Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Women and men diagnosed with breast cancer waiting for surgery

assessment of UL function and prognostic factors

An De Groef, Prof. Dr.

Nieke Vets

An De Groef, Prof

Nieke Vets, PhD

Breast cancer is the most frequently occurring cancer, assuming that it accounts for 29% of all new cancers in women (European Cancer Information System). The number of long-term survivors is increasing rapidly due to improving accuracy of the detecting methods, the early diagnosis and advances in cancer treatment.

The International Consortium for Health Outcomes Measurement Initiative described upper limb (UL) function as the health outcome that matters most for breast cancer survivors (BCS). 50% of BCS at 6 months post-radiotherapy suffer from of decreased UL function, i.e. difficulties in performing activities of daily living with the upper limb. Patients experiencing UL dysfunctions and other problems are less likely to be physically active. Given that physical inactivity is associated with an increased risk of mortality after breast cancer, taking away the barriers to physical activity (e.g. UL dysfunctions) is very important. Identifying these factors contributing to chronic UL dysfunction is important in terms of identifying targets for prospective evaluation and specific treatment approaches at specific time points during breast cancer treatment.

There is a need to rethink the follow-up strategy (besides the treatment of the cancer itself) and develop a clinical care pathway consisting of multifactorial screening instruments to identify women and men who are in need of extra rehabilitation efforts and specific rehabilitation goals to alleviate symptoms and side effects experienced by breast cancer survivors. This clinical care pathway should cover all aspects of the International Classification of Function, Disease and Health (ICF), a biopsychosocial framework that conceptualizes a person's level of functioning and bodily structures, activity and participation and contextual factors (including personal and environmental factors).

The present study aims to identify the factors, during and after breast cancer treatment, contributing to persistent Upper Limb (UL) dysfunctions.

Identifying Prognostic Variables for Persistent Upper Limb Dysfunctions After Breast Cancer Treatment

Identifying Prognostic Variables for Persistent Upper Limb Dysfunctions After Breast Cancer Treatment: Longitudinal Cohort Study

quickDASH (0-100) questionnaire: An abbreviated version of the original DASH (Disabilities of the Arm, Shoulder and Hand) outcome measure. The questionnaire contains 11 items that measures an individual's ability to complete tasks, absorb forces and severity of symptoms, with a 5-point Linkert scale.

Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.

Accelerometry: duration of upper limb use (hours) during one week.

Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.

Basic inspection of skin deformities, asymmetry, presence of scapular winging or other scapular or shoulder deformities.

Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.

Numeric Rating Scale (0-10) of pain intensity during movement during the week before assessment.

Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.

Presence of neuropathic pain (yes/no):

Douleur Neuropathique en 4 questions (DN4) is a questionnaire generated for identifying pain of predominantly neuropathic origin. The DN4 consists of 7 self-reporting questions and 3 clinical examinations. A scoring of ≥4/10 is considered as a positive result for neuropathic pain.

Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.

Presence of sensory loss (yes/no) Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.

Presence of widespread pain (yes/no)

Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.

Brief Pain Inventory: the short version assesses the the impact of the pain on functioning.The Brief Pain Inventory is a valid multimodal scale for assessing pain in breast cancer patients.

Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.

The MyotonPRO assessment for soft-tissue stiffness and elasticity will take place at the pectoralis major, upper trapezius, infraspinatus and teres major region, from which a mean stiffness index (N/m) will be calculated.

Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.

Relative arm volume: Bilateral circumferential measurements using a perimeter will be performed.

Water displacement method hand: Bilateral water displacement method using a volumeter filled with water and allowed to settle at room temperature will be performed.

Afterwards the total volume (mL) can be calculated by taking the sum of the two measurements.

Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.

The 3D scapulothoracic and glenohumeral movements will be assessed using inertial sensors (MTw motion capture, Xsens Technologies, The Netherlands) at the endpoint (i.e. point of task achievement) of the performance of a functional task, the Upper Limb Function Test (ULIFT), which is a valid and reliable test to assess upper limb functionality in breast cancer patients.

Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.

A hand-held dynamometer will be used to assess handgrip strength

Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.

Pain Catastrophizing Scale (0-52) : It is a self-report measure, consisting of 13 items scored from 0 to 4, resulting in a total possible score of 52. The higher the score, the more catastrophizing thoughts are present.

Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.

General Self-Efficacy Scale:This scale is a self-report measure of self-efficacy with 10 items (scored from 1-4). The total score is calculated by finding the sum of the all items. The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.

Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.

Depression, Anxiety and Stress Scale (DASS-21) (range 0-132). The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress

Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.

Adjusted 11-item Tampa Scale of Kinesiophobia. Items are scored from 1 (strongly disagree) to 4 (strongly agree). Thus, total scores range from 11-44 points with higher scores indicating greater fear of pain, movement, and injury

Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.

