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

Musculoskeletal Diseases

Nervous System Diseases

Wounds and Injuries

Syndrome

Myalgia

Carpal Tunnel Syndrome

Arthralgia

Muscular Diseases

Neuromuscular Diseases

Musculoskeletal Pain

Neurologic Manifestations

All Drugs and Chemicals

Hormones

Estrogens

Aromatase Inhibitors

The first group will receive a decalogue of healthy tips (general, to lead an active life) based on the best available evidence, and several strips of neuromuscular bandage will be applied on areas that refer pain (cervical, lumbosacral, both or wrist-forearm).

Neuromuscular taping

Antonio I Cuesta-Vargas, PhD

Inmaculada Conejo-Tirado

Background: It has been demonstrated that aromatase inhibitors (AIs) are more effective than tamoxifen in reducing breast cancer recurrence. However, despite the excellent results, the side effects associated with them cause between 24.5 and 31.3% therapy abandon. This study aimed to verify the effectiveness of Neuromuscular Taping (NMT) in the treatment of myalgia and arthralgia induced by AIs in women who have had breast cancer. Our goal is to improve their pain, decreasing by 20% the values of their Visual Analogue Scale (VAS) at various points in order to improve symptoms and increase adherence.

Methods/Design: The study includes 156 breast cancer survivors treated with endocrine therapy (aromatase inhibitors or tamoxifen and aromatase inhibitors) from Virgen de la Victoria Hospital (Málaga, Spain) and musculoskeletal disorders resulting from such treatment. Clinical and patient data were obtained from medical histories, genetic and proteomic analysis, grip strength and algometry measured, questionnaires and the outcome of interest, their VAS. NMT is applied in four possible locations, according to the symptoms of each participant: carpal tunnel, cervical, lumbar or lumbar and cervical. There are several more interventions before repeating the readings from the last five weeks of the start of the study.

Effect of Kinesiotaping for the Treatment of Hormone-induced Myalgia in Women Given Breast Cancer Survivors

Effect of Kinesiotaping for the Treatment of Hormone-induced Myalgia in Women: Randomised Controlled Trial

A record will be kept of some medical data such as tumor grade, types carried, complementary treatments and end date, and the type of hormone therapy received and start date. The possible presence of comorbidities will also be collected.

Genetic determinants. Analyze genetic determinants due to the importance of genetic background on AIA and abandonment of therapy (Garcia-Giralt N., 2013). Estrogen receptor 1 (ESR1), aromatase (CYP19A1) and steroid, 17-alpha-hydroxylase / 17,20 lyase (CYP17A1) (Garcia-Giralt N., 2013), (Henry NL, 2012) and (Mao JJ, 2011) have been selected as candidate genes.

Samples for extracting genes will be collected in both cases with controls on the baseline and the end of it. The DNA is extracted from whole blood using the DNA Blood Maxi Qiafilter (Qiagen, Inc., Valencia, CA) (Henry NL, 2013) kit.

This questionnaire will contain information on the following variables: gender and date of birth, marital status... Add basic anthropometric data such as weight, height, BMI, waist circumference and hip.

For our analysis investigators use four plasma proteins: serum amyloid A, collectin, immunoglobulin G (IgG) light chain kappa and add C1Q (Minton O., 2013).

The pain threshold pressure is defined as the minimum amount of pressure with which an initial feeling of pressure switches to pain. (Vanderweeën L. 1996). PPT measurements were performed on:

* Cervical Musculature in space interapofisario C5-C6.
* Lumbosacral Musculature: an L4 level on the erector spinae muscle.
* Median nerve as it passes through the carpal bones.

This instrument will be used to measure grip strength of both upper limbs. This test of strength has been previously used to measure the loss of strength in breast cancer survivors (Kaya T, 2010), even in cases where patients were treated with IAs (Lintermans A., 2011) . The dynamometer has proven to be the safest \[ICC = 0.98\] and most valid \[ICC = 0.99\] method to measure grip strength of the hand. (Bellace JV, 2000).

This is a scale to measure the profile of mood states. It consists of 65 items with five possible answers. The questionnaire delivered to patients is frequently used for study of breast cancer survivors (Cantarero-Villanueva, 2011). The reliability of the Spanish version of the POMS is high (Cronbach's α ranging from .76 to 0.91).

Tool used to determine the degree of perception that cancer patients have of their feelings of fatigue and how it alters their quality of life.

This short version of the questionnaire proved to be adequate, with values of Kaiser-Meyer-Oklin (0.89) and Bartlett's sphericity test (P \<0.001) index. The goodness of fit indices of confirmatory factor analysis are (normed fit index = 0.91 and = 0.92 comparative rate setting) satisfactory. The test-retest reliability of this questionnaire is very good (r = 0.947, P \<0.001). (AI Cuesta-Vargas, 2013).

This is a specific questionnaire for cancer, "core", created by the EORTC Group. It consists of 30 items to assess HRQOL and physical, emotional, social status and overall functioning of patients diagnosed with cancer. The questions refer to the last week from the date on which the respondent completed the form. It is organised in several multi-item scales and some independent items. The reliability of the QLQ-C30 is adequate, with Cronbach Alpha values between 0.52 and 0.89 in different scales. (Moro D.,2011)

The Visual Analogue Scale (VAS) was designed to allow a subjective assessment of pain. A VAS is usually a horizontal line of 10 cm. with perpendicular lines at the ends, which are defined as the extreme limits of the painful experience. Previous studies have shown that the VAS has adequate psychometric properties, including test-retest reliability (r = 0.78) and convergent validity with other measures of pain such as the McGill Pain Questionnaire (r = 0.49 to 0.65) (Sriwatanakul K ., 1983).

For this study we will use the Spanish version (SFI-Sp), since it has proven to be a valid and reliable measure of the spinal region result. This regional tool reflects the status and any change in the kinetic chain of the spine. This questionnaire has demonstrated high internal consistency (α = 0.85) and reliability (r = 0.96) (AI Cuesta-Vargas, 2014).

This study uses the Spanish version (ULFI-Sp). This questionnaire has demonstrated high internal consistency (α = 0.94) and reliability (r = 0.93), making it a very useful tool for the evaluation of patients with disorders of the upper limbs, in both the clinical and research fields (AI Cuesta-Vargas, 2013).

This Index includes a score for five movements of the trunk upright that result in Back Pain Index (BAI) and a record of "Morning Stiffness in the Back" (MBS). The sum of the BAI and MBS gives the BADIX (max. 20 points) (Kovacs FM, 2002).

The BADIX appears to be a valid and reliable tool for the evaluation of morning stiffness restricting the mobility of the back, and discriminates whether the result of a treatment has been successful or not. (Farasyn A., 2013).

This new Back Pain Disability index seems reliable (test-retest after 3 days) and is valid in the case of significant clinical change; it has also been shown to have discriminatory power and effect size comparable to other indices in assessing disability of patients with low back pain sensitivity. (Farasyn A., 2013).

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
Effect of Kinesiotaping for the Treatment of Hormone-induced Myalgia in Women Given Breast Cancer Survivors	NCT02406794	Breast Neoplasm...	Neuromuscular t...	18 Years -	University of Malaga
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
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

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