Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Ebru Calik Kutukcu, PhD

Breast cancer is one of the most common cancers among women in the world and its incidence reaches up to 16%.Although survival can be increased with early diagnosis and more effective therapies, physical complications such as lymphedema, upper extremity dysfunction and chronic pain are frequently seen during and/or after breast cancer treatments. It has been determined that lymphedema associated with breast cancer treatment is a factor that mediates and/or exacerbates the adverse effects of breast cancer treatments on upper extremity functional capacity and quality of life of patients.It was determined that the 6 Minute Pegboard and Ring Test (6PRT) score showed a clear relationship with the upper extremity daily living activities (ADLs), and it was concluded that the 6 Minute Pegboard and Ring Test (6PRT) test could be used as an appropriate test in pulmonary rehabilitation programs to predict and show the improvement of daily living activities (ADLs). Therefore, in this study; The results to be obtained by evaluating the validity and reliability of the 6 Minute Pegboard and Ring Test (6PRT) test in breast cancer patients will increase the use of this test in both testing arm endurance and arm exercise capacity in breast cancer patients, and predicting the effect on daily living activities (ADLs)

Breast cancer is one of the most common cancers in the world and it can be diagnosed as high as 16 percent. According to a 2016 report published by the Ministry of Health, the incidence of breast cancer in Turkey is 46.8 per 100,000 people and 17,000 women are diagnosed with breast cancer each year. While breast cancer survival rate is 80 percent in developed countries, it varies between 40 and 60 percent in low-middle income countries. While early diagnosis and more effective therapies may improve survival time, physical complications such as lymphedema, upper extremity dysfunctions and chronic pain are frequent during and/or following breast cancer treatments. Breast cancer treatment-related lymphoma is one of the most common complications that scare and disturb patients. In the report of the International Society of Lymphology (ISL), lymphedema is defined as a disease that occurs as a result of water, plasma proteins, extravascular fluid and parenchymal cell accumulation in the interstitial area depending on the low transport capacity of the lymphatic system. In secondary lymphedema, the reduced carrying capacity is usually associated with surgical, chemotherapy and/or radiotherapy related cancer treatments. The incidence of secondary upper limb lymphedema related to breast cancer treatment was found to be 16%. In the latest clinical guide on the assessment and treatment of lymphedema after the treatment of breast cancer, the risk factors of lymphedema are examined in three groups: treatment-related, patient-related and disease-related risk factors. Risk factors associated with the treatment; axillary lymph node dissection, mastectomy, excessive removal of lymph nodes, radiotherapy and chemotherapy. Patient-related risk factors include body mass index values of 30 or above, lack of regular physical activity and exercise, and changes in weight gain after surgery. Finally, the risk factor related to the disease has been reported as the presence of metastatic lymph nodes. After the breast cancer treatment, although a good level of functional improvement is observed in most patients, it is stated that the effects of these treatments on functional capacity, daily life, work and social activities and quality of life may be significant and long-lasting. Further, it has been established that lymphedema related to breast cancer treatment is a factor that mediates and/or exacerbates the negative effects of breast cancer treatments on functional capacity and on the quality of life of patients. Furthermore, as the intensity of lymphoma increases in patients with lymphedema related to breast cancer treatment, there is also an increase in emotional state changes such as stress, anxiety and fear. Upper extremity lymphedema, developed following breast cancer treatment, usually affects glenohumeral joint by increasing the stress in the tendons of the rotator cuff muscles and disrupting the scapulohumeral rhythm. Additionally, lymphedema may cause symptoms such as a decrease in muscle strength and mobility width of upper extremity, pain and fatigue and as a result may result in reduction of activity limits and functional level of upper extremity. Another factor in reducing the capacity of the upper extremity is the development of kinesiophobia related to the affected extremity in patients. Patients are able to restrict the use of extremity to prevent exacerbation of lymphedema. The reduction in functional capacity following breast cancer treatment is frequent but as far as we know there is no validated functional test to assess upper limb exercise capacity. Given that the number of women living with breast cancer increases every year, the existence of an objective clinical test for upper limb function may be a useful evaluation method.