A self-developed Dutch version of the Fremantle Shoulder Awareness Questionnaire will be used.

Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.

European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Core-30 item (EORTC QLQ-C30). The QLQ-C30 is a validated questionnaire that incorporates nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.

Through a self-developed questionnaire, patients will be questioned whether they received no/suboptimal/optimal physical therapy care

Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.

no/taxanes/non-taxanes and neo-adjuvant/adjuvant (derived from the medical file) Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.

no/aromatase inhibitor/no-aromatase inhibitor (derived from the medical file)

Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.

The 'Myofascial Adhesions in Patients after Breast Cancer (MAP-BC)'-tool will be used to assess the severity of soft tissue adhesions at the upper limb region (0-63) Assessment at pre-surgery baseline, 1 month post-surgery, 2 weeks post-chemotherapy (if applicable), 1 month post-radiotherapy and 6 months post-radiotherapy.

Universitaire Ziekenhuizen KU Leuven

Vrije Universiteit Brussel

KU Leuven

Prof. Dr

Digestive System Diseases

Symptoms and General Pathology

Blood and Lymph Conditions

Gastroesophageal Reflux

Edema

Lymphedema

Breast Cancer Lymphedema

Lymphatic Diseases

Postoperative Complications

high ratio of axillary lymphatic reflux to axillary vein reflux

low ratio of axillary lymphatic reflux to axillary vein reflux

The patients will undergo axillary lymph node dissection with preserved axillary vein branches

Branches Sparing

The patients will undergo axillary lymph node dissection without preserved axillary vein branches

None Branches Sparing

FEN TANG, MD

XIANGYUN ZONG, MD, PhD

XIANGYUN ZONG, MD, PHD

YANG YU, M.D.

HONGJIAN YANG, M.D.

The purpose of this study is to compare the difference in the incidence of upper limb edema and dysfunction between the Preponderant lymphatic reflux group (high ratio of axillary lymphatic reflux to axillary vein reflux) and the Preponderant venous reflux group (low ratio of axillary lymphatic reflux to axillary vein reflux).

Effect of the Axillary Lymphatic /Vein Reflux Ratio on Postoperative Upper Limb Edema and Dysfunction in Breast Cancer

Postoperative Upper Limb Edema and Dysfunction Generated by Axillary Nodes Excision Differs Due to the Ratio of Axillary Lymphatic and Axillary Vein Reflux in Breast Cancer Patients: a Prospective Cohort Study

Incidence of upper limb lymphedema and dysfunction on affected side after operation

Incidence of upper limb lymphedema on affected side after operation

Incidence of upper limb dysfunction on affected side after operation

Xiangyun Zong

Head of Breast Cancer, Principal Investigator, Clinical Professor

The patients in this arm will undergo axillary lymph node dissection with preserved axillary vein branches

The patients in this arm will undergo axillary lymph node dissection without preserved axillary vein branches

Spare the vein branches when ALND being performed

axillary lymph node dissection with vein branches reservation

Don't spare the vein branches when ALND being performed

axillary lymph node dissection without vein branches reservation

FEN TANG, M.D., Ph.D.P

XIANGYUN ZONG, M.D., Ph.D.P

The purpose of this study is to compare the effects of axillary lymph node dissection with or without axillary vein branches reservation on the affected upper limb edema and dysfunction in breast cancer patients, and to explore the solutions to prevent the affected upper limb edema and dysfunction after ALND.

Effect of ALND With Vein Branches Reservation on Postoperative Upper Limb Edema and Dysfunction in Breast Cancer

Postoperative Upper Limb Edema and Dysfunction Generated by Axillary Nodes Excision With or Without Axillary Vein Branches Reservation in Breast Cancer Patients: a Prospective, Multiple-center, Double-blinded, Randomized Controlled Study

Women and men in the prospective cohort study will be invited to participate in this additional validity and/or reliability testing

assessment for upper limb dysfunction

For the test-retest reliability testing, participants will be invited to have an additional appointment approximately 1 week after the main assessment.

retest assessment

Breast cancer is the most frequently occurring cancer, assuming that it accounts for 29% of all new cancers in women (European Cancer Information System). The number of long-term survivors is increasing rapidly due to improving accuracy of the detecting methods, the early diagnosis and advances in cancer treatment.

The International Consortium for Health Outcomes Measurement Initiative described upper limb (UL) function as the health outcome that matters most for breast cancer survivors (BCS). 50% of BCS at 6 months post-radiotherapy suffer from of decreased UL function, i.e. difficulties in performing activities of daily living with the upper limb. Patients experiencing UL dysfunctions and other problems are less likely to be physically active. Given that physical inactivity is associated with an increased risk of mortality after breast cancer, taking away the barriers to physical activity (e.g. UL dysfunctions) is very important. Identifying these factors contributing to chronic UL dysfunction is important in terms of identifying targets for prospective evaluation and specific treatment approaches at specific time points during breast cancer treatment.

