prevention of lymphedema after breast cancer surgery

Phase 2

Not yet recruiting

Conditions: Malignant neoplasm of breast of unspecified site,

Registration Number: CTRI/2019/07/020436

Lead Sponsor: AIIMS New Delhi

Brief Summary: Breast cancer is on the rise in India and there is a dearth of awareness of the problem and its consequences in our society. Hence many patients present with advanced stage of disease where the tumor has already metastasized to the lymph nodes. Axillary lymph node status provides important prognostic information in invasive breast cancer. It is also important in staging and guiding treatment decisions. Fisher et al were the first to support the hypothesis that axillary dissection has prognostic significance . This led to the use of various options in the management of axilla including axillary lymph node dissection (ALND), axillary clearance, axillary dissection with regional lymph node radiation, regional radiation alone, axillary sampling, sentinel lymph node biopsy (SLNB) and observation .

Complete axillary dissection was considered to be a mandatory part of the surgical care of breast cancer until the 1980s. More recently, several factors have caused many practitioners to reevaluate the role of routine axillary dissection in the treatment of breast cancer . Several trials (including NSABP B-04, B-32, AMAROS, Z-0011) have shown that axillary surgery does not affect the overall survival of patients .

ALND is associated with a variety of complications like lymphedema of arm, pain/anaesthesia/paraesthesia of arm and shoulder region, seroma formation, infection, restriction of shoulder movements. Axillary ultrasonography guided FNAC accurately predicted the axillary status in 80-85% of patients and had a sensitivity of 28.5% for preoperative detection of axillary nodal metastasis.

Breast cancer related lymphedema (BCRL) is a chronic swelling of the upper limbs following surgical removal of axillary lymph nodes. It was first described by Handley in 1908 . In 1921, Halsted coined the phrase â€œElephantiasis Chirurgicaâ€. BCRL in varying degrees of severity remains a debilitating and often incurable complication of breast cancer treatment . The factors that might influence the development of secondary lymphedema after surgery are the number of lymph nodes removed, radiotherapy to the axilla, postoperative wound infection, post-surgical drainage time, lack of mobility, and obesity.

.Early, consistent, and ongoing treatment is necessary to limit the amount of extremity swelling. The conservative (nonsurgical) treatment of established lymphedema consists of a multimodality regimen, including general self-care measures (exercise, skin care), compression therapy, and physiotherapy .

Complete axillary dissection was considered to be a mandatory part of the surgical care of breast cancer until the 1980s.

Prevention is of key importance to avoid lymphedema occurrence. Treatment for lymphedema remains suboptimal and is, in most cases is palliative with a goal of preventing the disease progression rather than a cure. Medical and surgical treatments have been reported with varying successLymphedema is complicated by infection of the skin and deep tissues in approximately 40% of cases, irrespective of what is the primary etiological factor for the development of this condition. In the upper extremities after mastectomy and local irradiation, infection of the swollen limb, expressed as acute and later as chronic inflammation, ranges between 20% and 40%.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 320

Inclusion Criteria

1.Women above the age of 18 years with metastatic palpable axillary lymph nodes confined to level 1 with invasive breast cancer in the ipsilateral breast.
2.Locally advanced breast cancer patients who have received neoadjuvant chemotherapy.( T3N0,T3N1, ).

Exclusion Criteria

1.Women with inflammatory breast cancer, skin involvement and chest wall involvement as they should undergo complete axillary lymph node dissection.
2.Pregnant women 3.Lactating women 4.Women refusing to sign consent form.
5.Patients allergic to injection Benzathine penicillin 6.Patients with advanced disease including N3, and metastatic disease.
7.Upper limb swelling with deep vein thrombosis 8.Acute infections of upper limb.
9.Refusals for consent for randomization or long follow up.
10.Patients with established upper limb lymphedema.
(Pre operative difference of >2cm in both upper limbs circumference).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Risk of lymphoedema	week 4 ,8, 12, 24 and week 52

Secondary Outcome Measures

Name	Time	Method
Surgical site infection.	Quality of life score.

Trial Locations

Locations (1): AIIMS
🇮🇳
South, DELHI, India
AIIMS
🇮🇳South, DELHI, India
Dr Anita Dhar
Principal investigator
09810198239
dranitadharbhan@gmail.com