"6 Minute Pegboard and Ring Test (6PRT)" is a valid and reliable, practical and easy-to-use test that assesses unsupported arm endurance in patients with chronic obstructive pulmonary disease (COPD), asthmatic patients and healthy persons. For the test, patients are asked to carry as many rings as possible within 6 minutes and the number of rings carried over for 6 minutes is recorded as a score. A study in patients with mild-to-very severe chronic obstructive pulmonary disease (COPD) has shown a positive association between the 6PRT score and the activity counts assessed by an accelerometer. Furthermore, it has been established that the 6PRT score represents a clear association with the upper extremity daily living activities (ADLs) and it has been concluded that the 6PRT test can be used as an appropriate test for the prediction and development of daily living activities (ADLs) in pulmonary rehabilitation programs. As a result, in this study; Results based on assessing the validity and reliability of the 6PRT test for breast cancer patients will increase the use of the test to predict the effect on daily living activities (ADLs) in patients with breast cancer, both on arm endurance and arm exercise capacity.

Demographic information: name, age, diagnosis, medical history (months of surgery), release form of lymphoma, treatments for lymphoma, radiotherapy (number of days), chemotherapy (number of cycles), surgical type (lumpectomy, segmental mastectomy, modified radical mastectomy, radical mastectomy), body weight, height, BMI dominant and affected side, curriculum vitae (CV), family history, lifestyle traits (smoking, exercise habit) will be recorded.

Arm length, arm and underarm circumference: We analyzed that your participants perimeter and length measurements of dominant side arms shall be measured using a measuring tape. If participants have developed lymphedema, the extremities of the related party will not be evaluated. Length of the arm shall be measured from acromion- to lateral limit of radial styloid process when the arm is in anatomic position. The radius of the arm shall be measured from the mid-zone between the acromion and the olecranon, around the forearm as well as the area where the arm reaches its largest diameter while it is relaxed near the body.

Evaluation of the Hand Grip Force: The hand gripping force shall be measured with the person bent by an elbow in a sitting position with his/her back vertically upright (the person's arm is attached to the body, in a neutral position and the elbow bent by 90 degrees, the wrist is neutral). For the dominant and non-dominant side measurements shall be repeated three times. Three measurements shall be averaged for both sides and recorded in Newtons (N).

Assessment of Shoulder Joint Movement Openness: Shoulder, flexion, extension, abduction, internal and external rotation joint mobility openings shall be measured actively and/or passively and the results shall be recorded as "limited" or "no limitations."

Pain Threshold Assessment: The pain threshold evaluation is performed by an algometer ('J tech Algometer', USA), from the region located in the volar region of the forearm, 10 cm distal of the medial and lateral epicondylar middle point in both upper limbs. With the 1 cm2 head of the algometer, vertical pressure will be applied to the application area and the patient will be asked to say "Yes" when they feel pain with the pressure applied. The measurement will be repeated 3 times and the pressure pain threshold values will be recorded taking the arithmetic mean of the three trials. Algometer measurement of pain threshold is a non-invasive and reliable method used in literature.

Information related to lymphedema: Individuals' lymphoma effects ("present", "none") will be questioned and recorded. Lymphedema duration will be recorded numerically (years).

Evaluation of Lymphedema: The environmental measurement shall be performed separately at both upper extremities, with a mild pressure at the patient sitting, with the forearm supination, elbow full extension and arm at 90 degrees abduction, with a non-stretching measuring tape. Peripheral measurement will be performed at ulnar styloid level in the wrist and at five cm intervals from this level to axilla. According to the environmental measurement, women with a minimum difference of 2 cm between the affected and the unaffected side are considered positive for lymphedema. The affected and unaffected arm volumes shall be calculated using the cut comfort formula (frustum method). Considering the difference between dominant and non-dominant arm volumes, 3.3% volume correction will be applied in women that have a dominant arm effect. The severity of lymphedema will be determined according to the differences between the affected and unaffected arms on volumetric measurements (calculated using frustum method). (mildly severe lymphedema: 200-\<250 ml difference; moderate-severe lymphedema: 250-\<500 ml difference: severe lymphedema: \>500 ml difference).

