To study the influence of prophylactic application of the class 2 upper limb stockings in carcinoma breast patients in reducing the incidence of Breast cancer related lymph edema [BCRL]
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Percentage of reduction in arm volume in the study group will be analyzed which will indirectly give the reduction in the incidence of lymph edema.
Study Overview
Brief Summary
The incidence of Breast carcinoma related lymphedema [BCRL]is around 10 to 20 % and the incidence among Indian population is unknown. The lymphatic obstruction is been proposed as the main cause of the development of the lymph edema .But Venous hypertension is a coexisting feature of lymphoedema. Kim et al showed venous insufficiency in all 41 patients in their series with lymphoedema. All patients had increased venous pressure and volume with a decreased ejection fraction, all of which were proportional to the size of the swollen leg. Increased blood flow has been recorded in post mastectomy lymphoedema. This was thought to worsen the oedema present. Jacobsson [89] using radioactive isotope clearance showed a 42% increase in blood flow in 25 such arms. An increase in arterial flow that increases venous filling and causes venous hypertension was postulated. Svensson noted that 70% of post mastectomy lymphoedema patients had abnormal arm venous outflow. Solti suggested that the increased blood flow through the arm together with arteriovenous shunting caused by angiogenesis in lymphoedematous arms may lead to increased venous pressure.Based on these findings we proposed that by applying class 2 elastic compression stocking, the axillary venous outflow will increase and there by the venous hypertension will not be detrimental to the arm .The study design is double arm single blinded randomized controlled trial. Patients who undergo surgery for carcinoma breast will be randomized into two arms before the surgery.The arm volume and the arm circumference will be measured by a group of nursing staff who is blinded to the intervention. Post operatively within 24 hrs, according to the computer generated randomization nos, one group will receive the Class 2 elastic compression stocking from Siguvaris. The measurement will be taken on the 10th post operative and 90th day. The groups will be matched for the extent of the surgery and the disease and the analysis will be done
Study Design
- Allocation
- Computer generated randomization
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
Inclusion Criteria
- •All patients who needs surgery for carcinoma breast.
Exclusion Criteria
- •Known filarial lymphodedma patients
- •Hypothyroid status
- •Fractures or other vascular anomaly /surgery in the arm.
Outcomes
Primary Outcomes
Percentage of reduction in arm volume in the study group will be analyzed which will indirectly give the reduction in the incidence of lymph edema.
Time Frame: on the 10 th post operative day and three months follw up
Secondary Outcomes
- Incidence of lymph edema(at the end of one year)