Postmastectomy lymphedema syndrome. This code is specifically used to classify lymphedema as a direct complication of mastectomy (surgical removal of the breast), often due to lymph node removal or damage to lymphatic vessels during the procedure.
Conditions
Interventions
Intervention 1: Intervention group: Participants in this group, after a complete evaluation, will simultaneously receive two interventions over a period of 8 weeks under the supervision of an experien
Sponsors
Semnan University of Medical Sciences
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Women diagnosed with upper limb lymphedema secondary to breast cancer Referred by a physician for participation in the study Less than six months had passed since the end of chemotherapy or radiotherapy treatment for breast cancer Average time elapsed since breast cancer surgery between 5 to 6 months
Exclusion criteria
Exclusion criteria: History of bilateral mastectomy Metastatic breast cancer Planned breast reconstruction within the next 6 months Severe and unstable cardiac diseases (e.g., decompensated heart failure, unstable ischemic heart disease, moderate to severe valvular heart disease, aortic aneurysm) Moderate to severe chronic obstructive pulmonary disease (COPD) Severe untreated hypertension Pulmonary hypertension and chronic respiratory failure Advanced liver failure Severe anemia (hemoglobin less than 8 g/dL) Severe physical disabilities or mental impairments preventing participation Refusal to cooperate with the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in upper limb volume (in milliliters), calculated by circumferential measurements at specified points using a measuring tape and converted to volume using standard formulas. Timepoint: The time points for measuring the primary outcomes include three stages: assessment at the beginning of the study (before the start of the intervention), assessment after the completion of the eight-week Complete Decongestive Therapy intervention, and a follow-up assessment in the twelfth week (four weeks after the end of the intervention) to evaluate the sustainability of the outcomes. Method of measurement: To assess the volume of upper limb edema, circumferential measurements are taken at specific points on the limb using a measuring tape. The limb volume is then calculated in milliliters using standardized formulas. Measurement points include the metacarpophalangeal region, mid-metacarpals, wrist, distal quarter of the forearm, mid-forearm, proximal quarter of the forearm, mid-arm, and the axillary line.;Grip strength will be measured using a hand-held dynamometer (Hydraulic Hand Dynamometer, Model 1J5030, JAMAR). Timepoint: The time points for measuring the primary outcomes include three stages: assessment at the beginning of the study (before the start of the intervention), assessment after the completion of the eight-week Complete Decongestive Therapy intervention, and a follow-up assessment in the twelfth week (four weeks after the end of the intervention) to evaluate the sustainability of the outcomes. Method of measurement: For grip strength assessment, a handheld dynamometer model dynamometer hydraulic 1J5030 JAMAR will be used. Participants are asked to hold the dynamometer, keep their elbow flexed at 90 degrees and shoulder in a neutral position. Then, they squeeze the dynamometer with maximum effort. This process is repeated three times, and the highest value from each hand will be recorded. | — |
Secondary
| Measure | Time frame |
|---|---|
| The quality of life score of patients was measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Core 30 items (EORTC QLQ-C30). Timepoint: The time points for measuring the primary outcomes include three stages: assessment at the beginning of the study (before the start of the intervention), assessment after the completion of the eight-week Complete Decongestive Therapy intervention, and a follow-up assessment in the twelfth week (four weeks after the end of the intervention) to evaluate the sustainability of the outcomes. Method of measurement: To assess the quality of life of patients, the Persian version (third edition) of the “European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Core 30 items” (EORTC QLQ-C30) will be used. This self-administered questionnaire consists of 30 items and evaluates the quality of life of cancer patients across five functional domains (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), nine symptom domains (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and one global quality of life domain. Scoring interpretation varies depending on the domain type: higher scores in the functional domains and global health status indicate better quality of life, while higher scores in the symptom domains reflect more severe symptoms. Therefore, improvement is reflected by increased scores in functional domains and decreased scores in symptom domains. Several validation studies conducted in Iran have confirmed the reliability and validity of this tool. For instance, in the study by Kahrizi et al. (2011), Cronbach’s alpha coefficients were reported as 0.65 for fatigue, 0.69 for pain, 0.66 for nausea and vomiting, and above 0.70 for other subscales. In another study by Akbari et al. (2014), Cronbach’s alpha values ranged from 0. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSara Vasheghani Farahani
Semnan University of Medical Sciences
Outcome results
None listed