Evaluation of Upper Extremity Functionality: Individual upper-limb functionality will be evaluated in the "Questionnaire Disability of Arm, Shoulder and Hand (DASH)" which is a short version of the "Questionnaire Quick Disability of Arm, Shoulder and Hand (Q-DASH-T). It comprises 38 statements in total and 3 subdivisions including function/symptom, business model and musicians model. The Committee assesses problems in daily life and social life, pain, neurological symptoms and problems in work and sleep patterns. The scoring is performed using a five-stage likert scale. Scoring of the upper limb events according to this scale; 1-there is no difficulty, 2-mild difficulty, 3-moderate difficulty, 4-excessive difficulty, 5-not being able to do it at all. The total score is calculated using the formula "\[(total score of items marked/number of items marked)-1\]x25" and ranges from 0-100. "0" is the score in which the functions are not affected at all and "100" is where the functions are maximum.The Questionnaire Quick Disability of Arm, Shoulder and Hand (Q-DASH-T) is the short version of Questionnaire Disability of Arm, Shoulder and Hand (DASH) consisting of 11 questions. The scoring system is same as the long version.

Assessment of Unsupported Arm Exercise Capacity and Arm Function/Endurance: Will be assessed in "6 minute Pegboard and Ring Test-6PRT." During the test, the patient is asked to sit in front of a perforated panel and for 6 minutes to move as many rings as possible, using both hands simultaneously, from two bottom holes to two upper holes. The test is run with the test by putting on a few rings before the test. Standardized encouragement is provided every minute during the test. The number of rings carried over for 6 minutes constitutes the final score. Before and after the test, pulse oximeter questions heart rate and oxygen saturation, dyspnea with modified Borg scale, overall fatigue and arm fatigue detection. For the validity of the test, the test will be repeated in the same conditions as one week apart in the same patient.

Maximal Arm Exercise Capacity Assessment: An exercise test with an arm ergometer and a maximal symptom with a limited exercise test will be evaluated and the reliability of the 6PRT test will be used as criterion.

Evaluation of Upper Extremity Muscle Endurance: The first and second subtests of the Functional Impairment Test Hand, and Neck/Shoulder/Arm (FIT-HaNSA) test will be used to assess the upper limb muscle endurance of the individuals and will be used as criteria for the reliability of the 6PRT test. The test will be performed bilateral. During the test, the patient will be asked to place three 1 kg bottles at 10 cm intervals first on a 25 cm shelf at waist level and on the other shelf at 25 cm height, resting on a 60 pulse metronome per minute until they feel that they cannot continue for 5 minutes. Then they will be asked to place the bottles in the same manner on a shelf located 25 cm below a shelf at eye level. Patients' total time will be recorded.

Reliability and Validity of The '6 Minute Pegboard and Ring Test' in Patients With Breast Cancer

Evaluation of the Reliability and Validity of The '6 Minute Pegboard and Ring Test' Unsupported Arm Function Exercise Test in Patients With Breast Cancer

Total number of rings installed within six

Hacettepe University

Associate Professor

Blood and Lymph Conditions

Lymphedema

Lymphatic Diseases

Exercise, Elevation, and Garment Compression

Patients will be asked to daily:

* exercise
* elevate arm
* wear an arm compression garment

Exercise, Elevation, and Compression Garment

Use of an E0650 PCD with non-sequential waveform for two hours every day.

E0650 PCD with non-sequential waveform

Use of an E0651 PCD with sequential, non-gradient waveform for two hours every day

E0651 PCD with sequential, non-gradient waveform

Use of an E0652 PCD with sequential, gradient waveform for two hours every day.

E0652 PCD with sequential, gradient waveform

Use the E0652 PCD with peristaltic pulse waveform for two hours every day.

