To compare the effectiveness of Compression pump with Multiple Layered Bandaging in swelling of Arm Developed after surgery of Breast Cancer patients.
Phase 2
- Conditions
- Health Condition 1: null- BREAST CANCER PATIENTS
- Registration Number
- CTRI/2018/02/011708
- Lead Sponsor
- Advanced Centre fot Treatment research and Education in Cancer Tata Memorial Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.CA breast patients with secondary lymphoedema only
2. female patients of age group 18-75 years only.
3.Lymphoedema of International Society of Lymphology (ISL) Staging II
4.Post completion of primary treatment excluding hormonal therapy
Exclusion Criteria
1.Patients having bilateral lymphoedema.
2.Patients with recurrent disease
3.Patients with acute neuropathy
4.Patients who received radiation in Axilla
5.Patients with compromised cardiac condition
6.Patients with Upper Limb DVT
7.Patients with acute infections like lymphangitis
8.Patients in palliative care.
9.Patients included in any other similar study.
10.Non compliant patients
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point: <br/ ><br>To compare percentage reduction of affected arm volume between study and control arm in 3 weeks. <br/ ><br> <br/ ><br>Secondary end point: <br/ ><br> <br/ ><br>1)To find percentage of excess volume in affected arm compared to normal arm at 3rd week. <br/ ><br>2)To follow up arm volume in the affected arm at 4-6 months from the date of intervention.. <br/ ><br>3)To find relation between Body Mass Index (BMI) and response to the chosen intervention. <br/ ><br>4)To find effect on Pain score <br/ ><br>5)To find changes in quality of life. <br/ ><br> <br/ ><br>Timepoint: outcomes will be assessed at baseline, 3rd week of intervention and at follow up after 4-6 months.
- Secondary Outcome Measures
Name Time Method 1)To find percentage of excess volume in affected arm compared to normal arm at 3rd week. <br/ ><br>2)To follow up arm volume in the affected arm at 4-6 months from the date of intervention.. <br/ ><br>3)To find relation between Body Mass Index (BMI) and response to the chosen intervention. <br/ ><br>4)To find effect on Pain score <br/ ><br>5)To find changes in quality of life. <br/ ><br> <br/ ><br>Timepoint: outcomes will be assessed at baseline, 3rd week of intervention and at follow up after 4-6 months.