This study aims to find reliable and valid assessment methods for the prognostic factors and upper limb function itself in a small group of BCS and healthy volunteers.

Identifying Prognostic Variables for Persistent UL Dysfunctions After Breast Cancer Treatment -Reliability and Validity

Inter- and intra-rater reliability will be tested. The MyotonPRO assessment for soft-tissue stiffness and elasticity will take place at the pectoralis major, upper trapezius, infraspinatus and teres major region, from which a mean stiffness index (N/m) will be calculated.

approximately 1 week between test \& retest

The validity of the evaluation tool for Myofascial Adhesions in Patients after Breast Cancer (MAP-BC evaluation tool), developed during PhD project of Prof. An De Groef will be investigated. This clinical assessment tool consists of the assessment of soft-tissue adhesion at 7 locations at the upper limb region: axillary and breast region scars, pectoral region, axilla, frontal chest wall, lateral chest wall and the inframammary fold. At each location, the degree of the adhesions will be scored at three levels (skin, superficial and deep) on a 4-point scale (between no adhesions and very stiff adhesions).

results will be compared with the results of the Myoton pro. approximately 1 week between test \& retest

Palpation for general tissue stiffness scored on a Linkert Scale (0-5) at the different locations will be explored and the sum of total score of all locations will be calculated (0-35).

results will be compared with the results of the Myoton pro. approximately 1 week between test \& retest

The reliability of goniometer, digital goniometer (EasyAngle®, Meloq AB, Stockholm) and inclinometer will be assessed for the following tasks: shoulder abduction, flexion, external rotation, and the ULIFT functional task. The inertial sensors are easy to use in daily practice, portable but come with a high cost in comparison to a goniometer, digital goniometer or inclinometer.

The scapular movement assessment of the inertial sensors will be compared with the results of the inclinometer and digital goniometer. The glenohumeral movements will be compared with the results of the goniometer, digital goniometer and inclinometer.

approximately 1 week between test \& retest

The validity of goniometer, digital goniometer (EasyAngle®, Meloq AB, Stockholm) and inclinometer will be assessed for the following tasks: shoulder abduction, flexion, external rotation, and the ULIFT functional task. The inertial sensors are easy to use in daily practice, portable but come with a high cost in comparison to a goniometer, digital goniometer or inclinometer.

The scapular movement assessment of the inertial sensors will be compared with the results of the inclinometer and digital goniometer. The glenohumeral movements will be compared with the results of the goniometer, digital goniometer and inclinometer.

approximately 1 week between test \& retest

The accelerometer to evaluate upper limb functioning will be validated against video annotated data as proposed by Lum and colleagues. Established methods use a machine learning pipeline to accurately and automatically recognize functional upper limb activities from accelerometer data in healthy subjects. These models will be evaluated against video annotated data to assess accuracy and correlation for our subsample of breast cancer survivors.

approximately 1 week between test \& retest

Hot/cold tubes will be used for the cold and heat detection, but to validate this assessment method is will be compared with thermorollers.

approximately 1 week between test \& retest

The accelerometer will be used as comparable sign and dependent variable to evaluate the upper limb function to capture the 'activity and participation level' of the ICF model.

approximately 1 week between test \& retest

The quickDASH will be used as comparable sign and dependent variable to evaluate the upper limb function to capture the 'activity and participation level' of the ICF model.

The QuickDASH is a shortened version of the DASH Outcome Measure. The QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb. The resultant score is reported on a scale of 0 to 100, where 0 represents no disability and 100 represents total disability

approximately 1 week between test \& retest

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Identifying Prognostic Variables for Persistent Upper Limb Dysfunctions After Breast Cancer Treatment	NCT05297591	Breast Cancer	assessment of U...	18 Years -	KU Leuven
Effect of the Axillary Lymphatic /Vein Reflux Ratio on Postoperative Upper Limb Edema and Dysfunction in Breast Cancer	NCT05246592	Breast Cancer L...	Branches Sparin... None Branches S...	18 Years - 69 Years	Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Effect of the Axillary Lymphatic /Vein Reflux Ratio on Postoperative Upper Limb Edema and Dysfunction in Breast Cancer	NCT05246592	Breast Cancer L...	Branches Sparin... None Branches S...	18 Years - 69 Years	Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Effect of ALND With Vein Branches Reservation on Postoperative Upper Limb Edema and Dysfunction in Breast Cancer	NCT05120180	Breast Cancer L...	axillary lymph ... axillary lymph ...	18 Years - 69 Years	Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Identifying Prognostic Variables for Persistent UL Dysfunctions After Breast Cancer Treatment -Reliability and Validity	NCT05371847	Breast Cancer	assessment for ... retest assessme...	18 Years -	KU Leuven

Spots Global Cancer Trial Database for upper limb dysfunction