E0652 PCD with peristaltic pulse waveform

Arin K Greene, MD, MMSc

The purpose of this study is to determine how well different treatments for acquired lymphedema work.

The study will compare 5 different non-invasive treatments for acquired lymphedema of the arm to see which treats lymphedema best.

This study will compare 5 non-invasive lymphedema treatments.

Patients will be assigned to either:

- A combination of arm exercises, arm elevation, and wearing of a compression garment every day

OR

- One of four possible pneumatic compression devices for just two hours every day.

Pneumatic compression devices are made up of an inflatable sleeve connected to a small controller unit that is plugged into the wall. They feel like having your blood pressure taken.

None of the treatments are experimental. None of the treatments are invasive. All the treatments are considered standard of care and are used in clinics throughout the United States. All of the treatments will be done at home.

The trial will last for 7 and 1/2 months and will require follow-up visits to monitor progress.

Pneumatic Compression Treatment For Upper Extremity Acquired Lymphedema

Trial to Compare Pneumatic Compression Treatments for Upper Extremity Acquired Lymphedema

NormaTec Industries LP

Boston Children's Hospital

Inclusion criteria were to be between 18-65 years of age, to volunteer to participate in the study, to have Stage I-III breast cancer, to have at least 15 months after breast cancer surgery, to have six months after active breast cancer treatment (i.e. surgery/chemotherapy), to have no problems in reading and/or understanding the scales and to be able to cooperate with the tests. Exclusion criteria were the presence of active infection, musculoskeletal and neurologic disease that may affect exercise performance, symptomatic heart disease, neurologic disease or other clinical diagnosis that may affect cognitive status.

The inclusion criteria were to be between 18-65 years of age, to be willing to participate in the study, to have no problems in reading and/or understanding the scales and to be able to cooperate with the tests. Exclusion criteria were having any orthopedic or neuromuscular condition that would interfere with walking or exercise performance, having any chronic disease, or having psychiatric disorders or mental disorders that might interfere with cooperation or compliance with exercise tests.

Maximal Exercise Capacity, Maximal Oxygen Consumption (VO2max)

Naciye Vardar-Yagli, PhD

Melda Saglam, PhD

Breast cancer is the most common type of cancer among women worldwide. The incidence rate has reached approximately 16%. According to 2016 data from the Ministry of Health, the incidence of breast cancer in Turkey is 46.8 per 100,000 people and approximately 17,000 women are diagnosed with breast cancer each year. While breast cancer survival rate is 80% in developed countries, this rate varies between 40-60% in low-middle income countries. Survival can be increased with early diagnosis and more effective treatment methods. However, a wide range of treatment-related complications are observed during and/or after breast cancer treatment. Cancer survivors are exposed to a variety of direct (local/regional therapy, systemic therapy and supportive care) and indirect factors (modifiable and non-modifiable risk factors) that can have adverse effects on pulmonary, cardiovascular, hematologic and musculoskeletal components. Oxygen consumption in cancer patients may be adversely affected by aging, deconditioning, existing comorbidities, cancer pathophysiology and cancer treatments (surgery, radiation, chemotherapy and hormone therapy). Although decreased functional capacity is common after breast cancer treatment, there are few studies evaluating maximal arm exercise capacity with oxygen consumption.

In recent years, thanks to the increasing treatment possibilities with the developing technology, the majority of patients show good functional recovery after breast cancer. However, it has been reported that the treatments negatively affect the functional capacity of the upper extremities, daily life, work and social activities and reduce the quality of life. It has also been reported that breast cancer-related lymphedema (BCRL) may both cause and exacerbate treatment-related complications such as decreased functional capacity of the upper extremities and worsened quality of life after breast cancer treatments. In addition, it has been found that lymphedema decreases the muscle strength and range of motion of the limb in which it develops and causes an increase in symptoms such as pain, fatigue and discomfort. These complications caused by lymphedema lead to decreased functional level of the upper extremity, activity limitations and decreased quality of life. Cardiovascular health is negatively affected after breast cancer. Decreased cardiorespiratory performance also has direct consequences on daily task performance and therefore quality of life is negatively affected.

