Study Sample
Patients with BCRL who had submitted to lymphedema unit of the Physical Medicine and Rehabilitation Department, in a university hospital, were enrolled to the study between January 2014-August 2016. All the patients agreed to participate in the study. Written informed consent was obtained prior to the study from all subjects. Approval for the study was granted by the non-invasive clinical research ethical committee of our University (GO-14-554) and the study was conducted in accordance with the principles of Declaration of Helsinki.
Eligibility
The inclusion criteria were as follows: 1) age being between 18-65, 2) having unilateral breast cancer surgery 3) a volume difference depended to the circumferential measurements between the affected and unaffected upper extremities of more than 10%, 4) having completed chemotherapy and/or radiation therapy 5) complied and fully attended CDT five times per week for 3 weeks. Patients were excluded according to the following criteria: 1) patients with edema before breast cancer treatment, 2) patients with history of contralateral breast cancer, 3) medical history comprising other causes of lymphedema 3) having recurrence or metastasis of breast cancer 4) having contraindicated condition for CDT (renal insufficiency, congestive heart failure, infection, thrombosis, thyroid or abdominal disease, severe vascular disease, etc), 5) having had prior any therapy for lymphedema.
Demographic and Clinical Data
Demographic properties comprising age, gender, body mass index, education, marital status, occupation, regular exercise habit, hand dominancy, lesion site were recorded. Breast cancer treatments (type of surgery, histopathological diagnosis, cancer stage, adjuvant treatments like radiation therapy, chemotherapy, hormonal therapy) were determined in all patients.
Volume measurements and lymphedema Data
The presence of lymphedema was assessed by inter-limb volume difference (> 10%) based on the serial circumferential measurements in both affected and non-affected extremities (33). For circumferential measurements subjects sat straight on a chair with their arms relaxed by their sides and elbows straight. Both arms were measured at each test date. Circumferential measurements were performed by a standard 1 inch retractable tape, starting at the level of ulnar styloid, at 4 cm intervals along the arms and converted to an approximate arm volume to enable estimation of volume (34,35). Calculation of the limb segment volumes (millimeter) was undertaken using a simplified truncated cone formula. Excess limb volume comparing affected and unaffected limbs and difference in excess volume (The excess limb volume is expressed as a percentage of the unaffected limb volume indicating how much larger the affected limb is compared to the unaffected limb) were calculated (35). Every patient was assessed by the same physiotherapist.
Lymphedema characteristics including duration of lymphedema, type of lymphedema (subclinical, reversible, spontaneous irreversible, elephantiasis) initial side (proximal, distal), positivity of Stemmer sign were assessed. The stages of lymphedema are categorized according to International Society of Lymphology (ISL) (33). ISL staging ranges from 0 to III and involves two criteria: the "softness" or "firmness" of the limb (reflecting fibrotic soft tissue changes) and the outcome after elevation. Within stages I through III, severity based upon volume differences is assessed as mild (<20 percent increase), moderate (20 to 40 percent increase), or severe (>40 percent increase). Stage "0" lymphedema is a subclinical or latent condition where swelling is not evident despite impaired lymphatic transport.
Health-Related Quality of life (HRQOL) Assessments
Health-Related Quality of life was assessed by the Turkish version of European Organization for Research and Treatment of Cancer Core Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and its breast cancer specific complementary measure (EORTC QLQ BR23) (36). EORTC-QLQ-C30 is a 30 item self-administered cancer specific questionnaire designed to measure QoL in the cancer population. The assessment is comprised of nine domains (physical, role, cognitive, emotional, social, fatigue, pain, nausea and vomiting) categorized as global health status, functional scale and symptom scales (37). EORTC-QLQ-Br23 is a 23 item self-administered breast cancer specific questionnaire, usually administered with the EORTC-QLQ-C30, designed to measure QoL in breast cancer population at various stages and with patients with differing treatment modalities. The assessment is comprised of eight domains (body image, future perspective, sexuality domains, arm symptoms, breast symptoms and systemic therapy side effects, hair loss) categorized as functional scales and symptom scales (37).
Functional Assessments
Functional disability of the affected extremity was evaluated by quick Disability of Arm, Shoulder and Hand questionnaire (DASH) (38). It is a self-report questionnaire evaluating the patients’ symptoms and functional tasks associated with limitations of the arm, shoulder and hand. It is validated for Turkish population with upper limb problems. It contains 11 items and results in a score ranging from 0-100 with higher scores indicating more functional disability (39).
Complex Decongestive Therapy Protocol
All the patients underwent a standard protocol of CDT comprising skin care, manual lymphatic drainage, short-stretch multilayer bandaging and lymphedema exercises, five sessions per week for a duration of three weeks in the outpatient lymphedema unit, by an experienced certified lymphedema therapist. All patients were educated for lymphedema including skin care and maintenance of healthy body weight and delivered a written lymphedema brochure for general advices in the first day of the treatment.
The MLD consisted of four basic techniques (stationary circle, rotary, pump and scoop techniques) and, was performed in a proximal to distal direction with light skin strokes, with duration of 45 minutes. Cervical area, abdominal area, anterior trunk, and posterior trunk anastomoses were covered in a standard manner. Finally the whole limb was massaged from proximal to distal parts of the extremity (40).
After the MLD, short-stretch multilayer bandages were performed and changed daily except the weekends. A cotton tube stockinet was placed on the arm at first, then finger bandaging was applied. A layer of padding bandage was placed on the hand and wrapped around the arm. Four short stretch bandages (6,8,10,12 cm in width) were sequentially placed around the limb with the first starting at the hand, the second at the wrist, and the third and fourth starting below the elbow. Multiple layer compression bandages were applied such that the most compression was at the distal parts and the compression decreased gradually moving to proximal sites.
All subjects were provided individualized active exercise program 20 minutes per day under the supervision of an experienced physiotherapist, including diaphragmatic breathing exercise, neck and shoulder stretching, hand pumping and non-isometric strengthening of arm muscles, in order to help facilitate lymphatic flow and improve strength and range of motion. The exercises were performed with the bandages.
Outcome Measures
The difference in volumes, excess volumes, HRQoL and functional assessment scores were evaluated at baseline and after the phase 1 CDT in all patients. The primary outcome measures were the reduction in volumes and excess volumes, between the arms while the secondary outcomes included HRQOL and functional scores. The related factors with improvement of the lymphedema were also determined in all patients.
Statistical analysis
Descriptive statistics were used to examine the frequency distributions and calculate the scores of scales and subscales, and defined with mean ± standard deviation, median and percentage values. The continuous variables have been tested for each group for normal distribution using the Shapiro Wilk test. Student t test or Mann Whitney test were used compare differences in quantitative variables before and after the study. The relationship between improvement of volume differences and HRQoL scores, Lymphedema symptoms and arm disability scores were assessed using Pearson's correlation for parametric data and with spearman's rho (correlation) for nonparametric data. All tests of statistical significance were two sided and considered statistically significant at p<0.05. Analyses were conducted by SPSS 21.0 statistical package.