymphatic drainage, stretching exercises); the second, after 8 weeks after surgery, when patients completed 16 sessions (twice a week) of physical therapy for shoulder complex (strengthening and stretching exercises). In each evaluation, bilateral scapular kinematics will be analyzed by an electromagnetic tracking device during arm lifting movement in scapula plane, in breast cancer group. For control group, the assessed side will be correspondent to dominant or non-dominant operated side. Flexion, abduction, external and internal rotation of each arm will be assessed by a digital inclinometer. Muscle strength of abductors and external rotators will be evaluated by a hand held dynamometer. Pain will be assessed by visual analog scale (VAS) and upper limb function will be assessed by Disabilities of the Arm and Shoulder and Hand (DASH) questionnaire. Quality of life, through the Medical Outcomes Study 36 questionnaire -item Short Form Health Survey (SF36). Statistical analysis will include analysis of qualitative and quantitative variables. Statistical tests will be applied according to the normality of the data and it will adopt a 5% of significance level for variables comparisons along evaluations. Expected results and clinical implications of the study: To provide information of shoulder and scapular biomechanics in women after surgery for breast cancer.

Surgical Intervention and Physiotherapy in Breast Cancer: Effects in Scapular Kinematics, Pain and Upper Limb Function

Scapular Kinematics and Upper Limb Function in Women Who Had Undergone Breast Cancer Surgery Subjected to Upper Limb Stretching and Strengthening Exercises Program

Three-dimensional scapular kinematics during arm elevation (scores are represented by movements of scapular angles at 30, 60, 90 and 120 degrees of humerus elevation).

The nipple-areola complex is removed, and dissection of skin flaps is performed using electrocautery. The breast tissue, including the prepectoral fascia is removed from the pectoral muscle. After the mastectomy, the skin flaps are sutured onto the pectoral muscle using polyfilament absorbable sutures (e.g. Stratafix PDS® 1 CT needle) placed at 4- to 5-cm intervals in two or three rows depending on the extent of the skin flaps. Care is taken to prevent dimpling of the skin. The axillary region is also approximated. Care is taken to prevent damage to nerves and blood vessels. No suction drains are placed. For skin closure, the edges are sutured using absorbable monofilament sutures (e.g. Biosyn l® 3-0, Monocryl® 3-0) depending on the surgeon's preference.

Mastectomy with Quilting sutures without drain placement

The nipple-areola complex is removed, and dissection of skin flaps is performed using electrocautery. The breast tissue, including the prepectoral fascia is removed from the pectoral muscle. After mastectomy no flap fixation is performed. The skin is closed in a conventional manner using an absorbable skin suture. One or two suction drains are placed before skin closure. The drains are placed in the mastectomy gutter lateral to the pectoral muscle and/or in the prepectoral area. For skin closure, the edges are sutured using absorbable monofilament sutures (e.g. Biosyn l® 3-0, Monocryl® 3-0) depending on the surgeon's preference. Drain output is recorded daily. Drain removal policy varies among participating centres. In some centres drain removal is based on volume of drained fluids while in other centres it depends on the postoperative time

Mastectomy with Conventional sutures with drain placement

Hanne Vos, PhD

Ann Smeets, MD, PhD

Ann Smeets, MD,PhD

The use of wound drains after mastectomy is common practice in Belgium. However, placement of suction drainage has several disadvantages. Skin bacteria can enter via the drain and cause infection, or the drain itself can cause discomfort and a need for daily nursing. After drain removal, seroma is the most common complication following breast cancer surgery. Seromas are collections of serous fluid that frequently develop under the skin or in the axillary space formed after mastectomy and/or axillary lymph node dissection, resulting from surgical trauma to blood/lymphatic vessels and post-traumatic inflammation. Seroma formation can cause discomfort and limitations in shoulder function. Moreover, it is associated with surgical site infections, often requires treatment and increases healthcare consumption. Wound healing problems might be a cause of postponement of adjuvant therapy.

The quilting suture technique, in which the skin is sutured to the pectoralis muscle and drain placement is not needed, may lead to a significant reduction of seroma with a decrease in the number of aspirations and surgical site infections.

In this national multicentric study, we will compare mastectomy with placement of suction drains, a standard technique used in the vast majority of Belgian hospitals, with the new quilting suture technique without placement of suction drains. We will focus on 3 distinct primary outcomes:

* Pain of the mastectomy area 6 months after surgery
* Upper limb function 6 months after surgery
* Cosmetic outcome scored by the patient 6 months after surgery.

The goal of this study is to demonstrate the absence of long-term negative effects of the quilting suture technique on shoulder function, cosmetic outcome, and pain management.

A multicentre, pragmatic randomised controlled trial

Quilting Sutures After Mastectomy

Comparison of 'Quilting Sutures' With 'Conventional Sutures and Drain Placement' After Mastectomy: a Multicentre, Pragmatic Randomised Controlled Trial

A non-inferiority margin of 10 mm was adopted, which implies that a difference between both arms up to 10 mm in favour of the standard approach would be clinically acceptable

A non-inferiority margin of 10 points was adopted, which implies that a difference between both arms up to 10 points in favour of the standard approach would be clinically acceptable.

A non-inferiority margin of 1 point on the 10-point scale was adopted which implies that a difference between both arms up to 1 point in favour of the standard approach would be clinically acceptable

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Short and Long Term Effects of a Physical Therapy Program After Breast Cancer Surgery	NCT04116281	Breast Cancer	Rehabilitation ...	18 Years - 70 Years	Universidade Federal de Sao Carlos
Surgical Intervention and Physiotherapy in Breast Cancer: Effects in Scapular Kinematics, Pain and Upper Limb Function	NCT02604030	Breast Cancer	Upper limb func...	18 Years -	Universidade Federal de Sao Carlos
Surgical Intervention and Physiotherapy in Breast Cancer: Effects in Scapular Kinematics, Pain and Upper Limb Function	NCT02604030	Breast Cancer	Upper limb func...	18 Years -	Universidade Federal de Sao Carlos
Short and Long Term Effects of a Physical Therapy Program After Breast Cancer Surgery	NCT04116281	Breast Cancer	Rehabilitation ...	18 Years - 70 Years	Universidade Federal de Sao Carlos
Quilting Sutures After Mastectomy	NCT06415032	Breast Cancer	Mastectomy with... Mastectomy with...	18 Years -	Universitaire Ziekenhuizen KU Leuven
Short and Long Term Effects of a Physical Therapy Program After Breast Cancer Surgery	NCT04116281	Breast Cancer	Rehabilitation ...	18 Years - 70 Years	Universidade Federal de Sao Carlos

Spots Global Cancer Trial Database for upper limb function