The gold standard method of measuring cardiorespiratory exercise capacity is cardiopulmonary exercise testing (CPET). This method determines the causes of limitation during exercise and gives maximal oxygen consumption (VO2max) as a measure of maximum performance. In cancer patients, the oxygen system may be adversely affected by chemotherapy. Effects of chemotherapeutic agents on respiratory, cardiac, blood, vascular or skeletal muscle functions have been observed, potentially contributing to impaired cardiorespiratory fitness. Cardiorespiratory function is not routinely measured at any stage of breast cancer treatment and CPET is rarely used in clinical settings. Although low VO2max measurements have been observed in intervention studies during breast cancer survivorship and these studies were conducted without the use of an arm ergometer, to our knowledge, there is very limited information on the impact of cancer treatment on cardiorespiratory fitness using gold standard testing methods.

Although decreased functional capacity is common after breast cancer treatment, there are few studies evaluating maximal arm exercise capacity with oxygen consumption.

Arm Exercise Capacity and Maximal Oxygen Consumption With Breast Cancer

A Comparison of Upper Extremity Exercise Capacity, Maximum Oxygen Consumption, Daily Activities, and Physical Activity Level in Breast Cancer and Healthy Individuals

European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) All scores were linearly transformed to a 0 to 100 scale. A high or healthy level of functioning is represented by a high functional score

The International Physical Activity Questionnaire - Short Form (IPAQ-SF) The physical activity status of participants was grouped as follows: (a) inactive \[≤600 metabolic equivalent MET)-min/week\]; (b) minimum active (\>600 up to ≤3000 MET-min/week); and (c) active (\>3000 MET-min/week)

McGill Pain Scale McGill pain scale determines the severity of pain and is divided into zero, which means no pain, and 10, which means severe pain;

Piper Fatigue Scale (PFS) Responses for each item It is evaluated between 0-10 points. The total fatigue score is based on 22 items scores are summed and divided by the number of items. Scale obtained from high scores indicate a high level of perceived fatigue shows.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Reliability and Validity of The '6 Minute Pegboard and Ring Test' in Patients With Breast Cancer	NCT05258344	Breast Cancer Functional Perf... Upper Extremity		18 Years - 80 Years	Hacettepe University
Pneumatic Compression Treatment For Upper Extremity Acquired Lymphedema	NCT00951067	Lymphedema	Exercise, Eleva... E0650 PCD with ... E0651 PCD with ... E0652 PCD with ... E0652 PCD with ...	18 Years -	Boston Children's Hospital
Pneumatic Compression Treatment For Upper Extremity Acquired Lymphedema	NCT00951067	Lymphedema	Exercise, Eleva... E0650 PCD with ... E0651 PCD with ... E0652 PCD with ... E0652 PCD with ...	18 Years -	Boston Children's Hospital
Arm Exercise Capacity and Maximal Oxygen Consumption With Breast Cancer	NCT06018038	Breast Cancer Upper Extremity Oxygen Consumpt... Healthy	Maximal Exercis...	15 Years - 65 Years	Hacettepe University
Reliability and Validity of The '6 Minute Pegboard and Ring Test' in Patients With Breast Cancer	NCT05258344	Breast Cancer Functional Perf... Upper Extremity		18 Years - 80 Years	Hacettepe University
Pneumatic Compression Treatment For Upper Extremity Acquired Lymphedema	NCT00951067	Lymphedema	Exercise, Eleva... E0650 PCD with ... E0651 PCD with ... E0652 PCD with ... E0652 PCD with ...	18 Years -	Boston Children's Hospital
Arm Exercise Capacity and Maximal Oxygen Consumption With Breast Cancer	NCT06018038	Breast Cancer Upper Extremity Oxygen Consumpt... Healthy	Maximal Exercis...	15 Years - 65 Years	Hacettepe University

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